70 episodes

Insights from leaders in clinical research and trial optimization, hosted by the WCG Clinical.

WCG Talks Trials WCG

    • Science

Insights from leaders in clinical research and trial optimization, hosted by the WCG Clinical.

    Ethical Review and AI in Clinical Trials

    Ethical Review and AI in Clinical Trials

    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 rese...

    • 39 min
    Addressing Measurement Challenges for PTSD Trials with Technology

    Addressing Measurement Challenges for PTSD Trials with Technology

    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.

    • 21 min
    Creating Partnerships: Aligning Vendor Support for Success in Clinical Research

    Creating Partnerships: Aligning Vendor Support for Success in Clinical Research

    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.

    • 20 min
    WCG's IRB Policy Change: Harmonizing Consent (Part 2)

    WCG's IRB Policy Change: Harmonizing Consent (Part 2)

    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.

    • 8 min
    WCG's IRB Policy Change: Harmonizing Consent (Part 1)

    WCG's IRB Policy Change: Harmonizing Consent (Part 1)

    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.

    • 6 min
    The Ethical and Safety Considerations of Accelerating Oncology Trials

    The Ethical and Safety Considerations of Accelerating Oncology Trials

    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 biosafe...

    • 43 min

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