The team at Health Decisions enjoys nothing more than helping a sponsor bring a successful product to market months or years ahead of schedule. Through a combination of adaptive design and adaptive operations, we have succeeded in accelerating market entry for many products, sometimes by more than two years, as in the case of one HPV diagnostic.
But there are some things that neither adaptive design nor adaptive operations can overcome. These include data showing unacceptable efficacy or safety for a test drug/biologic or sensitivity and specificity for a diagnostic. In one recent study of a new pain therapy, interim efficacy data for a test product was quite disappointing – there was simply no signal. We recommended and the sponsor accepted early termination of the trial for futility. Early stopping saved > $4M for the sponsor and allowed immediate reallocation of resources within the sponsor’s portfolio.
Early termination for futility is not exactly cause for celebration for a sponsor or CRO. In this case, the sponsor got disappointing news about a once-promising product and we reduced projections of revenues from the study. On the other hand, the sponsor appreciates the precise and rapid interim review and intervention to prevent futile spending. An additional obvious benefit is preventing administration of an ineffective experimental treatment to more patients.
Our goal is to ensure that no study fails for any reason other than the failure of the test product itself. Our methodology, Agile Clinical Development, allows us to meet this goal. If the product fails, we fail it fast. If the product succeeds, we get it to market fast. We can celebrate the success of the methodology even as we mourn a failed product.