The Quintessential Guide To Planning A Successful Clinical Trial

By Michelle Bousquet, Ph.D.

The route from bench to bedside is not for the faint of heart. It’s a long, expensive, and complicated process that rarely results in drug approval. Finding a promising drug candidate and getting into the clinical phases of research is hard enough; getting it through trials is even harder. Our discovery that >30% of clinical trials are also failing to meet timelines for major study milestones – such as last subject in – seems to add insult to injury. And the single biggest reason for the high failure rate in these intricate, often multi-national trials is simply a failure to plan.

A proper planning process is crucial to the operational success of a study. Not only should it focus on ideal scenarios, but it should also incorporate risk-mitigation strategies and well-defined contingency plans that can correct issues before a trial completely derails. To expand upon our recent white paper, ‘Rescue’ is Not a Dirty Word, we want to tackle the complex study planning process. In this white paper, we will cover the multiple strategies, tactics, and considerations that should be given attention at the beginning of every clinical study.