It’s every drug company’s worst nightmare: spending millions of dollars on a Phase 2 clinical trial only to discover that the data that has been gathered just isn’t up to the task of supporting a decision regarding whether to move forward or not with a given product. If it sounds far-fetched to suggest that such a significant investment could fail to yield usable results, consider an analysis of Clinicaltrials.gov published by the Journal of the American Medical Association in May, 2012 that showed more than half of all clinical trials fall under this discouraging banner.
The correlation that huge sums of cash do not equal usable data should come as no surprise to individual investigators who are familiar with the lack of results that stem from underpowered and poorly-planned clinical efforts. This particular truth is only just now starting to gain awareness amongst pharma decision-makers, however, and as a result a major push is underway to evaluate and implement alternative trial designs in an attempt to enhance data value.
Adaptive design trials are increasingly recognized as a powerful method for ensuring that product development investment provides useful data. Adaptive trials permit researchers to more efficiently identify the effective dose and the relevant study population for a novel drug candidate. Both these factors improve the chance that high-value data is collected and that the correct dose is selected for the Phase 3 trial.
Far too often a traditional clinical trial design is doomed mid-way through execution as researchers realize that assumptions made at the onset of the study design are no longer valid or capable of delivering a result that will provide decision-makers with meaningful data to plan the future of a particular drug candidate. Adaptive trials circumvent this unfortunate state of affairs by offering clinicians a flexible toolset that can react to new information while preserving the integrity and validity of the trial, delivering high-value data that can be used to direct future development decisions.
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Benjamin Hunting
Aptiv Solutions Blogging Team
