When are primary results of the trial required to be posted in the ClinicalTrials.gov database?

The requirement to post primary results in the ClinicalTrials.gov database is critical for promoting transparency in clinical research. Posting these results ensures that data from clinical trials are accessible to the public, which can lead to improved research practices and protect public health.

The correct answer specifies that primary results must be posted within 12 months after the last patient's visit for an approved product. This timeframe supports the need for timely dissemination of trial data while allowing enough time for researchers to analyze the results comprehensively before making them public.

In contrast, other options suggest different timelines that either do not align with regulatory requirements or do not account for the finalization of data analysis. For instance, results being posted after the final analysis is conducted could potentially lead to delays beyond the required 12 months if not strictly adhered to. Similarly, posting results before drug approval doesn't consider that results from trials of non-approval products also have a required timeline, and stating "within 6 months after trial completion" is not aligned with the 12-month requirement for approved products. Thus, the selected option accurately reflects established guidelines and emphasizes the importance of timely reporting of clinical trial results.