Protocol Design Featured Articles

31. 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.

32. 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.

33. 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.

34. 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.

35. New FDA Program Adds Flexibility For Ultra-Rare Disease Submissions 9/23/2025

    Life science legal experts Mark A. Tobolowsky and Frank J. Sasinowski discuss the FDA's new Rare Disease Evidence Principles (RDEP) initiative.

36. 3 Ways Biotechs Can Relieve The Burden Of Their First Clinical Trial 9/23/2025

    Discover how non-profit partnerships, adaptive trial design, and real-world evidence can all play a part in helping biotech's successfully launch their first-in-human trial.

37. 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.

38. 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.

39. 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.

40. 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.