LAURAN NEERGAARD,AP Medical Writer
Government Proposes Rules for Trial Transparency
WASHINGTON (AP) — The government proposed new rules Wednesday to make it easier for doctors and patients to learn if clinical trials of treatments worked or not.
Role of Clinical Trials in Health Research
Thousands of Americans participate in clinical trials every year, testing new treatments, comparing old ones or helping to uncover general knowledge about health. Many of the studies are reported in scientific journals and trumpeted in the news. But results aren’t always made public, especially studies that fail.
NIH Plans Mandatory Results Disclosure
National Institutes of Health Director Francis Collins says that’s not acceptable. Under the new proposals, all clinical trials funded by NIH would have to reveal summaries of their results on a public database: www.clinicaltrials.gov . So would certain other studies under an expansion of Food and Drug Administration rules.
Public Comment Period and Next Steps
The proposals are open for public comment through Feb. 19.
