The Scope of Things

Episode: 49 - Mike Sullivan on AI and Clinical Operations in the Year 2030

Tue, 07 Apr 2026 08:00:00 -0400

What will AI and clinical trials look like in the year 2030? Mike Sullivan, head of IT globally for development operations at Bristol Myers Squibb, joins The Scope of Things to discuss how creating value with AI depends on redesigning how clinical operations teams work. He covers the four pillars of what AI and clinical operations can look like in the next few years, as well as how AI will affect the job market. Plus, host Deborah Borfitz gives you the latest rundown on building the capacity to collaborate with patients, a new playbook for pediatric clinical trial reporting, lithium treatment for verbal memory decline, sex-specific effects of dementia, open-source database for scaling cancer trials, and a proposed 10-year trial of anti-obesity drugs for preventing obesity-related cancers.

Show Notes

News Roundup

Power dynamics in researcher-patient relationships

Study published in Health Expectations

Playbook forpediatricclinical trial reporting

Statement on reporting protocols published in The BMJ
Statement on reprintng completed trials published in The BMJ

Low-dose lithium for slowing verbal memory decline

Study in JAMA Neurology
News on the University of Pittsburgh Medical Center website

Parkinson's-related protein linked to faster Alzheimer's progression in women

Study in JAMA Network Open
Press release on the Mayo Clinic website

AstroID database for studying cancer

Study in Journal for Immunotherapy of Cancer
News release on the Johns Hopkins website

Anti-obesity drugs for preventing cancer

News release from the European Congress on Obesity

Guest

Mike Sullivan, head of IT globally for development operations at Bristol Myers Squibb

The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.

Episode: 48 - Florence Mowlem on the Challenges and Solutions of Pediatric Rare Disease Trials

Tue, 10 Mar 2026 08:00:00 -0400

How can electronic capture of clinical outcome assessments (eCOA) help with the unique challenges of pediatric rare disease trials? Florence Mowlem, chief scientific officer of uMotif, joins The Scope of Things to offer her expertise on eCOA, share advice for companies on vetting technology providers, and discuss where sponsors are tripping up when it comes to pediatric rare disease trials. Plus, host Deborah Borfitz brings you the latest news on a possible probiotic for preventing immune system disorders in babies, misunderstood mechanisms of body weight regulation, a promising primary care-based weight management program, GLP-1 drugs potentially benefitting the brain, how patient-reported outcomes can improve clinician adverse event reporting, and a discovery-to-reimbursement model for cell and gene therapies.

Show Notes

News Roundup

Preventing allergies and asthma

Study in Nature Microbiology
News from the Technical University of Denmark

Competing body weight regulation theories

Study in Nature Reviews Endocrinology
News on the Pennington Biomedical Research Center website

PATHWEIGH weight management process

Pragmatic study in Nature Medicine
News on the University of Colorado Anschutz website

Diabetes drugs reduce risk of dementia

Study in Drug Safety
News on McGill University website

PRO data improved side effect grading

Study in The Lancet Oncology
Blog post on EORTC website

Development model for cell and gene therapies

Research article in Molecular Therapy, Methods and Clinical Development
News on the Lund University website

Guest

Florence Mowlem, chief scientific officer at uMotif

Episode: 47 - Joseph Kim on Pragmatic Solutions to Age-Old Problems

Tue, 03 Feb 2026 08:00:00 -0500

Joining this month’s episode of The Scope of Things is Joseph Kim, chief strategy officer of ProofPilot, who talks about his company’s first-ever CORE Symposium, where pharma pros shared practical solutions to age-old trial challenges. Kim provides a pragmatic viewpoint on the problematic trio of clinical trials—study execution, recruitment, and engagement—and what change agents are needed to pave the way forward and find an exit from the bottlenecks. Plus, host Deborah Borfitz delivers the latest on a planned mapping of clinical trial deserts, the high cost of accelerated FDA approvals, the best states for cancer research, the world’s first in-ear EEG system getting approved, and a new smartphone-based outcome measure for sleep studies.

News Roundup

Financial hurdles to trial enrollment

Study in the Journal of the National Comprehensive Cancer Network
News on the Case Western Reserve University website

Accelerated cancer drug approvals

Study in BMJ Medicine

Best states for cancer research

Blog on SmileHub website

In-ear EEG devices

Article in Diagnostics World News

Ecological momentary assessment in sleep-focused trial

Study in JAMA Network Open

Guest

Joseph Kim, chief strategy officer for ProofPilot

Episode: 46 - Dan Drozd on How Noninterventional Studies Can Change the Clinical Research Game

Tue, 06 Jan 2026 09:00:00 -0500

Noninterventional studies in clinical research are underutilized in clinical research and inefficient. Dan Drozd, CMO of PicnicHealth, knows we can do better. With host Deborah Borfitz, Drozd discusses the issues and ramifications researchers face from the lack of noninterventional studies, offers tactics for raising the bar for evidence generation, and shares what he expects in the clinical research space in 2026 in this episode of the Scope of Things. Plus, Borfitz shares the latest news on an expanding good pharma score card, an entirely telehealth-based cancer trial, a novel online platform for bowel cancer research, improving patient-reported outcomes in cancer trials, a virtual clinical trial for psychedelics, and identifying Type 1 diabetes in the symptom-less window stage.

Show Notes

News Roundup

Good Pharma Scorecard

Study in JAMA Internal Medicine
News on the Yale Scool of Medicine website

Nationwide telehealth trial for cancer

News on The Ohio State University website

Online platform for bowel cancer research

News on the Newcastle University website

Patient-reported outcomes in cancer clinical trials

Paper in The Lancet Oncology
News on the European Organisation for Research and Treatment of Cancer website

Virtual clinical trial of psychedelics

Research article in Advanced Science

Type 1 diabetes risk prediction testing

Study in The Lancet
News on the University of Exeter website

Guest

Dan Drozd, M.D., CMO of PicnicHealth

Episode: 45 - Doug Bain on Streamlining Clinical Trials

Tue, 02 Dec 2025 09:00:00 -0500

Doug Bain, founder and consulting partner of ClinFlo, discusses his proposed regulatory blueprint for digital trials in the latest episode of The Scope of Things podcast. With host Deborah Borfitz, Bain delves into his strategy for turning 21 CFR Part 11 into a more practical regulation that streamlines rather than bogs down clinical trials, what would qualify someone to take on the role as a trusted third party (and what makes them trustworthy), and the new FDA administration’s modernization plan aligns—or squares—with his ideas. Plus, the latest news on a tool for detecting fraud and sampling bias in decentralized trials, technology for identifying potentially dangerous drugs before trials start, a novel women’s health and menopause initiative, a regenerative therapy for spinal cord injury, and a new oral treatment for preventing dementia.

Show Notes :

News Roundup

Data collection tools for decentralized trials

MyTrials platform study in the Journal of Clinical and Translational Science

Real-time data integration tool

Press release on the Mount Sinai website

Drug toxicity prediction

Article in EbioMedicine

Tufts Women’s Health and Menopause Initiative

News from Tufts University

Regenerative therapy for spinal cord injury

Article in Nature

Oral treatment for preventing dementia

Press release from Aarhus University

Guest

Doug Bain, founder and consulting partner of UK-based ClinFlo

Episode 44 - SCOPE Europe 2025 on AI Literacy Training, Reducing Excess Data Collection, Combating Superbugs

Tue, 04 Nov 2025 09:00:00 -0500

This episode of the Scope of Things features an exclusive panel at SCOPE Europe 2025 covering regulatory requirements for AI literacy training, featuring industry executives Jonathan Crowther, head of the operational design center at Merck KGaA; Janie Hansen, global development information management, business systems transformation at Daiichi Sankyo; Francis Kendall, head of statistical programming, digital and data sciences at Biogen; and James Weatherall, vice president and chief data scientist of biopharmaceuticals R&D at AstraZeneca. Plus, host Deborah Borfitz gives the latest news on efforts to reduce excess data collection in studies, whole genome sequencing of breast cancer, a virus cocktail to combat superbugs, and more.

Show Notes
News Roundup

Collaborative study on data collection in trials

News posted on the TransCelerate website

Heart benefits of semaglutide

Study in The Lancet

Whole genome sequencing of breast cancers

Study in The Lancet Oncology

Pan-cancer immunotherapy heads to trials

Research article in Cell
Article in Bio-IT World

Promising NAD+ “youth molecule”

Review article in Nature Aging

Virus cocktail to combat superbugs

Article in Nature Microbiology

AI annotates medical images

News posted on the MIT website

Fitbits aid precision health

American Life in Realtime study in PNAS Nexus

Latest from the Human Epilepsy Project

Study in JAMA Neurology

Imposter study participants

Editorial in The BMJ

Guests

Jonathan Crowther, Ph.D., Head, Operational Design Center, Merck KGaA, Darmstadt, Germany
Janie Hansen, Global Development Information Management, Business Systems Transformation, Daiichi Sankyo
Francis Kendall, Head of Statistical Programming, Digital and Data Sciences, Biogen
James Weatherall, Ph.D., Vice President & Chief Data Scientist, BioPharmaceuticals R&D, AstraZeneca

Episode: 43 - Overcoming the Deadlock in Patient Recruitment With Christine Senn

Tue, 07 Oct 2025 08:00:00 -0400

For decades, clinical trial recruitment has been the biggest challenge in the industry. Christine Senn, senior vice president of Site-Sponsor Innovation at Advarra, offers insights into why the struggle continues, such as delays in getting regulations updated after a quarter of a century, and how to overcome the deadlock in clinical trial recruitment that is tied to current obsolete marketing guidelines. Also, host Deborah Borfitz shares the latest on beta blockers, low dose aspirin lowering the risk of recurring colorectal cancer, repurposing drugs for breast cancer relapse prevention, remote participation research on why athletes and military members face higher ALS risk, and the first agentic AI platform for life sciences from Medable.

Show Notes

News Roundup

Rethinking beta blockers

Press release on the Mount Sinai website
Subgroup analysis study in the European Heart Journal

Aspirin lowers risk of colorectal cancer recurrence

Study in The New England Journal of Medicine

CLEVER study to prevent breast cancer relapse

Study in Nature Medicine
News release on Penn Medicine website

Champion Insights ALS initiative

News release on Answer ALS website

Medable’s Agent Studio

Press release on the Medable website

Disseminating research findings

Systematic review in PLOS Medicine

Guest

Christine Senn, Ph.D., senior vice president of site-sponsor innovation at Advarra

Episode: 42 - Myeloma Research on a Global Scale with Joseph Mikhael

Tue, 09 Sep 2025 08:00:00 -0400

Joseph Mikhael, chief medical officer of The International Myeloma Foundation, and his organization are pulling all the stops to find a true cure for multiple myeloma, a rare and often fatal blood cancer. He shares the origins and mission of the Black Swan Research Initiative, a research project dedicated to preventing myeloma and finding a cure, and how global collaborators are contributing to multiple myeloma research. Also, host Deborah Borfitz delivers the latest news on ChatGPT determining trial eligibility, a questionable shortcut in rectal cancer drug trials, a new no-nausea weight loss remedy heading to trial, and more.

News Roundup

AI for stratifying Alzheimer’s patients

Study in Nature Communications

Questionable shortcut in rectal cancer drug trials

Investigation in JAMA Network Open

ChatGPT determines trial eligibility

Paper in Machine Learning: Health

Major trauma study to test hemorrhage treatment

News release by University of Colorado Anschutz Medical Campus

New weight loss remedy soon heads to trials

News on Syracuse University website
Study in Science Translational Medicine

Episode: 41 - How Non-Profits Are Filling Unique Roles in Clinical Research

Tue, 05 Aug 2025 07:00:00 -0400

Children’s Tumor Foundation CEO Annette Bakker discusses what non-profit organizations uniquely bring to clinical research and new financial models sustaining their contribution. Plus, host Deborah Borfitz rounds up the latest news in clinical research: new funding approaches for ALS clinical trials, spatial biology to match patients to trials, a bio map of lung cancer tumor changes, improving diabetes treatment outcomes for patients in China, and more.

Show Notes

News Roundup

Fund of Adaptive Royalties

Research article in PLOS One

TACIT algorithm matching patients to trials

Article in Nature Communications

Mapping biomarkers linked to treatment resistance

Press release on the City of Hope website

Pragmatic diabetes trial in China

Paper about China-specific genetic risk score in Diabetologia
News of trial launch on the University of Exeter website

Cough medicine to slow dementia?

Study in JAMA Neurology

Beating the EARL hurdles in the UK

Study in JAMA Network Open

Guest

Annette Bakker, Ph.D., CEO of the Children's Tumor Foundation

Article in Clinical Research News

Episode 40: The Advancement and Implementation of Pragmatic Trials

Tue, 08 Jul 2025 07:00:00 -0400

The latest on a trio of pragmatic trials for lung cancer treatment, the implementation of national-scale pharmacogenomic testing, an efficient approach to comparing commonly used intravenous fluids, improving access to gene therapy trials for a progressive heart condition, the landscape for Alzheimer’s disease studies, clinical trials that predict the most effective therapy, and the creation of AI agents for clinical research. Joining the discussion is Bethany Kwan, director of the Dissemination & Implementation Research Core at the Colorado Clinical & Translational Sciences Institute at the University of Colorado Anschutz Medical Campus, and Heather Smyth, research associate with the Center for Innovative Design and Analysis in the Colorado School of Public Health. They talk about the advancement of pragmatic clinical trials, how they differ from traditional studies, and how to handle the challenges that come with implementing them.

Episode: 39 - Blythe Adamson on Patient-Level Real-World Data for Multinational Oncology Research

Tue, 03 Jun 2025 07:00:00 -0400

In this episode of the Scope of Things, host Deborah Borfitz brings you the latest news on AI-recommended precision dosing, organoid drug testing aiding treatment selection for bowel cancer, an AI tool for stratifying lung cancer patients, using HIV drugs to treat Alzheimer’s disease, and the potential value of magic mushrooms to remedy the mood symptoms of Parkinson’s. Blythe Adamson, international head of outcomes research and evidence generation at Flatiron Health, also joins in to discuss groundbreaking work harmonizing patient-level real-world data across four countries to enable multinational oncology research.

News Roundup

CURATE.AI platform

Article in Clinical Research News
Study in npj Precision Oncology

FORECAST-2 clinical trial

News on the Walter and Eliza Hall Institute website

AI tool for sorting cancer patients

Study in Nature Communications

HIV drugs for Alzheimer’s protection

Study in Alzheimer’s & Dementia

“Magic mushrooms” for Parkinson’s disease

Study in Neuropsychopharmacology

Guest

Blythe Adamson, Ph.D., international head of outcomes research and evidence generation at Flatiron Health

Flatiron Health enabling multinational oncology researh – article in Bio-IT World

Subscribe to the podcast on Apple Podcasts and leave a review to support the show. Join us at Scope Europe on October 14-15 in Barcelona - use code SOT10 for an additional 10% discount.

GUEST BIO

Blythe Adamson, PhD, MPH, Head of Outcomes Research and Evidence Generation, International at Flatiron Health & Founder of Infectious Economics
Dr. Blythe Adamson is the head of international outcomes research and evidence generation at Flatiron Health.

As a visionary senior leader at Flatiron Health, her team pioneered deep learning language models for extraction of clinical details from EHR documents, breaking the limits of what was possible for humans to do alone. Learning from the experience of millions of patients with cancer, they generate evidence of treatment effectiveness and value used by governments around the world. Dr. Adamson co-invented a patented clinical decision-support tool, enabled by machine learning, that is used by cancer clinics to benefit patients.

She holds degrees in microbiology, epidemiology, and pharmaceutical economics with a focus on infectious disease prevention. Dr. Adamson has held roles at the Bill and Melinda Gates Foundation Institute for Disease Modeling, the NIAID HIV Vaccine Trials Network, and Flatiron Health.

Episode: 38 - Tackling the Misinformation Epidemic with Briony

Tue, 06 May 2025 08:00:00 -0400

In this episode of the Scope of Things, host Deborah Borfitz brings you the news on a precision medicine initiative in Sweden integrating research with healthcare, newly available cardiometabolic clinical data registries for real world evidence projects, updates to guidelines on the reporting of clinical trials, AI improving the monitoring of movement disorders, and the best-yet biomarker for stroke and dementia risk. Joining the conversation is Briony Swire-Thompson, director of the Psychology of Misinformation Lab at Northeastern University Network Science Institute, to discuss the current misinformation epidemic and how clinical trials and sites can best deal with it.

News Roundup

Precision Omics Initiative Sweden (PROMISE)

Correspondence in Nature Medicine
Article in Clinical Research News

Cardiometabolic clinical data registries

Article in Clinical Research News

New CONSORT reporting guidelines

Article in JAMA

VisionMD for analyzing motor function

Article in Nature

Best-yet biomarker for stroke and dementia risk

Article in Diagnostics World News

Episode: 37 - Using AI to Translate Clinical Trial Results with Ravi Parikh

Tue, 08 Apr 2025 11:00:00 -0400

In this episode of The Scope of Things, host Deborah Borfitz covers the latest news, including setting expectations for Phase II cancer trials, key learnings about dementia from the Nun Study, links between cardiovascular disease and mild cognitive impairment, using aspirin to prevent cancer spread, a clinical trial map to improve study access, and a naturally occurring molecule that rivals Ozempic in its weight loss potential. Deborah also speaks with Ravi Parikh, medical director of data and technology applications shared resource at Winship Cancer Institute of Emory University, about a novel AI platform he helped develop to translate clinical trial results to real world populations.

News Roundup

Phase 2 cancer drug trials

Study in the Journal of the National Cancer Institute

Nun Study insights

Review article in Alzheimer’s & Dementia

DORIAN GRAY project

Press release by the European Society of Cardiology

Aspirin for preventing cancer spread

Study in Nature

New clinical trial map

News announcement on the EMA website

Molecule rivaling Ozempic

Study in Nature

Episode: 36 - Wes Michael on Enhancing Patient Voices and Sharing Their Insights

Tue, 04 Mar 2025 09:00:00 -0500

In this episode of the Scope of Things, host Deborah Borfitz delivers the latest on an AI-powered trial screening tool that outperforms research staff, a strategy report on ways to boost cancer vaccine work, the continued absence of pregnant women in clinical trials, a program bringing studies directly to people in rural Utah, and efforts to integrate clinical trials into routine patient care in medically underserved areas of Oklahoma. Wes Michael, founder and president of Rare Patient Voice, also joins in to discuss how his company is connecting people undertaking research studies with participants eager to share their insights—and getting paid to do so.

News Roundup

AI clinical trial screening tool

Research letter in JAMA

Strategy report on cancer vaccines

Commentary in Cambridge Prisms: Precision Medicine

Exclusion of pregnant women from trials

Article in American Journal of Obstetrics and Gynecology

Bringing cancer care and trials to Utah’s rural residents

Press release on Huntsman Cancer Institute website

Integrating clinical research into primary care

News on OU Health Sciences website

Guest

Wes Michael, president and founder of Rare Patient Voice

Episode: 35 - SCOPE 2025, Participant Engagement Award Winners, How AI is Helping Trials, and More

Fri, 14 Feb 2025 07:00:00 -0500

In this episode of the Scope of Things, host Deborah Borfitz provides the latest on new criteria for defining and diagnosing obesity, the case for including pregnant women in vaccine trials, the subtyping of osteosarcoma, an inert gas being tested as an Alzheimer’s treatment, and more. Joining the conversation is David Sall, president and CEO of Patient Enrollment Advisors, who talks about the origins of the Participant Engagement Award at SCOPE 2025 and how the conversation around participant engagement has changed over time (and the changes that still need to happen). Finally, we have Allison Proffitt, editorial director of Clinical Research News, interviewing Trân Lê and Sohit Gatiganti, co-founders of Grove AI and the winners of the Participant Engagement Award at SCOPE 2025.

Episode: 34 - Ringing in 2025 With Validating Novel Digital Clinical Measures, Decentralized Trials, and More

Tue, 07 Jan 2025 08:00:00 -0500

In this episode of the Scope of Things, host Deborah Borfitz delivers the news on an investigation into data reporting problems in major Ticagrelor clinical trial PLATO, the need for more sex-aware cancer research, Alzheimer’s studies looking at brain shrinkage associated with immunotherapies (and repurposing drugs as potential new treatments), and a large, decentralized trial that successfully uncovered disease-causing genetic variants in hundreds of participants. Benjamin Vandendriessche, chief delivery officer of Digital Medicine Society, also joins in to talk about a newly completed project with the FDA that is providing guidance and resources on how to validate novel digital clinical measures.

News Roundup

PLATO trial investigation

Findings published in The BMJ

“OncoSexome” project

Paper in Nucleic Acids Research

Brain shrinkage with Alzheimer’s treatment

Research in The Lancet Neurology

Repurposing drugs for Alzheimer’s

Study in Alzheimer’s & Dementia

Mayo Clinic Tapestry study

Article in Mayo Clinic Proceedings

Guest

Benjamin Vandendriessche, chief delivery officer, Digital Medicine Society

Episode:33 - Orr Inbar Discusses Saving Costs and Complications With Clinical Trial Simulations

Tue, 10 Dec 2024 08:00:00 -0500

In this episode of the Scope of Things, host Deborah Borfitz covers concerns surrounding the study and treatment of obesity, a new “opening doors” initiative to clinical trials, debate over the European Union AI Act, the first international-level clinical study using secure multiparty computation, a hopeful treatment for kids with lethal brain tumors, and a ChatGPT tool created by the NIH to match potential volunteers to relevant studies. Joining the conversation is Orr Inbar, CEO and co-founder of QuantHealth, who discusses how his company is using AI to simulate clinical trials to alleviate costs and efficiency issues for the notoriously complicated drug development process. He also shares the proprietary tech powering QuantHealth’s AI and where he sees AI heading as 2025 unfolds.

News Roundup

Perspectives on the EU AI Act

Insights about the rollout in Clinical Research News
Article in Clinical Research News about discussion at SCOPE Europe

Secure multiparty computation

Article in Bio-IT World
Study in npj Digital Medicine

Cell therapy for childhood brain cancer

Study published in Nature
Stanford Medicine press release

TrialGPT tool

Study in Nature Communications

Episode: 32 - SCOPE Europe 2024, AI, New Cancer Treatments, More

Tue, 05 Nov 2024 07:00:00 -0500

In this episode of the Scope of Things, host Deborah Borfitz shares the latest news on a drug repurposing AI model now being tested in rare disease clinical trials, a new way forward for triple-negative breast cancer, Jill Pellegrino’s transition from CVS to AutoCruitment, incorporating placental pathology into perspective clinical trials, making ethical oversight of clinical trials more “fit-for-purpose,” and publication bias with industry sponsored studies for psychiatric drugs. We also have Allison Proffitt, editorial director of Clinical Research News, interviewing speakers at SCOPE Europe 2024 on how AI is being used for clinical trials, their pick for the 2024 rising star in the clinical research ecosystem, and the most hotly-debated topics in trial planning and execution.

SHOW NOTES

News Roundup

AI for drug repurposing

Study in Nature Medicine

Window trial for new breast cancer approach

Study in Science Advances
Article in Bio-IT World

Prescreening regimen of AutoCruitment

Article in Clinical Research News
Episode 12 guest appearance on podcast

Trials needing placental pathology

Opinion piece in Trends in Molecular Medicine

Fit-for-purpose ethical oversight

Special communication in JAMA

“Sponsorship effect” on psychiatric drug trials

Study in Journal of Political Economy

Guests
Nicole Stansbury, Head of Global Clinical Operations at Premier Research
Farrell Healion, Head of Emerging Technologies at AstraZeneca
Jonathan Crowther, Head of Predictive Analytics, PRD (OARS), Pfizer

Episode: 31 - Aaron Mackey on Trial Planning and How AI Can Help With Diversity

Tue, 01 Oct 2024 07:00:00 -0400

Tune in for the latest news and trends in this month’s episode of the Scope of Things, where host Deborah Borfitz covers everything you need to know about a pending launch of a large treatment trial for Graves’ disease, a recruitment campaign for a diagnostic tampon, Walgreens and BARDA’s new partnership, how eligibility criteria has been excluding people of African or Middle Eastern descent from cancer studies, and more. Joining the discussion is Aaron Mackey, vice president of AI and data science at Lokavant, who talks about the unintended consequences of decisions made during trial planning that can lead to questionable conclusions, how AI and ML are helping with the diversity issue in trial participation, and his stop gap emergency plan to keep trials on track if there is no digital support available.

SHOW NOTES

News Roundup

Phase 3 trial for Graves’ disease

Article in Clinical Research News

Quality of life measures in cancer studies

Study in Journal of Clinical Oncology
Article in Clinical Research News

Rapid recruitment for a diagnostic tampon trial

Article in Clinical Research News

Reference trial emulation

Study in PLOS Medicine

Walgreens/BARDA partnership

News brief in Clinical Research News

“Detective” algorithm for improving trial design

Study in Nature Genetics

Exclusion of people with Duffy-null phenotype

Study in JAMA Network Open

Episode: 30 - Shining the Spotlight on Rare Disease Trials With Uncommon Cures

Tue, 03 Sep 2024 07:00:00 -0400

This month’s episode of The Scope of Things features the latest trending news from host Deborah Borfitz, including a planned library of “nature’s drugs” targeting complex diseases, a paradoxical approach to treating cancer, how government policies can help improve equitable access to cancer trials, and the possibilities of reversing multiple sclerosis nerve damage. Marshall Summar, CEO of Uncommon Cures, and Tamanna Roshan Lal, Chief Medical Officer of Uncommon Cures, join the conversation to discuss how their organization is tackling the root causes of rare diseases trials that take too long and cost too much. They delve into the market interest behind rare disease trials and what Uncommon Cures is doing differently, as well as share the company’s international expansion plans and where they see this operationalized rare disease clinical trial paradigm in a few years.

SHOW NOTES

News Roundup

Pharmaceutical-grade HMOs

Article in Clinical Research News

Paradoxical cancer treatment approach

Study in Cancer Discovery
Article in Clinical Research News

Switching on the desire the exercise

Study in Science Advances

STEP stroke platform trial

Press release from the University of Cincinnati

Policy interventions to improve trial equity

Study in Journal of Clinical Oncology
Article in Clinical Research News

New drug for MS

Study in PNAS

Guests

CEO Marshall Summar, M.D., and CMO Tamanna Roshan Lal, M.D., with Uncommon Cures

Article in Clinical Research News

Episode 29 - Patient-Focused Drug Design, Enrollment Challenges, and More With Hannah Kemp

Tue, 06 Aug 2024 08:00:00 -0400

Tune into this month’s episode of the Scope of Things, where host Deborah Borfitz covers the use of AI for trial screening and recruitment purposes, a diabetes drug that may help treat sleep apnea, questionable advice from the FDA given to departing staffers, why the entire clinical trial enterprise may need to be revamped to eliminate systemic biases, and more. Hannah Kemp, vice president of strategic client engagement at Surgo Health, also joins the conversation to talk about how Surgo Health is helping companies recruit participants and her SCOPE 2024 presentation, as well as her thoughts on patient-focused drug design and the challenge of getting study sponsors on-board with enrollment strategies.

SHOW NOTES

News Roundup

AI for clinical trial screening

Study in NEJM AI

AI for trial recruitment

Study in Ophthalmology Science

Drug therapy for sleep apnea

Study in NEJM

Investigation on departing FDA employees

Article in The BMJ

N-Power Medicine/Merck collaboration

Press release

Youth prediabetes/diabetes dataset

Link to POND web portal

Systemic biases in randomized controlled trials

Study in Journal of Ethnicity in Substance Abuse

GUEST BIO

Hannah Kemp, vice president of strategic client engagement, Surgo Health

Hannah Kemp is the Vice President of Strategic Client Engagement at Surgo Health.

In her role, she helps clients develop more patient-centric healthcare and clinical trials leveraging Surgo’s novel data. Ms. Kemp has led large-scale projects across multiple therapeutic areas from infectious disease, maternal health, vaccines, and cancer and published. Ms. Kemp brings an ecosystem perspective having worked across healthcare from clinical trials to digital health to payors. Prior to joining Surgo, Ms. Kemp worked with Deloitte consulting as well as directly for the US government. She has a BA from the University of Virginia and an MPA from George Washington University.

Episode: 28 - Jonathan Kimmelman on Research Ethics and Dilemmas in Clinical Trials

Tue, 09 Jul 2024 08:00:00 -0400

In this month’s episode of the Scope of Things, host Deborah Borfitz gives you the latest news on the fallacy of a survival benefit for cancer patients participating in clinical trials, how and why federally qualified health centers are getting involved in studies, efforts to disrupt the current practice of excluding pregnant and lactating women from participation, great news about the impact of precision medicine on the outcomes of kids suffering from aggressive cancers, and more. Jonathan Kimmelman, PhD, Professor of Biomedical Ethics at McGill University, also joins Deborah to discuss current dilemmas in clinical development and how research standards are trending. Kimmelman talks about the ethical implications when trial sponsors don’t fully disclose how patient input is utilized in drug development, key policies that are necessary and would have a big impact on regulators, and what would-be participants can do to be more informed about trials.

SHOW NOTES

News Roundup

“Participation effect” not a benefit of cancer trials

Article in JAMA
Article in Annals of Internal Medicine

CARE for Health initiative of the NIH

Editorial in Science

Integration of clinical trials with healthcare delivery

Special communication in JAMA

FQHCs conducting clinical trials

Episode 21 with Javara Medical Director Colleen Purcell Tenan, M.D.

Factors influencing trial participation by pregnant and lactating women

Review in PLOS Medicine

Flicker stimulation for epilepsy

Study in Nature Communications

Precision medicine for kids with cancer

Article in Nature Medicine

GUEST BIO

Jonathan Kimmelman, PhD, James McGill Professor of Biomedical Ethics, McGill University

Jonathan Kimmelman, PhD, is James McGill Professor of Biomedical Ethics at McGill University. His research group, STREAM (Studies in Translation, Ethics and Medicine) uses empirical and theoretical methods to understand the ethical, policy, and scientific dynamics of developing new drugs. Kimmelman received the Maud Menten New Investigator Prize (2006), a CIHR New Investigator Award (2008), a Humboldt Bessel Award (2014), and was elected a Hastings Center Fellow (2018). He has sat on various advisory bodies within the

Episode: 27 - Yvonne Rodriguez on Making Clinical Trials Accessible for Everyone

Tue, 04 Jun 2024 08:00:00 -0400

In this episode of the Scope of Things, host Deborah Borfitz covers the latest news on an AI model for comparing drug effectiveness, adoption of minimal residual disease as an endpoint for multiple myeloma, using HIV treatments for Alzheimer’s disease, lack of diversity in Alzheimer’s trials, and more. Yvonne Rodriguez, founder and CEO of Egality Sciences, also joins the conversation to talk about breaking down the barriers to clinical research participation in underserved communities. She also delves into her personal story of what inspired her to start her company, how Egality Sciences is teaching physicians and staff at local hospitals to get and stay involved with industry-sponsored studies, and the challenges that need to be overcome to ensure that every patient has equal access to clinical trials as a treatment option.

SHOW NOTES

News Roundup

AI for predicting treatment outcomes

Article in Patterns

Minimal residual disease as an endpoint

FDA information package (multiple myeloma)

Window-of-opportunity clinical trials

Ontario Institute for Cancer Research webpage

HIV treatments for Alzheimer’s?

Proof-of-concept study in Pharmaceuticals

Implantable device for brain disorders

Study published in Science Advances
Motif Neurotech website

Lack of diversity in Alzheimer’s disease trials

Study about differences in plasma biomarker eligibility

OMB’s updated race/ethnicity standards

PDF of final recommendations

GUEST BIO

Yvonne Rodriguez, founder and CEO of Egality Sciences

Yvonne Rodriguez is the founder and CEO of Egality Sciences. Originally from Socorro, Texas, she started working on clinical trials after receiving her BBA from St. Mary’s University, in San Antonio, Texas. She brings over 20 years of clinical research industry experience having worked at clinical research sites, IRBs, CROs, and pharmaceutical and biomedical device companies. Prior to starting Egality Sciences, Yvonne worked at AstraZeneca and led projects in the DEI space that had successful results. Yvonne holds a Master’s of Science in Health Sciences from George Washington University, and has received a professional certificate from Oxford University.

Episode: 26 - Digital Twins, Care-For-All European Platform, and the Impact and Future of Wearables and Microsampling

Tue, 07 May 2024 07:00:00 -0400

In this episode of the Scope of Things, host Deborah Borfitz brings you the monthly breakdown on current events, such as tailoring medications to individual patients using digital twins, the use of a skin biopsy test to diagnose neurodegenerative diseases, and the launch of a European-wide platform promoting access to care for all. She also speaks with Michael Snyder, chair of the department of genetics at Stanford University School of Medicine and director of the Center of Genomics and Personalized Medicine at Stanford, about the growing adoption of wearables and home microsampling—and how this will dramatically change clinical trials and care. Snyder also delves into the “Amazon-ing” of healthcare and how he envisions the creation and future of personalized metrics and customized interventions and how they can improve trial outcomes.

Show Notes

News Roundup

Probabilistic approach to diagnosing cancer

Story in Clinical Research News

Functional precision medicine

Pediatric study in Nature Medicine

Cancer clinical trial access

JAMA Oncology article on new recruitment approach

Endpoints in cancer screening trials

Comparative study in JAMA

Rate of participation in cancer research

Study in Journal of Clinical Oncology

Tailoring medications with digital twins

Article in Genome Medicine

Skin biopsy test for neurodegenratve diseases

Study in JAMA

European Patient Observatory

Initiatives encourging innovation

GUEST BIO

Michael Snyder, Ph.D., chair of the department of genetics at Stanford University School of Medicine and director of the Center of Genomics and Personalized Medicine at Stanford

As a pioneer of Precision Medicine, Dr Michael Snyder has invented many technologies enabling the 21st century of healthcare including systems biology, RNA sequencing, and protein chip. Dr Snyder has initiated the Big Data approach to healthcare through his work using omics to detect early stage disease, including wearables to detect infectious diseases like COVID-19, and at-home microsampling to measure hundreds of molecules from a single drop of blood. He is the first researcher to gather petabytes of data on individuals, which is 1 million - 1 trillion times more data than the average clinician collects. He as published over 800 papers and is one of the most cited scientists. In terms of c

Episode: 25 - The Missing Link in Clinical Trials and Brain Monitoring: Consistent EEG Use

Tue, 02 Apr 2024 07:00:00 -0400

In this month’s episode of the Scope of Things, host Deborah Borfitz covers the latest news and emerging trends, including the launch of a company using single-solution software to connect a global network of clinical trial sites to study sponsors, a pharmacy-first program in the UK, a centralized staffing initiative at the National Cancer Institute, progress in getting patient-derived organoids into clinical trials to evaluate drug response, and more. She also speaks with Lifelines Neuro’s chief scientific officer Dona Murphey, M.D., Ph.D. about shortcomings in the way EEGs are being use in clinical trials to monitor participants with potential brain damage, how EEG monitoring should be used in clinical research, and what the FDA has to say about all of this.

Show Notes

News Roundup

Launch of Pi Health

Business Wire news release

Pharmacy First initiative in the UK

National Health Service announcement
Story on Walgreens’ clinical trials business

Pediatric rare disease research

Article in Hepatology about utility of real-world cohort

NCI Virtual Clinical Trials Office

Announcement on the NCI website

Precision oncology clinical trial landscape

Novotech whitepaper

Translational Research Innovation Program

Announcement by IRB Barcelona

Patient-derived organoids in clinical trials

Study in Cells Tissues Organs

GUEST BIO

Dona Murphey, M.D., Ph.D., chief scientific officer for Lifelines Neuro

Dona is a neurologist, neuroscientist, historian of science, and community health worker educated at Harvard and Baylor College of Medicine. She currently serves as principal consultant at In Phase Neuro and fractional chief scientific officer at Synthesys Brain Health (a joint endeavor between Lifelines Neuro and Neurovative Diagnostics), specializing in the area of EEG in clinical trials.

Episode: 24 - SCOPE 2024, AI Innovation, and Pitch Contest Winner Dezbee McDaniel

Tue, 05 Mar 2024 08:00:00 -0500

In this month’s episode of the Scope of Things, host Deborah Borfitz catches listeners up with the latest news of the clinical trials and research industry, starting with SCOPE 2024, where a record-breaking 4,000 attendees arrived to learn and discuss about new products, technology, and ideas. Other hot topics in this episode include convergence of clinical research and clinical care, patient centricity, protocol complexity, the growing use of AI, and an update on decentralized clinical trials. She also interviews CliniSpan Health founder and CEO Dezbee McDaniel, winner of the pitch contest at SCOPE, about his company’s novel social media influencer relationship management platform for improving clinical research diversity.

LINKS

Summit for Clinical Ops Executives (SCOPE)

Conference website

Convergence of clinical research and clinical care

Story in Clinical Research News [link to come, story runs 2/27?]

Oliver Patch Project

Website

Conference themes

ProofPilot integrates Magnol.AI

Press release

TransCelerate’s Participant Data Return initiative

Resource pack

Impact of protocol design on trial performance

Study in Therapeutic Innovation & Regulatory Science

Use of AI in clinical development

FDA-issued discussion paper

Episode: 23 - Discussing Review Boards, Social Media, and World Events With Donna Dorozinsky

Tue, 06 Feb 2024 11:00:00 -0500

In this episode of The Scope of Things, host Deborah Borfitz provides a rundown of the latest news in the clinical trials field: a massive health research initiative in the UK, widespread overdosing of trial participants, a cholesterol-lowering vaccine, the growing popularity of phage therapy, a novel scoring mechanism for de-risking trials for chronic diseases, a strategy for making staph vaccines a reality, and the latest oral drugs heading to trials that could eliminate one of the chief barriers to insulin therapy for diabetics. Deborah also speaks with Donna Dorozinsky, President & CEO of Just in Time GCP, about recent changes related to expectations of institutional review boards, the use of social media for recruitment and communication purposes, and the impact of world events on clinical data management.

News Roundup

Our Future Health

Program website

Medication adherence crisis

Cholesterol-lowering vaccine

Phage therapy

Pharmagenic enrichment score

Staph vaccine trials

Cell Reports Medicine paper on immune imprinting informing vaccine development

New oral insulin drug

Nature Nanotechnology paper on the formulation with reduced episodes of hypoglycaemia

Guest

Episode: 22 - Clinical News, Start-Ups, and More With Ward Lemaire and Dan Hydes

Tue, 09 Jan 2024 07:00:00 -0500

New Year, new podcast format! In 2024’s first episode of the Scope of Things, host Deborah Borfitz gives you the latest news from the clinical trials industry, including AI’s role in the creation of digital twins, the obesity epidemic and the drugs intended to combat it, improving diversity in trial candidates, and more. We also have expert advice from Ward Lemaire, VP Head of Data Management and Central Monitoring at J&J Innovative Medicine, and Dan Hydes, Co-Founder and CEO at IgniteData, on SCOPE’s new Startup Pitch Competiton, and how start-up companies can meet multiple demands and needs, direct their limited resources, and keep the innovation train going.

New Advisory Board

News Roundup

AI and Chatbots

Digital Twins

Pan-European project simulating stroke treatments

Obesity Clinical Trials

New areas of interest

Pharmacy Research Organization RxE2

Platform for independent community pharmacists launches

Episode: 21 - Colleen Purcell Tenan on Providing Patients With Clinical Research Care Options

Tue, 05 Dec 2023 06:00:00 -0500

Can clinical trials be a helpful treatment option for patients? In this episode of The Scope of Things, host Deborah Borfitz speaks with Colleen Purcell Tenan, MD, Medical Director at Javara, about providing clinical research as a care option for patients. Tenan talks about the benefits of receiving clinical research care from one’s own physician, Javara’s process of matching patients with the right healthcare system for clinical trials, and how Javara supports providers who haven’t done sponsor research before. She also shares her thoughts on where decentralized trial components best fit in clinical studies in a post-pandemic world and using remote technologies for convenient medical care and research.

Scope of Things Links:
Clinical Research News
Scope Summit

Javara Links:
Javara

Episode: 20 - Michael Ibara on Changing the Clinical Trial Process for AI Application

Tue, 07 Nov 2023 07:00:00 -0500

There are concerns surrounding the uses of AI in clinical trials, particularly on the regulations side. In this episode of the Scope of Things, host Deborah Borfitz discusses with Michael Ibara, Pharm.D., Chief Data Officer at Elligo, about the roadblocks and challenges obstructing AI’s potential in clinical trials. Ibara also talks about his perspective on the necessary changes to the clinical trial process to further apply AI, why innovation is a key factor, and what can be done in terms of regulations both domestically and internationally. He also shares his experiences with building a better system of organizing and processing EHR data with the Astra Project.

Episode:19 - Tackling The Complex Process Of Vendor Selection With Dennis Salotti

Tue, 10 Oct 2023 07:00:00 -0400

Selecting a vendor to do business with can be a tricky, convoluted process. How do you know who is the right fit? In this episode of the Scope of Things podcast, host Deborah Borfitz speaks with Dennis Salotti, Executive Director & Head, Clinical Outsourcing & Innovation at Jazz Pharmaceuticals, who shares what he knows about the complex vendor qualification process and the various ways sponsors and CROs are going about the expensive and time-consuming exercise. With two decades of experience in the field and having co-authored a report with Tuft’s Center for the Study of Drug Development, Salotti provides valuable insight on what to prioritize during vendor assessment, what factors can affect customized assessments, and the importance of building—and sometimes rebuilding—relationships with vendors. He also delves into how effective internal data and precompetitive info sharing on routinely assessed areas can help reduce cycle time and how companies can act on this.

Links from this episode:

Scope of Things Links:
Clinical Research News
Scope Summit

Jazz Pharmaceuticals:
Jazz Pharmaceuticals

Episode: 18 - The Clinical Reality of Chronic Wounds

Tue, 05 Sep 2023 07:00:00 -0400

What can be done to improve clinical trials for patients with chronic wounds? In this new episode of the Scope of Things, host Deborah Borfitz speaks with Dr. Caroline Fife, world-renowned wound care physician and Chief Medical Officer at Intellicure, about the clinical realities of chronic wounds and wound treatment. Dr. Fife shares her thoughts on the “sorry state” of clinical trials for wound care products and what she has learned as the Executive Director of the U.S. Wound Registry that shed some light on the matter. She also discusses how her first clinical trial sparked her drive to improve conditions and the barriers that prevent innovation in the development of new products and technology.

Links from this episode:
Clinical Research News
Scope Summit
Intellicure

Episode: 17 - How Retail Pharmacies Are Taking on Clinical Trials

Tue, 08 Aug 2023 07:00:00 -0400

What role do retail pharmacies have in research studies? In this episode of the Scope of Things, host Deborah Borfitz speaks with Ramita Tandon, Chief Clinical Trials Officer at Walgreens. Tandon discusses how retail pharmacies can play an important role in increasing access and retention in sponsor-lead drug development research. She also shares the specific approaches Walgreens is adopting in the US that have been gaining traction. Finally, she talks about why it is important to begin diversity and inclusion planning early in the drug development process and how it can allow researchers to think more holistically through the phases of clinical trials.

Scope of Things Links:
Clinical Research News
Scope Summit

Walgreens Links:
Walgreens

Episode: 16 - Advancing Diversity in Clinical Development

Tue, 11 Jul 2023 06:00:00 -0400

In this episode of The Scope of Things, Deb Borfitz speaks with Murray Aitken, Executive Director of the IQVIA Institute, about diversity in clinical development, DEI methods that are and are not working, and the impact diversity has on clinical trials. Aitken also discusses FDA-issued policies to advance diversity and efforts to reduce disparities between subpopulations. He also talks about factors that contribute to those disparities, such as socio-economic backgrounds, genetics, and trust in the system. Finally, he delves into the importance of having diverse groups of participants—particularly Black and Hispanic Americans—in clinical trials to ensure that patients receive the best treatment options and healthcare access.

Links from this episode:
Clinical Research News
Scope Summit
IQVIA Institute

Episode 15 - In the Clinic: Second Wave Biomarker Tests for Osteoarthritis

Tue, 06 Jun 2023 06:00:00 -0400

Years after serving in the Vietnam War, Virginia Byers Kraus’s father had his hip replaced—three different times. Each time, she said, outcomes were worse. Joint replacement is often the result of osteoarthritis, a degenerative joint disease commonly known as “wear and tear” arthritis. There are no disease-modifying drugs for osteoarthritis and early diagnosis is difficult. But even though the CDC estimates that nearly one in four people in the United States has osteoarthritis, Kraus rejects that idea that the disease—and resulting pain and surgical treatment—is inevitable. Her group at Duke is developing a proteomic panel of biomarkers that will be able to identify people with active disease before the evidence is visible on an MRI or X-ray.

Scope of Things Links:
Clinical Research News
Scope Summit Europe

Episode: 14 - Ardy Arianpour on Seqster’s Patient-Centered Healthcare Movement

Tue, 02 May 2023 06:00:00 -0400

When Seqster was first founded in 2016, co-founder Ardy Arianpour had a lot of experience in next-gen sequencing and a vision for how consumers could control their health information. Arianpour envisioned a place where anyone can bring all their health data together in one place and share it on their terms. Since then, Arianpour says he has found many parts of the business challenging. There have been shifts in the business model over time, which began as direct-to-consumer. He credits Seqster’s 2020 agreement with Takeda Pharmaceuticals as a tipping point. Now, with several pharma partnerships to boast, Seqster is more than a company, Arianpour insists to host, Deborah Borfitz, in the latest Scope of Things podcast. “This is a movement.”

Links from this episode:
Seqster’s Perfect Timing, Powerful Platform Might Change Health
Clinical Research News
Seqster

Episode: 13 - Dr. Su Golder on Reporting Adverse Events in Clinical Research

Tue, 04 Apr 2023 06:00:00 -0400

Dr. Su Golder, associate professor and senior research fellow in the Department of Health Sciences at the University of York, has dedicated a significant portion of her career to improving the reporting of adverse events in clinical research. In this episode, she speaks with host Deborah Borfitz about why adverse events are vital to address but often difficult to ascertain for any given therapeutic intervention.

Golder talks about the strategic ways data can be manipulated—often leading to underreporting or misleading reporting—and the preferred guidelines that help researchers relay accurate information to clinicians and patients. She also discusses why data from randomized controlled trials are not always the best indicator of adverse advents in the real world and why social media provides valuable insights into why patients discontinue drug usage even when symptoms are considered minor. She says, “If something stops a patient from taking [a drug], then it doesn’t matter how effective [that drug] is. So [patient experience] is the most important thing.”

Links from this episode:
Clinical Research News
University of York
Adverse Event Reporting May Need A Total Redo
Medicines & Healthcare products Regulatory Agency Yellow Card reporting
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)
PRISMA harms checklist: improving harms reporting in systematic reviews
Consolidated Standards of Reporting Trials (CONSORT)
OpenTrials: towards a collaborative open database of all available information on all clinical trials
Cochrane Adverse Effects Methods Group

Episode: 12 - Jill Pellegrino of CVS Health Clinical Trial Services on Using RWE to Improve Clinical Trial Efficiency and Applicability

Tue, 07 Mar 2023 06:00:00 -0500

In 2020, retail pharmacy giant CVS launched CVS Health Clinical Trial Services in response to the COVID-19 pandemic. They aimed to increase patient recruitment and encourage equitable participation in clinical research to accelerate COVID trials. In this episode, Jill Pellegrino, vice president of recruitment and RWE at CVS Health Clinical Trial Services, speaks with host Deborah Borfitz about CVS’ service offerings and its collaborative work to improve the efficiency and applicability of clinical trials beyond vaccines.

Pellegrino discusses how the company secured nearly 33,000 clinical trial participants in just two years and their work with pharmaceutical companies to understand patient behaviors and drive positive behavioral change through real-world evidence. She also talks about their cohesive data set of “100 million lives” and how the business works seamlessly with CVS’ MinuteClinics to execute pragmatic trials. Finally, she discusses the company’s goal to expand into multiple therapeutic areas—including oncology trials—and partner with Aetna to access a new potential patient base.

Links from this episode:
Clinical Research News
CVS Health
CVS Health Clinical Trial Services
CVS MinuteClinic

Episode: 11 - Dr. Graham Hatfull on the Benefits of Phage Therapy and the Future of Phage Clinical Trials

Tue, 07 Feb 2023 07:00:00 -0500

Healthcare professionals are searching for new ways to fight bacterial infections as growing concerns around antibiotic resistance reach new heights. Though bacteriophages or phages—viruses that infect only bacteria—have long since captured scientists’ attention, they are quickly gaining popularity as a new and promising therapeutic tool. In this episode, Graham Hatfull, professor of biological sciences at the University of Pittsburgh, speaks with host Deborah Borfitz about his team’s research and diligent work to showcase phages as versatile therapeutic agents.

Hatfull also talks about the impressive findings produced by experimental phage therapy clinical trials and the barriers that currently prevent phages from ubiquitous antibacterial clinical use. He discusses his team’s efforts to sequence phages and build a therapeutic library, the role of phage therapy in combating tuberculosis and cystic fibrosis, and the novel benefits phages bring to transplant recipients. Hatfull also addresses the FDA’s support of phage therapy through expanded access for compassionate use and the global push to enter phages into their first-ever randomized controlled trial.

Links from this episode:
Clinical Research Newz
University of Pittsburgh
Phage Therapy of Mycobacterium Infections: Compassionate Use of Phages in 20 Patients With Drug-Resistant Mycobacterial Disease
SEA-PHAGES (Science Education Alliance-Phage Hunters Advancing Genomics and Evolutionary Science)
FDA Expanded Access for Compassionate Use
Phage Australia

Episode: 10 - Abbvie’s Christopher Boone on Disrupting the Clinical Research Enterprise

Tue, 03 Jan 2023 08:00:00 -0500

A self-described “data hippie,” Christopher Boone, vice president and global head of health economics and outcomes research at AbbVie, knows a great deal about using real-world data and generating real-world evidence in clinical trials. Boone sits with host Deborah Borfitz to talk about the disruptive presence of real-world evidence within the clinical trial enterprise and how it encourages researchers to reimagine trial design from start to finish. He says, “Much of the data we care about is captured outside the walls of the provider environment… Now, with all the digital technology, you can really understand the [patient’s] environment and experience in real-time.”

Boone assesses how effective the industry has been in democratizing data, how the 21st Century Cures Act was “probably the single biggest catalyst” in the expansion of real-world data, the industry’s transition to patient-centered research, and the systemic and cultural barriers challenging clinical studies today. He also shares tidbits from his upcoming talk at SCOPE Summit 2023 in early February.

Links from this episode:
Clinical Research News
AbbVie
21st Century Cures Act
Patient-Centered Outcomes Research Institute (PCORI)
PCORnet
SCOPE Summit

Episode: 09 - Dr. Loaiza-Bonilla on Massive Bio’s Efforts to Make Clinical Trials More Accessible for Cancer Patients

Tue, 06 Dec 2022 07:00:00 -0500

Dr. Loaiza-Bonilla details the importance of equity in increasing access to medical care, the reignition of the National Cancer Institute’s Cancer Moonshot program, and the U.S. Food and Drug Administration’s intention to standardize eligibility criteria. He also talks about the Massive Bio platform that could, one day, deliver medication via drones or offer at-home phlebotomy services to assist cancer patients from start to finish. He says, “My dream is that if a patient is unfortunately diagnosed with cancer, they can say, ‘Hey Siri or Cortana, help me find a clinical trial,’ and then the system does an e-consent, gets the records… screens them, and in 17 seconds you have the options. Then, [we get] them to the finish line.”

inks from this episode:
Clinical Research News
Massive Bio
US National Library of Medicine: Clinical Trials
Cancer Moonshot Program
A New Approach to Simplifying and Harmonizing Cancer Clinical Trials-Standardizing Eligibility Criteria

Episode: 08 - Janssen’s Jason LaRoche on Reducing Greenhouse Gas Emissions and the Environmental Impact of Clinical Trials0z

Tue, 01 Nov 2022 06:00:00 -0400

Jason LaRoche, Director of Clinical Innovation at Janssen Pharmaceuticals, speaks with host Deborah Borfitz about the global efforts launched to shrink the carbon footprint in the clinical trial and healthcare spaces. “If the global healthcare sector were a country, it would be the fifth largest emitter of greenhouse gases, and clinical research is a contributor,” explains LaRoche.

In this episode, LaRoche discusses the pre-competitive space designed to inventory individual trials and their greenhouse gas (GHG) emissions to predict the total GHGs for future studies. He also talks about the semi-public database created to share GHG findings across the industry, how regulators and research organizations worldwide are taking action to diminish their carbon footprint, and the standalone project he developed to significantly reduce the massive waste generated from wearable health devices.

Links from this episode:
Clinical Research News
Janssen Global
Sustainable Healthcare Coalition
The Pistoia Alliance

Episode: 07 - University College London’s Dr. Anna David on Increasing the Representation of Pregnant Patients in Clinical Trials

Tue, 04 Oct 2022 06:00:00 -0400

Pregnant women have consistently been underrepresented in clinical trials. With pregnancy studies posing significant risks to the mother and fetus, requiring extensive follow-up procedures, and potentially jeopardizing market approvals, many pharmaceutical companies avoid this demographic almost entirely. As a result, healthcare providers often struggle to access data regarding drug safety in pregnancy, preventing them from administering the best care possible. “Pregnant people make decisions in a vacuum of evidence. Very often, their healthcare providers don’t know the evidence, so the women actually make the decision and take the risk that everyone else is ignoring. I think that has to stop,” says podcast guest Dr. Anna David, obstetrician and director of the University College London Institute for Women's Health.

In this episode, host Deborah Borfitz speaks with David about the obstacles facing pregnant patients in today’s medical landscape and the past and present strides made to increase their representation in clinical research. David also talks about her work creating the first standardized vocabulary for drug safety and maternal-fetal adverse events, how COVID-19 changed the industry’s perspective regarding pregnancy studies, and the novel trials currently fostering change across the globe.

Links from this episode:

Clinical Research News
University College London
UCL EGA Institute for Women's Health
Innovative Medicines Initiative ConcePTION Project
Accelerating Innovation for Mothers
International Council for Harmonisation
Healthy Mum, Healthy Baby, Healthy Future
Paediatric Investigation Plan (PIP)
Maternal and Fetal Adverse Event Terminology

Episode 06: RxE2 Founder and CEO Gerald Finken on the Role and Value of Pharmacists in Clinical Research

Tue, 06 Sep 2022 06:00:00 -0400

Pharmacists demonstrate tremendous expertise in drug counseling and dispensation, so it seems undeniable that they should play a prominent role in clinical research. Surprisingly, their skill sets are rarely used in clinical trials. That’s why Founder and CEO Gerald Finken created RxE2, a community-based decentralized trial technology company spearheaded by pharmacists, offering primary stakeholders their rightful seat at the clinical research table.

In this episode, host Deborah Borfitz speaks with Finken about the challenges of delivering a new clinical trial concept and how the industry could benefit if pharmacists had more influence. He says, “I firmly believe that if pharmacists were involved, some of the issues that we’re having today in clinical trials wouldn’t exist. I don’t think recruitment would be a problem. I don’t think adherence and compliance would be a problem because pharmacists are medication experts who are trained to counsel patients and find out things real-time.” Finken also talks about the industry’s response to his new venture and the company’s plans to scale in the future.

Links from this episode:
Clinical Research News
RxE2
American Pharmacists Association
American Association of Pharmaceutical Scientists

Episode 05: Dipak Kalra on Effective Data and Knowledge Sharing Through Research Data Networks

Tue, 02 Aug 2022 06:00:00 -0400

Real-world data certainly plays a substantial role in understanding human health and disease. However, scientists find it increasingly difficult to extract research-specific data from massive unstructured and uncoded data sets. “What we are seeing now is a more proactive anticipatory mission to connect multiple repositories of health data and to enable a strongly de-identified, but fully anonymized, data set to be available for research questions,” Dipak Kalra, President of The European Institute for Innovation through Health Data, tells host Deborah Borfitz.

In this episode, Kalra speaks about the rise of research data networks and the facilitation of more effective and affordable research. He provides details about the growing challenges facing research teams and the new regulations imposed by the European Commission. Finally, Kalra shares his thoughts on how COVID changed the public’s perception of health data and encouraged quick and innovative knowledge sharing. “The pandemic is a situation from which we can learn and on which we must build because we would be negligent if we don’t,” warns Kalra. “The pandemic has shown how important it is to learn from big data in near to real-time in a way that absolutely transcends country boundaries.”

Links from this episode:
Clinical Research News
The European Institute for Innovation through Health Data
General Data Protection Regulation (GDPR)
European Health Data Space

Episode 04: How the World’s First Clinical Trial Market Network Saves Stakeholders Time and Money

Tue, 12 Jul 2022 07:00:00 -0400

ClinEco–a clinical trial ecosystem and market network designed to streamline the process of identifying and selecting clinical trial partners–is the first of its kind. Co-founders Dr. Marina Filshtinsky, SVP of Strategy and Product Development, and Micah Lieberman, VP of Community and Business Development, speak with Deborah Borfitz, Clinical Research News senior writer and podcast host, about the new platform's aim to revolutionize the way stakeholders navigate the clinical trial space. ClinEco reduces costs and increases study speeds by eliminating inefficiencies. “Identifying, validating, and contacting vendors and partners for clinical trials is a well-known bottleneck. The process is time-consuming, labor-intensive, inefficient, and expensive,” explains Filshtinsky. Hear the founders speak about creating a feature-rich platform that adds value over time and their goals for the network’s launch and beyond.

Links from this episode:

Clinical Research News
ClinEco
SCOPE: Summit for Clinical Ops Executives
New Study from Tufts Center for the Study of Drug Development Establishes Benchmarks for Vendor Qualification Process
Barrett International: Leaders in Clinical Research Training
World’s First Clinical Trials Ecosystem and Marketplace About To Open

Episode: 03 - Jasmine Smith and Dr. Deborah Duong on the First Decentralized AI Longevity Research Network

Tue, 07 Jun 2022 06:00:00 -0400

Jasmine Smith, CEO, and Dr. Deborah Duong, CTO, of Rejuve.AI help patients achieve a healthy and extended life expectancy regardless of economic standing. Rejuve is the world’s first decentralized AI longevity research network that provides equitable health and wellness solutions. The platform focuses on treatment accessibility, patient-centric research, data ownership, and fair labor. It also operates as an economy of clinical data researchers and contributors who retain ownership of their work. Contributors provide data and Rejuve's blockchain serves as a distributed ledger to keep patient data safe, ensure transparent data transactions, and maintain clear data ownership.

Links from this episode:
Clinical Research News
Rejuve.AI
PharmaLedger Project

Episode: 02 - Ken Getz’s Data-Driven Approach to Patient Engagement

Tue, 03 May 2022 07:00:00 -0400

Ken Getz and Clinical Research News Senior Science Writer, Deborah Borfitz, explore patient engagement. Getz, Executive Director & Research Professor at the Tufts Center for the Study of Drug Development (CSDD), shares what research has revealed about patient engagement efforts, where we’re stuck in a rut, a crucial misalignment in the industry’s view of patient engagement, and what clinical research participants actually want.

Scope of Things Links:
Tufts Center for the Study of Drug Development
Clinical Research News
Scope Summit

Episode: 001 - Craig Lipset Gets Real on our Decentralized Trials Future

Tue, 05 Apr 2022 07:00:00 -0400

The pandemic has certainly been a turning point for decentralized trials, and Craig Lipset, co-chair of the Decentralized Trials and Research Alliance (DTRA) says the reasons are clear: the industry’s risk balance has changed, he tells Deborah Borfitz, Clinical Research News senior writer and host of the new Scope of Things podcast. Now decentralized approaches to trials have become counter measures to the risky pandemic when patients couldn’t travel to sites. “Decentralized” is an umbrella term, Lipset explains, that encompasses both processes and technology—not just a lot of tech. A decentralized approach will impact how and where people participate, prioritizing flexibility, diversity, and expanding accessible geographies.

Episode: 000 - Introducing The Scope of Things

Mon, 28 Mar 2022 16:00:00 -0400

The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News Senior Writer welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.