Clinical Guest Contributors

  1. Combining RWD And Machine Learning To Determine Meaningful Patient Populations 9/22/2025

    Combining RWD with advanced ML models offers a powerful and transformative solution to optimize patient recruitment.

  2. Bridging Community And Central Hospitals With Japan's DCT Model 9/19/2025

    Regulatory support and improved DCT infrastructure, as well as a uniquely Japanese approach to site relationships, are advancing the DCT landscape in Japan, explains consultant Takuma Matsunaga.

  3. RWD Helps Abbvie Bridge Oncology Trial Data Gaps 9/18/2025

    AbbVie Vice President of Global and U.S. Medical Affairs Oncology Svetlana Kobina, MD, Ph.D., discusses how integrating real-world data (RWD) with RCTs can fill critical data gaps.

  4. FDA Issues New Guidance For Clinical Trial Dosage Of Oncology Therapeutic Radiopharmaceuticals 9/17/2025

    The FDA has issued a draft guidance titled Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development and is accepting public comments through October 20, 2025.

  5. CISCRP's Mobile Health Exhibit Brings Clinical Trial Education To Communities 9/17/2025

    CISCRP shares its mobile education project brings clinical trial awareness and information directly to communities.

  6. RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It? 9/16/2025

    The timing is now for pharma to be all-in on using wearables as their new business strategy, says Digital Medicine Society (DiMe) Director of Partnerships Smit Patel, PharmD.

  7. How Brazil's New Law Is Redefining The Country's Clinical Research 9/15/2025

    Brazil aims to revamp its clinical research industry with the introduction of a new law intended to make trials faster, empower local ethics committees, and give patients greater post-trial access to investigational drugs.

  8. 4 Steps To Make A Business Case For Digital Endpoints 9/12/2025

    Anita Burrell explains how to build a business case for including digital endpoints and the elements to consider.

  9. Are Pragmatic Trials The Patient Recruitment Solution We've Been Looking For? 9/9/2025

    TransCelerate's Rob DiCicco reintroduces the "pragmatic trial" design concept, discusses its potential benefits, and provides resources for its integration.

  10. The New FDA Era Of Radical Transparency And Pervasive Oversight 9/9/2025

    The first half of 2025 has been transformative for biopharmaceutical quality and regulatory affairs, with the FDA leading the charge with four significant changes. Curadian Group's David Grote discusses implications for all four.