
WCG Talks Trials
WCG
Insights from leaders in clinical research and trial optimization, hosted by the WCG Clinical.
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Top 10 WCG Talks Trials Episodes
Goodpods has curated a list of the 10 best WCG Talks Trials episodes, ranked by the number of listens and likes each episode have garnered from our listeners. If you are listening to WCG Talks Trials for the first time, there's no better place to start than with one of these standout episodes. If you are a fan of the show, vote for your favorite WCG Talks Trials episode by adding your comments to the episode page.

WCG's IRB Policy Change: Harmonizing Consent (Part 2)
WCG Talks Trials
02/27/24 • 8 min
In Part 2 of this discussion, Currien MacDonald, MD, CIP Medical Chair Director for WCG's IRB, discusses new FDA regulations for waiver of consent with Kelly Fitzgerald, PhD, WCG's IRB Executive Chair and VP IBC Affairs.

Amplifying Patient Voices to Advance Clinical Research: The Importance of Patient Advocacy
WCG Talks Trials
11/13/23 • 29 min
Listen to the latest episode of WCG Talks Trials to hear from experts on the importance of patient advocacy in clinical research and key takeaways from WCG's 2023 Patient Forum. We'll summarize how the patient forum elevates the voices of those changing drug development for the better and recap breakthroughs and best practices shared during the most recent event.
Discover more about patient and researcher collaboration, expanding diversity, equity, and inclusion in trials, and the latest advocacy-driven technology, science, and policy breakthroughs leading to modernized clinical research.
Guests:
- Desiree Underwood-Williams, PMP, CLSSBB, Director, Project Management Office, WCG
- Steve Smith, President, Patient Advocacy, WCG

Biostatistics and Biomarkers for the Reliability and Efficiency of Clinical Trials: A Conversation with Dr. Janet Wittes
WCG Talks Trials
02/13/20 • 15 min
In this episode, Dr. Janet Wittes, Founder and President of WCG Statistics Collaborative sits down with WCG’s President of Patient Advocacy, Steve Smith. Their conversation focuses on the importance of reliability and efficiency in clinical trials, and how biostatisticians work closely with clinicians and patients to help ensure clear results from trials. Moreover, they dive into how biomarkers can serve as surrogate endpoints for a trial, especially in the case of rare disease studies.

02/10/20 • 17 min
In this episode, WCG’s President of Patient Advocacy, Steve Smith, interviews Dr. Jeffrey Cooper, MD, MMM, Vice President of Process & Strategic Improvement at WCG, expert in the conduct of clinical trials, and Parkinson’s patient himself. During their conversation, Steve and Dr. Cooper highlight the strides clinical research has made for many therapeutic areas and the promise research has for individuals across the globe. With a specific focus on Parkinson’s disease, Dr. Cooper dives into his journey as a clinical trial participant and shares his experience on finding a trial, getting enrolled into the study, and his time spent throughout the trial.

Connecting Patients to Trials: Bernadette Siddiqi of The Michael J. Fox Foundation for Parkinson’s Research
WCG Talks Trials
12/16/20 • 12 min
Bernadette Siddiqi, associate director of research partnerships at The Michael J. Fox Foundation for Parkinson’s Research talks about how they give members of the public access to the Fox Trial Finder. This clinical trial search tool that allows anyone to search for Parkinson’s disease clinical trials. More than 300 are listed on the site.
It’s a bottleneck in clinical research. Patients are eager for a cure, but it can be difficult for them to connect to trials and for researchers to connect to volunteers.
Bernadette speaks of why it is critical to the foundation’s mission to provide an easy way to make this connection. Just as important, she says, is educating people about research. Fox Trial Finder provides both. Roughly 700 people visit the site each month.
The Michael J. Fox Foundation for Parkinson’s Research is dedicated to finding a cure for Parkinson’s disease through an aggressively funded research agenda.

On the Future of Movement Disorder Trials: Part 4 of WCG’s Transforming CNS Trials Series
WCG Talks Trials
10/21/20 • 9 min
Movement disorder trials have always been demanding. Now, sponsors face an additional challenge: How do you ensure data integrity in the era of remote clinical trials? In this podcast, Bob Dagher, MD, WCG MedAvante-ProPhase’s Chief Medical Officer, addresses this in conversation with Steve Smith, WCG President of Patient Advocacy. This is the fourth episode in our series, “Transforming CNS Trials During COVID-19—and Beyond.”
Sponsors planning to restart movement disorder programs need to be clear-eyed and realistic, Dagher counsels. “When it comes to remote assessments, we have to be vigilant and aware of what we can do and also about what we really cannot do.” Some assessments simply cannot be performed remotely. This means sponsors will need to figure out how to account for variability and missing data in their statistical plan before locking the database.
FDA guidance on the conduct of trials during COVID-19 helps provide a roadmap. For example, in the case of anticipated missing data the guidance clearly states to capture specific information in the case report form that explains the relationship to COVID-19.
But it also requires in-depth scientific and clinically-informed knowledge so that the quality of the data captured isn’t sacrificed as direct result. Accordingly, WCG has been working with clients to tailor remote assessments for sponsors’ trials, yielding assessments that are as close as possible to the in-person versions (minus those particular items that cannot be done remotely).
Dagher’s message? “Ensuring data integrity at every step of the process should be the primary guide for any decision-making process when deciding to restart your study.”
Prior to joining WCG MA-PP, Dr. Dagher, was the Chief Medical Officer of Cadent Therapeutics in Cambridge, Mass. Before that, he served in many leadership roles at small and large biopharmaceutical and clinical research organizations, including GlaxoSmithKline, Genzyme, Sanofi and Covance, among others. Dr. Dagher has fostered the development of multiple products in different indications and development platforms and advanced several small molecules and biologics across all stages of clinical development. His background includes therapeutic experience in psychiatry, neurology and rare diseases.

We Should Not Be Surprised: COVID-19 Disparities Lay Bare What’s Been There All Along
WCG Talks Trials
04/17/20 • 22 min
In this episode, former Assistant FDA Commissioner Jonca Bull, MD, discusses racial disparities in healthcare, how COVID-19 has made them impossible to ignore, and how this highlights the need for diversity in clinical trials.
Low-income minority communities are being hit disproportionately hard by COVID-19. Dr. Bull isn’t surprised: The current crisis has simply magnified existing disparities. A multitude of factors are at play, including lack of access to healthcare and healthful food. As a result of these and other issues, certain underlying health conditions are more prevalent in low-income minority communities.
Clinical trials must include these populations so we can truly understand COVID-19 and how to treat it in real-world conditions.
In fact, the FDA has long had guidance on how to make trials more diverse:
- Collection of Race and Ethnicity Data in Clinical Trials—Guidance for Industry and Food and Drug Administration Staff
- Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry
She emphasizes that African Americans are willing--sometimes more willing than others--to participate in clinical trials. But they must be invited, and trials must be designed with consideration of the obstacles they face because of where they live and how they work.
Dr. Bull serves as a consultant focused on drug development and regulatory considerations; she helps guide the strategic development and implementation of clinical trial protocols. She has served in various roles, including as assistant commissioner at FDA with a focus on diverse populations and clinical trials.

Chasing My Cure: an Interview with Dr. Fajgenbaum
WCG Talks Trials
11/18/19 • 37 min
In this episode, WCG’s President of Patient Advocacy, Steve Smith, sits down for an interview with Dr. David Fajgenbaum, Assistant Professor of Medicine at the University of Pennsylvania and Author of Chasing My Cure: A Doctor’s Race to Turn Hope Into Action. In this podcast, you’ll hear Steve and Dr. Fajgenbaum discuss what it’s like to be a patient of a rare disease – in this case Castleman’s disease – and Dr. Fajgenbaum’s fight to find a cure for his own disease. This is a story of incredible courage and uniquely acquired wisdom. It is a story of triumph over adversity. And it’s a story of life changing, groundbreaking hope.

09/16/24 • 28 min
Join Desiree Underwood-Williams, director of project management organization at WCG and guest Steve Smith, CEO of SteveSmithPlans LLC and facilitator of the WCG Patient Forum, as they recap the latest Patient Forum Focus Session on breakthrough science and community engagement. Discussion highlights include:
- The impact of medical diagnoses on families with Sickle cell disease and melanoma.
- New research in cell and gene therapy that’s directly impacting Sickle cell disease and melanoma patients.
- New diversity laws shaping the future of drug development.
- Community engagement and how patients can get involved in their care.
- And more insights into the WCG Patient Forum, now in its fifth year.
Tune in to learn more about clinical research, community engagement, and the latest developments in patient care.
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FAQ
How many episodes does WCG Talks Trials have?
WCG Talks Trials currently has 80 episodes available.
What topics does WCG Talks Trials cover?
The podcast is about Life Sciences, Health & Fitness, Medicine, Podcasts, Science and Pharmaceutical.
What is the most popular episode on WCG Talks Trials?
The episode title 'Connecting Patients to Trials: Bernadette Siddiqi of The Michael J. Fox Foundation for Parkinson’s Research' is the most popular.
What is the average episode length on WCG Talks Trials?
The average episode length on WCG Talks Trials is 24 minutes.
How often are episodes of WCG Talks Trials released?
Episodes of WCG Talks Trials are typically released every 8 days, 23 hours.
When was the first episode of WCG Talks Trials?
The first episode of WCG Talks Trials was released on Mar 6, 2019.
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