As part of a project that examined the degree to which sponsors of clinical research are complying with federal requirements for the reporting of clinical trial results, the Clinical Trials Transformation Initiative (CTTI) and the authors of the study are making the primary dataset used in the analysis available to the public. The full analysis dataset, study variables, and data definitions are available as Excel worksheets from the CTTI website and on the Living Textbook’s Tools for Research page.
The Department of Health and Human Services is extending the public comment period for the Notice of Proposed Rulemaking (NPRM) on Clinical Trials Registration and Results Submission. The comment period for the proposed rule 79 FR 69566, published on November 21, 2014, will close at 5 p.m. Eastern Standard Time (EST) on March 23, 2015.
Developed by NIH in close coordination with the FDA, the proposed rule details procedures for meeting the requirements established by the Food and Drug Administration Amendments Act (FDAAA) to improve public access to clinical trial information. FDAAA and the proposed rule apply to certain interventional studies of drugs, biological products, and devices that are regulated by the FDA but, generally, not to phase 1 trials of drugs and biological products and small feasibility studies of devices. The proposed rule specifies how data collected and analyzed in a clinical trial would be required 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 clinical trials.
Of particular importance in the NPRM is FDAAA Section 801 (expanded clinical trial registry and results data bank), which includes information about the responsible party, applicable clinical trials, deadlines for submitting required information, and penalties.
Individuals and organizations interested in submitting comments on the NPRM, identified by RIN 0925-AA52 and Docket Number NIH-2011-0003, may do so by mail or electronically. Details and addresses for submitting comments are here.
Summary of Proposed Changes - NPRM/NIH Policy
JAMA Viewpoint: Sharing and Reporting the Results of Clinical Trials