Kate Fodor, Trials of the Pharmaceutical Industry, The Scientist, November 22, 2004. Excerpt: 'Pharmaceutical companies may soon be required to register their clinical trials and publicly disclose the results, whether they show a drug in a positive, negative, or lukewarm light....In early October, citing the [GlaxoSmithKline Paxil] case as an impetus, a group of lawmakers introduced the Fair Access to Clinical Trials (FACT) Act, which is an effort to increase the transparency of clinical trials for drugs, biologics, and medical devices....The 48-page bill calls for a mandatory, electronic clinical-trial registry to be run by the government. The bill would require companies to post information about a study before patient enrollment begins and to publish a summary of the results --whether positive, negative, or inconclusive-- once the study is complete. The registry would operate as an expansion of [open-access] clinicaltrials.gov, which houses a database established in 1997 that is run by the government's National Library of Medicine. Currently, only studies of drugs for serious diseases must be registered in the database, and companies are not required to provide results of the trials. The FACT Act would require all US Phase II, III, and IV trials to be registered, with updates provided every six months until a summary of the final results is posted. Study sponsors who fail to comply would face civil penalties of up to $10,000 per day and would be ineligible to receive government grant money or contracts.' The rest of the article contains a detailed overview of drug company concerns and legislative responses.
(PS: The FACT Act has been introduced in both houses of Congress. The House bill is H.R.5252. The Senate bill is S.2933.)
Posted by
Peter Suber at 11/19/2004 01:25:00 PM.
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.
