Credit: Esther Dyson
The US Department of Health and Human Services (HHS) has proposed a rule that would require more public disclosure of clinical trial results.
The Notice of Proposed Rulemaking (NPRM) adds to current requirements for submitting trial information to ClinicalTrials.gov.
Most notably, the rule would require the submission of summary results from studies of products not yet approved by the US Food and Drug Administration
(FDA).
The National Institutes of Health (NIH) have created a draft policy that would extend similar reporting requirements to all clinical trials funded by NIH.
About the NPRM: Who, what, and when
The NPRM details new procedures for meeting the requirements established by the Food and Drug Administration Amendments Act of 2007 (FDAAA) to improve public access to clinical trial information.
The proposed rule specifies how information about a clinical trial would need to be submitted to ClinicalTrials.gov. It would not affect requirements for the design or conduct of clinical trials or for the data that must be collected during these trials.
The rule would apply to controlled, interventional studies of drugs, biological products, and devices that are regulated by the FDA. This excludes phase 1 studies of drugs and biological products and feasibility studies of devices.
In general, clinical trials of products regulated by the FDA will meet one or more of the following criteria: include one or more sites in the US; study a product manufactured in the US or its territories and exported for use in a trial outside the US; or be conducted under an FDA investigational new drug application or investigational device exemption.
The NPRM would require the parties responsible for applicable clinical trials—such as the sponsor or a designated principal investigator—to register the trial at ClinicalTrials.gov no later than 21 days after enrolling the first participant.
Registration consists of submitting 4 categories of data elements that are specified in the NPRM: 1) descriptive information, 2) recruitment information, 3) location and contact information, and 4) administrative information.
The parties responsible for the trial would also be required to submit a summary of the study’s results to ClinicalTrials.gov, generally no later than 12 months after trial completion.
However, the NPRM includes procedures for delaying results submission and for requesting extensions to the results submission deadline for good cause.
NIH policy: Extending the NPRM
The proposed NIH policy would make requirements in the NPRM applicable to all NIH-funded awardees and investigators conducting clinical trials, regardless of study phase, type of intervention, or whether they are subject to the rules proposed in the NPRM.
NIH awardees would be expected to ensure submission to ClinicalTrials.gov of the same type of registration and results information, and in the same timeframes, as responsible parties whose trials are subject to the FDAAA and the regulations proposed in the NPRM.
For clinical trials subject to only the proposed NIH policy (not the FDAAA), the NIH would post submitted information, in general, no later than 30 days after it is submitted.
An NIH-funded clinical trial that is also subject to FDAAA would need to have only one entry in ClinicalTrials.gov containing its registration and results information.
Open for comment
The public may comment on any aspect of the NPRM or the proposed NIH policy.
Written comments on the NPRM should be submitted to docket number NIH-2011-0003 at www.regulations.gov. Commenters should indicate the specific section of the NPRM to which each comment refers.
Written comments on the proposed NIH policy should be submitted to the Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, via email at clinicaltrials.disseminationpolicy@mail.nih.gov, mail at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, or fax at 301-496-9839.
