The Phoenix Strategy: The Strategic Mandate of MSLs in the Aftermath of Clinical Trial Attrition

Author(s): Gaurav R. Pandey, PhD, MS (Pharm)

Introduction

In the critical landscape of pharmaceutical development, the transition from phase II (safety) to phase III (efficacy) is often described as the “valley of death”, with approximately 70% of drug development projects failing to progress further. Even for those who reach Phase III, the hurdle remains high, with 57% of failures attributed to inadequate efficacy and 17% to safety concerns. Clinical trial attrition has a paradigm influence over the risk of not only impacting the lives of patients but also the business strategy and market & investor sentiments for the company. The toll can be from risking few lives to billion dollars at the stake. Thus, the clinical attrition or negative trial results needs to be communicated with lots of responsibilities as well as strategic and effective way. What’s more important is learning and understanding the factors responsible for trial halt equipping the company for all future decisions.