When does the FDA require the primary results of a trial to be posted in the clinical trial database?

The requirement set by the FDA for posting primary results of a clinical trial is primarily centered around the timeline of the study completion, specifically regarding approved products. The FDA mandates that results must be posted within 12 months after the last patient's visit for trials related to products that have received market approval. This policy is designed to promote transparency and improve public access to important clinical trial data, thereby enhancing the integrity of the regulatory process and ensuring that the medical community and the public can benefit from the findings of clinical research promptly.

In contrast, other timelines presented do not accurately reflect the FDA’s requirements. For instance, the six-month and 24-month timelines do not align with the criteria for posting primary results related to approved products. Furthermore, the stipulation regarding posting within 12 months after the start of a trial for any clinical trial is not correct, as it specifically pertains to the completion of the trial and the outcomes observed rather than the initiation.