policy

New Search Feature for FDA Guidance Documents

Posted on by Gina Uhlenbrauck

A new feature on the FDA.gov website allows you to search for FDA guidance documents on all topics from one convenient location:

FDA Guidance Document Search Feature

Guidance documents represent the FDA’s current thinking on particular topics and are used by stakeholders to understand the agency’s interpretation of regulations and policies.

There are approximately 3,000 guidance documents available on the site, which can be searched by keyword or filtered by date issued, FDA organizational unit, subject, draft or final status, and comment period.

The search feature was implemented in January 2015 in response to site visitor feedback.

Comment Period Extended for NPRM: Transparency of Clinical Trial Results

Posted on by Gina Uhlenbrauck

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.

RELATED LINKS 

ClinicalTrials.gov

JAMA Viewpoint: Sharing and Reporting the Results of Clinical Trials

 

NIH Issues Draft Policy Proposing Use of Single IRB for Multisite Clinical Research Studies

Posted on by Gina Uhlenbrauck

On December 3, 2014, the National Institutes of Health (NIH) issued a draft policy promoting the use of a single institutional review board (IRB) for multisite studies. IRBs play a critical role in assuring the ethical conduct of research, and studies must be reviewed and approved by an IRB before they can begin. Yet over time, the clinical research landscape has become increasingly complex, expanding from studies formerly conducted at single institutions to large, diverse studies across networks and multiple sites. This situation challenges the practicality of using local IRBs to conduct initial and ongoing reviews for such studies.

The goal of permitting use of a single IRB—also called a central IRB or IRB of record—is to enhance and streamline the process of IRB review for multisite studies so that research can proceed efficiently without compromising ethical principles and protections. While both the FDA and Office for Human Research Protections support the use of a single IRB, too few institutions involved in multisite studies are taking advantage of the option.

 Read the NIH draft policy here.

“By using single IRBs in multi-site studies, we reduce duplication of effort, speed the initiation of important research, and save time and taxpayer funds.”
Francis S. Collins, MD, PhD, NIH Director

Among the current NIH programs incorporating the use of a single IRB are:

  • National Cancer Institute’s Central Institutional Review Board (CIRB)
  • National Institute of Neurological Disorders and Stroke’s Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT)
  • Network for Stroke Research (NIH StrokeNet)

Dr. Sally Rockney, NIH deputy director for extramural research, explains the NIH perspective in her blog. Public comment on the draft policy extends for 60 days, through January 29, 2015. When finalized, the policy will apply to all NIH-funded multisite studies carried out in the United States, whether supported through grants, contracts, or the NIH intramural program.