...Now [after the Avandia controversy] Congress, scientists and advocacy groups want to open up the world of [drug] trials in hopes of heading off problems with new drugs sooner.
"Human subject research is only ethical if it is used to advance science, not the interests of a particular company," said Sean Hennessy, an epidemiology professor at the University of Pennsylvania medical school....
Although there is wide agreement that the system for reporting on clinical trials needs an overhaul, there are sharp disagreements on just how to do it....
For one thing, there is no central, easily searchable database to which drug makers are required to post all trial results....
[S]ince most decisions on drug safety involve balancing benefits against risks -- almost no drug is 100% safe -- making it easier to examine clinical trial data helps patients and doctors decide whether a drug is right for a particular situation....
The dispute is over how to publish the results of trials.
The House bill directs the NIH to set up a database showing results in addition to the current clinical trials registry. The results database would include a nontechnical summary of each clinical trial and its outcome, as well as basic technical findings on effectiveness and safety that are of interest to researchers and regulators.
Results would have to be posted within 12 months after the research is finished.
The Senate bill does not lay out such a specific blueprint. Instead, it directs the NIH to conduct a feasibility study on how to set up the results database. The agency would have to seek input from all interested parties, including industry, the medical community and advocates for patients. Under the legislation, that process could take up to 2 1/2 years.
"The House version is likely to lead to a pretty good database quite quickly, whereas it's much less clear with the Senate version," said Peter Lurie, deputy director of the Public Citizen Health Research Group. "The concern is that the Senate version will lead to a kind of purgatory in which the database is promised but never emerges in a useful form." ...
Posted by
Peter Suber at 9/18/2007 08:08:00 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.
