On November 19, 2014, the U.S. Department of Health and Human Services issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to implement reporting requirements for clinical trials that are subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). According to FDA Commissioner Margaret A. Hamburg, MD:
This proposed rule would close an important gap, making additional information about clinical studies of investigational drugs, medical devices, and biological products available to the public. It would help eliminate unnecessary duplicative trials, advance biomedical innovation, and provide the public with a much richer understanding about the clinical trials for these products.
Further details are in a summary of proposed changes. Notable changes from current requirements and practice include:
- A streamlined approach for determining which trials are subject to the proposed regulations and who is responsible for submitting required information.
- Expansion of the set of trials subject to summary results reporting to include trials of unapproved products.
- Additional data elements that must be provided at the time of registration (not later than 21 days after enrolling the first participant) and results submission (generally not later than 12 months after completion).
- Clarified procedures for delaying results submission when studying an unapproved, unlicensed, or uncleared product or a new use of a previously approved, licensed, or cleared product and for requesting extensions to the results submission deadline for good cause.
- More rapid updating of several data elements to help ensure that users of ClinicalTrials.gov have access to accurate, up-to-date information about important aspects of a clinical trial.
- Procedures for timely corrections to any errors discovered by the responsible party or by the Agency as it processes submissions prior to posting.