NIH Seeks Public Input on Expansion of the Clinical Trial Registry and Results Data Bank

The National Institutes of Health (NIH) will hold a public meeting and requests input from interested parties on issues that the agency will consider as it develops regulations to expand the clinical trial registry and results data bank commonly known as ClinicalTrials.gov. Effective clinical trials require the participation of all communities that will be served by the medical interventions tested. In return for their investment in clinical trials, participating communities should have reasonable access to trial results.

Improved access to trials results will promote greater community participation. We encourage you to respond to this NIH request by providing your input on how changes to ClinicalTrials.gov could help eliminate disparities in trial participation through facilitating better communication between investigators, sponsors, and community participants.

The public meeting will be held on Monday, April 20, 2009 from 9 a.m. to 5 p.m. The meeting will be held in Masur Auditorium, which is located on the NIH Campus, Building 10, South Side, First Floor, 10 Center Drive, Bethesda, Maryland 20892. Participants wishing to make an oral statement at the Public Meeting are requested to register online and to submit to the meeting docket a written version of their remarks by 5:00 p.m. on Monday, April 13, 2009. If you can't attend the meeting, we encourage you to provide comments for the public record. Submit electronic comments to Docket No. NIH-2009-0002 at: http://www.regulations.gov. To ensure consideration, written comments should be submitted to the docket by Monday, June 22, 2009. The FR Notice includes 11 detailed questions for which NIH is seeking input. The questions include issues related to unapproved products, narrative summaries, plain language, complete protocol submissions, quality control, timing for submission of results and updates, adverse events, and voluntary submissions.

The Federal Register Notice can be viewed at:
http://edocket.access.gpo.gov/2009/pdf/E9-6198.pdf
You may also view the meeting remotely via live videocast at: http://videocast.nih.gov.