In this episode of WCG Talks Trials, we are joined by host Joanne Thomas, clinical reviewer and patient advocate at WCG, along with our guest Currien MacDonald, medical chair director at WCG. This episode covers the roles of IRB in ethical clinical research, frequently asked questions, and a general overview of the IRB’s role in clinical trials.

This episode of WCG Talks Trials addresses site feasibility challenges impacting the clinical trials industry. Join Michelle Yu, associate director of clinical strategy at WCG, and our guest Trevor Cole, director of client delivery, site and strategic operations for WCG, as we discuss approaches to adopt innovative feasibility and site start-up solutions.

Here are links to documents referenced in this episode:


Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement

• Main Article: https://ascopubs.org/doi/10.1200/OP.20.00821  
• PDF Data Supplement: https://society.asco.org/sites/new-www.asco.org/files/content-files/about-asco/documents/2020-ASCO-Site-Feasibility-Assessment-Statement-Data-Supplement-for-JCO-OP.pdf 

Join our Chief Analytics Officer Silvio Galea, along with Dr. Donna Snyder & Dr. Barbara Bierer to discuss opportunities on the ethical and regulatory challenges regarding artificial intelligence in clinical trials. The discussion is focused through the lens of the IRB review, and how a multi-stakeholder task force led by the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women's Hospital and WCG will address the growing need for guidance in this rapidly evolving area of research.

In this episode of WCG Talks Trials, we are joined by WCG clinical science experts as they discuss traditional measurement challenges for PTSD trials and how the use of an electronic CAPS-5 scale is improving administration and scoring errors. 

Tune in as we discuss the CAPS-5 scale, the opportunities and benefits of using an electronic version to help standardize scale administration and scoring across clinical research, and the promising results to date. 

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.