Category Archives: Policy

Enhancing the Transparency of Clinical Trial Results

Clinical trials, Policy, Regulatory issues, , ,

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.

NIH Finalizes Policy on Genomic Data Sharing

Data sharing, Informed Consent, Policy, , , , , , ,

The National Institutes of Health has issued a final NIH Genomic Data Sharing (GDS) policy to promote data sharing as a way to speed the translation of data into knowledge, products, and procedures that improve health while protecting the privacy of research participants. The NIH news release contains highlights of the policy.

The GDS policy is an extension of and replaces the Genome-Wide Association Studies (GWAS) data sharing policy. A key tenet of the policy is the expectation that researchers obtain the informed consent of study participants for the potential future use of their de-identified data for research and for broad sharing. NIH has similar expectations for studies that involve the use of de-identified cell lines or clinical specimens.

NIH officials finalized the GDS policy after reviewing public comments on a draft released September 2013. Starting January 25, 2015, the policy will apply to all NIH-funded, large-scale human and non-human projects that generate genomic data. This includes research conducted with the support of NIH grants and contracts and within the NIH Intramural Research Program. A report from members of the NIH Genomic Data Sharing policy team appears in the August 27, 2014, advance online issue of Nature Genetics.