Julia Jenkins, EveryLife Foundation for Rare Diseases: Patient’s shape science-driven public policy

In the most recent episode of WCG Talks Trials, we are joined by three industry experts, Amy Thue and Shelby Ward from WCG, and Russell Lampman from Merck to discuss the topic of optimizing vendor support, and ultimately the success, of clinical trials.

Listen in as we dive into feedback and perspectives from both the sponsor and vendor side of the table—for valuable take-aways and insights into how vendor support is best aligned across all stakeholders.

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. 

In Part 1 of this discussion, Currien MacDonald, MD, CIP Medical Chair Director for WCG's IRB, discusses a policy change that is going into effect for WCG IRB with Lindsay Abrahams, Regulatory Chair Director. 

Lindsay and Currien discuss the concise summary and its application to consent forms, especially for WCG.

In this episode of WCG Talks Trials, our expert panel discusses various ethical, safety, and logistical challenges in accelerating clinical trials for gene and cell therapies in oncology. The conversation explores the role of Institutional Review Boards (IRBs), Institutional Biosafety Committees (IBCs), Endpoint Adjudication Committees (EACs), and Data Monitoring Committees (DMCs) in overseeing these trials, addressing issues such as patient safety, complex trial designs, and emerging biosafety concerns. Our panelists emphasize the importance of transparent communication and collaboration between IRBs and IBCs, highlighting the need to balance the urgency of advancing research with ethical considerations. Additionally, the podcast explores unrealized ethical and safety issues, such as the pace of technological advancements and potential risks associated with gene editing. The speakers also touch upon future opportunities in oncology research, including precision medicine, artificial intelligence, wearable devices, and accelerated regulatory pathways.

In episode 10 of WCG Talks Trials, we are joined by Catherine Gregor, the Chief Clinical Trial Officer at Florence Healthcare, to discuss Florence’s recent Research Revolution event and the importance of site enablement in clinical research. Listen in as we recap Research Revolution, share insights on emerging clinical trial trends and innovations, and have a candid conversation about what stands in the way of successful site enablement in clinical research. 

In this episode of WCG Talks Trials, we are joined by Elizabeth Weeks-Rowe, CCRA, author of The CRA’s Guide to Monitoring Clinical Research, 6th Edition.

Led by WCG Director of Publications and Content, Leslie Ramsey, the discussion will delve into the ways the clinical trials industry has become more complex and technologically focused and the challenges clinical research associates (CRAs) face as monitors of clinical trials.

Host: Leslie Ramsey, Director of Publications and Content, WCG

 Participant: Elizabeth Weeks-Rowe, Independent Clinical Research Consultant

In this episode of WCG Talks Trials, we are joined by MAGI@home Steering Committee members, Jennifer Peterson, Director, Head of Clinical Quality at M3 Wake Research, and Geoffrey Schick, Director, Strategic Site Partnerships at WCG. 

Led by Carmin Gade, Chief Marketing Officer at WCG, the discussion will delve into the insights and value MAGI events provide that enable attendees to achieve success in their roles and professional development.

This episode of WCG Talks Trials, hosted by Kelly Fitzgerald, Executive IRB Chair and Vice President of IBC Affairs at WCG, dives into the topic of diversity and inclusion with technology in decentralized clinical trials (DCTs). The episode explores the transformative opportunities that DCTs present for addressing diversity gaps in clinical research. The discussion features a panel of experts, including Otis Johnson, former Chief Diversity, Inclusion, and Sustainability Officer at Clario; Archana Sah, a seasoned clinical development leader with a focus on oncology and healthcare technology; and Ken McCann, a physician with a background in pediatrics and a keen interest in social determinants of health. The panelists share insights on how DCTs can improve accessibility, overcome barriers, and enhance representation in clinical trials, emphasizing the potential for these trials to be a game-changer in making clinical research more equitable and inclusive. 

Guests:

• Archana Sah MS (Pharm.) PMP 
• Otis Johnson, PhD, MPA
• Ken McCann, MD 

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 

Listen to the latest episode of WCG Talks Trials to hear from experts on the importance of diversity, equity, and inclusion in clinical research and how intersectionality plays a role in promoting DE&I. We'll discuss why diversity is pivotal for comprehending the full spectrum of clinical care mechanisms and review effective DE&I strategies being deployed today. Discover how communities can be more actively engaged in clinical research and hear real-world examples of success stories in promoting diversity, equity, and inclusion within clinical research.

Moderator:

• Scott J. Hunter, PhD - Senior Scientific Expert, Neurodevelopmental and Rare Pediatric Diseases, WCG

Speakers:

• Sonya Dinizulu, PhD - Associate Professor of Psychiatry and Behavioral Neuroscience, University of Chicago 
• Desiree Underwood-Williams, PMP, CLSSBB – Director, Project Management Office, WCG