To SPA Or Not To SPA: Understanding Special Protocol Assessments

The Guidance for Industry: Special Protocol Assessment (SPA) was issued in May of 2002 with the express purpose of allowing FDA to provide input into the design of phase 3 clinical protocols, animal carcinogenicity, and product stability, thereby giving FDA the opportunity to come to agreement with the product sponsor on the scientific and regulatory requirements of the study prior to its initiation. This paper will limit itself to the consideration of phase 3 clinical protocols and will not deal specifically with the process of requesting and executing an SPA. Rather, we will provide strategic recommendations for the effective use of SPAs in product development and explain how this SPA FDA guidance is best used in light of the recommendation in the Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants (May 2017) for each product sponsor to conduct an end-of-phase-2 (EOP2) meeting. Both guidances were developed to encourage product sponsors to interact with the FDA prior to initiating their phase 3 program, but the timing and the strategy for each company may differ depending on the specifics of their development program, resulting in a product sponsor’s choosing to participate in both FDA guidance processes or only one.