Five Preventable Clinical Design Pitfalls and How to Avoid Them

Published: 22 July 2026

How to design clinical trials that reduce regulatory friction, strengthen evidence, and accelerate approval readiness

Author(s): Ian Fisher, Keith McDonald, & Parvin Fardipour

Clinical trial success is rarely determined by science alone. Too often, promising therapies fail due to preventable design flaws such as misaligned endpoints, unrealistic operational assumptions, limited regulatory alignment, or evidence that does not translate to real‑world patient populations. The consequences can be significant, including protocol amendments, delays, inconclusive results, and missed approval opportunities.

This white paper examines five of the most common and avoidable clinical design pitfalls and outlines how sponsors can take a more proactive, decision‑focused approach to development that reduces risk, strengthens evidence, and improves the likelihood of success.