Could Your Phase II Or Phase III Clinical Trial Benefit From A Special Protocol Assessment (SPA)?

Special Protocol Assessments (SPA) are an opportunity to get upfront input and buy-in from FDA on the scientific, regulatory, and statistical rigor of your planned adequate and well controlled clinical trial. SPAs can be done for clinical protocols, non-clinical carcinogenicity protocols, and CMC stability protocols.

In the case of clinical protocols, an SPA is highly advisable for any phase III clinical trial and for phase II clinical trials for programs seeking accelerated approval. The SPA will give you an opportunity to finalize not only the protocol but case report forms and the statistical analysis plan as well.