Registration Trial
A clinical trial specifically designed to support a regulatory submission for drug approval. The term is essentially synonymous with pivotal trial and indicates that the study's design, endpoints, and statistical plan have been agreed upon with regulatory authorities in advance.
Technical Context
Registration trials are designed specifically to support regulatory submission. This means: the primary endpoint must be accepted by the target regulatory agency, the control group must be appropriate (agency preferences may differ — FDA may prefer placebo-controlled while EMA may prefer active comparator), the patient population must reflect the intended indication, the trial duration must be sufficient, and the statistical analysis plan must meet regulatory standards. The Special Protocol Assessment (SPA) process with the FDA provides written agreement on the design before the trial begins, ensuring that if the trial succeeds as designed, the results will support approval. Registration trials for peptide drugs typically cost $50-300M and take 2-4 years to complete.