Protocol Design Featured Articles

  1. How The FDA, MHRA, & EMA Differ On Externally Controlled Trials 10/23/2025

    As the FDA, MHRA, and EMA release draft frameworks on externally controlled trials, sponsors face differing expectations. The U.K. leans pragmatic, the U.S. remains cautious, and Europe’s guidance is still evolving — leaving global trial planners to navigate regulatory gray zones.

  2. Careful Outsourcing Proves Key To Targeted Protein Degradation Drug Development 10/21/2025

    Discover how partnerships — especially with capable CROs — as well as resilient supply chains, digital enablement, regulatory foresight, and specialized talent impact the success of targeted protein degradation therapies.

  3. Whole-Body MRI Biomarkers Unlock A Fuller Picture In Neuromuscular Trials 10/15/2025

    Discover the utility and promise of whole-body MRIs a digital biomarkers in neuromuscular clinical trials.

  4. Trends In Rare Disease Trials: Evaluating Trial Types' Pros, Cons, And Adoption Rates 10/14/2025

    In the second article of the series, Beroe Inc. Lead Analyst Sapna Rani provides a comprehensive evaluation of leading trial types for rare disease development and compares adoption rates, design-specific trade-offs, and practical selection criteria.

  5. Trends In Rare Disease Trials: Trial Designs, Challenges, And Regulatory Progress 10/13/2025

    Beroe Inc. Lead Analyst Sapna Rani unpacks the evolution of trial design types in rare disease research, analyzes ongoing challenges, and examines how regulatory support is enabling innovation in part one of this three-part series.

  6. Oncology PI Shares Lessons Learned And Successes Working With Basic Scientists 10/9/2025

    Ranee Mehra, MD, shares her successes and discusses how they shape her approach to future research, as well as details the importance of working closely with basic scientists.

  7. How One Biopharma Company Overcame Trial Failure 10/6/2025

    PolyPid's Eyal Shoshani highlights the company's second attempt at its SHIELD trial, including things they did to revamp the trial design and the impact of AI in this and future trials.

  8. Proximity To Patients Helps Unicycive Reduce Pill Burden 10/1/2025

    Unicycive CEO Shalabh Gupta, MD, shares how the company integrates patient feedback into the design of its trials, thus reducing pill burden.

  9. RWE Is Growing Up, And Here's Why That Matters 9/29/2025

    Real-world evidence is shifting from the margins to the mainstream of drug development, but data quality, trust, and regulatory clarity remain hurdles. ISPOR is helping set the standards to guide its future.

  10. Seriously … Are We Making Any Progress? 9/25/2025

    Ken Getz’s DPHARM talk revealed how ballooning data collection in trial protocols drives costs, delays, and site burden. New ICH E6 R3 guidance pushes for simpler, more flexible designs, but real progress will require collaboration — and restraint.