All Content Clinical Leader

  1. Patient Trust In Pharma Is Low; Here's How To Rebuild It 2/2/2026

    CISCRP's Annick de Bruin and Shalome Sine provide strategies for building patient trust based on the findings from their Perceptions & Insights Study.

  2. Why Dr. Robert Califf Isn't Pulling His Punches Anymore 1/30/2026

    In this exclusive video interview, former FDA commissioner Robert Califf, MD reflects on quality, risk aversion, misinformation, and why clinical trials need sharper focus — not more data. 

  3. The U.S. Trial Advantage Is Eroding 1/30/2026

    Once the go-to location for trials, the U.S. is now seeing competition from APAC, driven by political, economic, and workforce pressures domestically and rapid growth abroad.

  4. CRL Transparency Comes With Real Trade-Secret Risks 1/29/2026

    Sure, increased transparency around Complete Response Letters sounds good, but Elizabeth Jungman warns that FDA’s new disclosure approach may expose sponsors’ confidential and commercially sensitive information.

  5. Can The FDA Easily Replace The Experience It Has Lost? 1/29/2026

    Elizabeth Jungman describes how early retirement programs and workforce reductions led to the loss of highly experienced FDA leaders, creating gaps in institutional knowledge that affect complex regulatory decisions.

  6. We Can't Really Interpret R3 In A Vacuum 1/29/2026

    Having problems interpreting ICH guidelines or deciding what to do next? Sophia McLeod offers some advice and resources, and then she also explains why she thinks it’s good that we’re living in this “show-your-work” kind of era.

  7. Engage Early With The FDA On AI … Or Expect Problems 1/29/2026

    You've heard it before; sponsors must engage FDA early when using AI in clinical development. Hilary Marston warns that late engagement can cause irreparable damage to your regulatory strategy.

  8. FDA Talent Loss Is Real — And It's Not Evenly Distributed 1/29/2026

    Hilary Marston discusses how staffing losses at FDA are uneven across divisions, with particularly heavy impact in innovative areas like AI and real-world evidence.

  9. Policy by Press Release Is Now a Real Problem 1/29/2026

    Sophia McLeod, advocacy advisor, at ACRO, explains what ACRO members are concerned about regarding the FDA staffing losses. She also talks about the effects of "policy by press release" rather than traditional notice-and-comment periods.

  10. Making AI Safety Routine: How Sites And Sponsors Can Continuously Monitor Clinical AI 1/29/2026

    Learn why the next frontier in AI governance will involve real-time surveillance of algorithmic performance across institutions with guidance from Akshaya Bhagavathula and Michelle A. Williams.