In testimony submitted to the National Institutes of Health (NIH) today, the Biotechnology Industry Organization (BIO) stressed the commitment of its member companies to help ensure that patients and health care providers have access to key clinical trial results information from trials of unapproved products.
“BIO supports efforts to increase the availability of accurate, reliable, scientific evidence to inform clinical decision-making,” stated BIO President and CEO Jim Greenwood. “We believe that individual patients, clinical decision-makers and scientific researchers should be armed with the best available information to help assess the relative clinical benefits and risks of treatment options.”
The Food and Drug Administration Amendments Act (FDAAA) directs NIH to address whether or not results of clinical trials should be disseminated if the drugs studied in the trial are unapproved. BIO's testimony today was part of a public meeting required to be held to address this and other questions regarding public disclosure of clinical trial results.
In testimony, BIO reiterated its support for FDAAA’s goal to, “provide more complete results information and to enhance patient access to and understanding of the results of clinical trials.” BIO noted that disseminating certain additional trial result information may reduce duplicative studies, which divert industry resources that could be used to undertake innovative research, and could also alleviate pressures on the Food and Drug Administration’s review resources....
Posted by
Peter Suber at 5/04/2009 12:38:00 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.
