On August 23, 2022, the below update was posted on ClinicalTrials.gov What’s New section, regarding the updates made to the ClinicalTrials.gov Beta website and clarification on the FAQ related to the requirement on submitting results for a Non-applicable Clinical Trial.
ClinicalTrials.gov Beta Website:
- In addition to improved search for clinical studies and a tabular view of search results, new features, improvements and bug fixes are added to the ClinicalTrials.gov Beta website.
Moreover, the feature for ‘Table view of the study record’ will be coming soon. Detailed information on the updates can be found at Release Notes | Beta ClinicalTrials.gov.
- Under FDAAA 801, results submission is not required for a non Applicable Clinical Trial (for example, a phase 1 trial studying an FDA-regulated investigational new drug). If a responsible party chooses to submit results for such a trial voluntarily, the Voluntary Submissions (PDF) provision of FDAAA 801 may apply.
Additionally, under the Voluntary Submissions (PDF) provision, a responsible party who submits results for such non-applicable clinical trial must submit complete clinical trial results information and must also submit results for each Applicable Clinical Trial that is required to be submitted to FDA for the same use studied.
More information on the FAQ can be found here.