Five Preventable Clinical Design Pitfalls And How To Avoid Them

By Ian Fisher, Head of Development Analytics, Regulatory Affairs and Drug Development Solutions, Keith McDonald, FRCPharm, FFPM(Hon.) Regulatory Strategy Advisor, and Parvin Fardipour, PhD, Decision Sciences

The success of a clinical program is largely influenced by clinical trial design, coherence, and execution. Though late-stage failures are often blamed on inadequate demonstration of safety and efficacy, they are more often a failure of early planning, i.e., regulatory engagement and alignment between clinical objectives and commercial goals. These oversights can result in operational risks, excessive protocol amendments, overrun budgets, timeline setbacks, non-compliance, and overall program rework or failure.

But despite the obstacles, there are a number of solutions available to increase the likelihood of trial success, including designing a robust clinical development plan with clear scientific rationale, identifying a patient population that enables signal detection, assessing patient burden and willingness to participate, and ensuring ongoing alignment with regulatory expectations. To learn more about these pitfalls and their solutions, download the complete white paper.