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.

If you do decide to request an SPA, here are a few helpful tips:

• Submit your SPA request at least 90 days prior to intended study initiation.  This provides 45 days for FDA review and an additional 45 days for external consultant review if it is deemed necessary.
• For phase III clinical trials, coordinate your SPA with your End of Phase 2 meeting.
• Make sure you communicate your plan with your Regulatory Project Manager (RPM) at FDA.

For more information on SPA meetings, check out this FDA guidance.

Have you been through a recent SPA meeting?  If so, we would love to hear about your experience.