Clinical Guest Contributors

1. 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.

2. 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.

3. 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.

4. Redesigning Oncology Trials Around Tumor Vulnerability: The Rise of WEE1 And DDR Strategies 9/8/2025

   As clinical progress with DNA damage response (DDR) continues to evolve, research must respond with adaptive models, smarter combinations, and biomarker-informed patient selection.

5. Rethinking Clinical Development In The Age Of Synthetic Cell Therapy 9/5/2025

   Synthetic biology, especially when applied to engineered stem cells, such as induced mesenchymal stem cells (iMSCs), represents a new frontier. But to get these cells to patients, we need to reimagine how we develop and evaluate them.

6. How Digital Twins Are Rewriting Clinical Trials 9/2/2025

   While the benefits of digital twins to accelerate clinical trials are undeniable, many questions about their use are still unanswered and go far beyond technology.

7. 3 Quick Takes From A PI With 100+ Trials To His Name 8/29/2025

   Principal investigator Norman B. Gaylis, MD, shares his perspective on patient recruitment, protocol design, and vendor selection.

8. Alzheimer's Trial Targeting Amyloid Beta Oligomers Sees Cost Savings, Patient Satisfaction With New Screening 8/29/2025

   Acumen Pharmaceuticals' Eric Siemers, MD, discusses their novel Alzheimer's disease screening method and trial design for investigational drug sabirnetug that keeps both the clinical site and patient experience in mind. 

9. Insuring Global Clinical Trials: Navigating Risks Across Borders 8/28/2025

   Foreign clinical trials insurance is indispensable. Learn its features, its benefits, and why it's needed.

10. Misconceptions About Cancer Clinical Trials And How To Overcome Them 8/27/2025

    Medical oncologist Wasif Saif, MD, MBBS, discusses many of the misconceptions held by patients and clinicians about cancer clinical trials.