Public Meeting Scheduled for Clinical Trial Regulations

A public meeting to gather input on updated regulations expanding clinical trial registration and results reporting through NLM’s ClinicalTrials.gov system has been slated for April 20. It will take place in the Masur Auditorium, on the NIH Campus, and will also be available via the NIH Videocast Web site.

Results from clinical trials provide important links that are integrated into the clinical trial records and can be accessed through MedlinePlus. Expansion of clinical trial registration and results reporting was mandated by amendments in 2007 to the Food and Drug Administration Act. Since 2000, the clinical trials database has provided patients, families and the public easy access to a clinical trial’s purpose, who may participate, locations, and contact information.

The NIH has also opened a public docket for written comments on topics to be addressed at the meeting. Further information about the meeting and the request for public comment can be found in the Federal Register notice and at PRS Information: U.S. Public Law 110-85 on the ClinicalTrials.gov Web site.