Best Practices for Special Protocol Assessment

Abstract

The Special Protocol Assessment (SPA) process is a valuable mechanism for the Food and Drug Administration (FDA) to provide early feedback to sponsors on key development programs. Comprehensive review of pivotal studies designed to support regulatory approval has the potential to identify key study design issues early in the drug development process, facilitate sponsor-FDA discussion of key issues, and ensure that FDA and the sponsor are aligned and clear as to what the study needs to deliver in order to support approval. Although the SPA process predates the Critical Path Initiative, it is consistent with FDA’s goal of increasing transparency and facilitating efficient and effective drug development.

FDA and industry expend significant resources in support of the SPA process. In order for the intended goals to be achieved, it is important that the process be applied consistently, be accomplished in a timely manner, and allow for agreements to be documented in an efficient manner.