A Special Protocol Assessment (SPA) , is an advanced declaration from the Food and Drug Administration affecting the pharmaceutical industry and medical research. It pertains to an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses that are acceptable for FDA approval. The purpose of a SPA is to allow a company to run or initiate a clinical trial of an experimental drug without fear that the FDA will object to the trial design itself, in the event that the company subsequently applies for product approval.
