Clinical Trials Reporting and Publication (CRS Report for Congress)
| Release Date |
Revised Feb. 14, 2005 |
| Report Number |
RS21944 |
| Report Type |
Report |
| Authors |
Erin Williams and Susan Thaul, Domestic Social Policy Division |
| Source Agency |
Congressional Research Service |
| Older Revisions |
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Premium Sept. 23, 2004 (5 pages, $24.95)
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Summary:
The recent focus on public access to pediatric clinical trial data for certain selective serotonin reuptake inhibitors (SSRIs) and other antidepressants has highlighted the issues surrounding public access to clinical trial data generally. Clinical trials data are central to assessing drugs effectiveness, yet there is no centralized system for reporting results. Due to medical journal practices and drug sponsor and researcher incentives to publicize positive results, many trials are never publicly reported. Although Food and Drug Administration (FDA) regulations require applicants to register clinical trials at clinicaltrials.gov, not all trials are listed there. Several groups have called for public access to standardized clinical trials data, including notice trial launch and research results. In October 2004, Representative Edward Markey and Senator Christopher Dodd introduced companion bills H.R. 5252 and S. 2933, the Fair Access to Clinical Trials Act, which would have required registration of clinical trials before the enrollment of human subjects, and the subsequent posting of results, at clinicaltrials.gov or a similar forum. Similar legislation is likely to be introduced in the 109th Congress.
