Many of the most promising new medical treatments are just beyond the grasp of consumers simply because they don't know about them. But that's about to change. Beginning tomorrow, the nation's database for clinical trials, www.ClinicalTrials.com, will begin adding the results of trials of drugs, medical devices and biologic products (such as vaccines) conducted in the United States.
ClinicalTrials.com was launched in 2000 to provide people with easy access to information about clinical trials. But until now, consumers who went to the website could find only details about the trial's launch, such as the study's design and who is eligible to enroll. Under the new rule, researchers sponsoring the trial must go back and post their results (except for very early-stage experiments, which are called Phase 1 trials) online within one year of the study's conclusion or within 30 days of approval of a product by the Food and Drug Administration. The database will carry results of trials that were underway as of Sept. 27, 2007. However, researchers of previously completed trials have been encouraged to post their results, too.
The rule is a result of a law passed last year to demand more transparency in clinical trials. Consumer health advocates hope the requirement will make it harder for study sponsors to hide unexpected or harmful reactions to drugs or devices....
Comments
ClinicalTrials.COM is new, but ClinicalTrials.GOV is not. When Roan said that the .com version was launched in 2000, she must have meant the .gov version. Despite the plan to launch the .com version on September 27, it's still not open.
For more background on the new federal law requiring OA for clinical drug trial data, see our past posts on the FDA Amendments Act (FDAAA).
Update (9/29/08). Also see this September 26 announcement from the NLM, which describes an expansion of ClinicalTrials.gov but doesn't mention ClinicalTrials.com. The expansion will provide OA to results, or trial data themselves, not just to information about the trials.
Posted by
Peter Suber at 9/28/2008 10:18:00 AM.
The open access movement:
Putting peer-reviewed scientific and scholarly literature
on the internet. Making it available free of charge and
free of most copyright and licensing restrictions.
Removing the barriers to serious research.
I recommend the OA tracking project (OATP) as the best way to stay on top of new OA developments. You can read the OATP feed on a blog-like web page or subscribe to it by RSS, email, or Twitter. You can also help build the feed by tagging new developments you encounter.
