looks like the ama will succeed with a big push for a new “HHS Clinical Trials” database….in june, circa 540 american medical association members at the annual meeting unanimously approved a resolution urging the us department of health and human services to create a national database for all clinical trials and their outcomes…here’s the link to the ama release from june 15th ….ama stated that, “Journals are more interested in publishing studies that are likely to affect clinical practice. As a result, confirmatory trials, trials with negative results, and trials that show no significant result are less likely to be published…new policies were based on…AMA’s Council on Scientific Affairs (CSA). “…a little follow-up note from the ama on june 18th shows positive signs…and it got even more steam just a few days ago, june 24th, when “Several members of Congress indicated interest in pursuing legislation to create the registry”

okay, this is huge news for researchers working in or around the world of pharma (!).. i remember what a pain it was ten years ago when i used to have call phrma to request all sorts of manufactured drug data from the librarians and researchers on staff. all were incredibly helpful, don’t get me wrong - just a lot of slow faxing and incomplete data depending on stage of trial, data slices used for reports and so on…i usually wound up making another ten phone calls to expound details until my ear was all clammy… but NOTE this: success remains to be seen. this is in the best interest of the public (duh), and while companies like glaxo (denying charges that they withheld details on paxil) and merck (one company that is bigger than the entire biotech industry rolled up) are publicly taking the high ground embracing this, according to new scientist , “merck doesn’t want details for smaller trials to be routinely included - only the large, pivotial trials” (6/26 issue, page 5)

lemme explain the precise significance of this for those who might not completely get it: currently, drug companies must submit all clinical trial results to FDA, but the FDA is prohibited from disclosing all information (because some is considered proprietary) …”In some rare instances, FDA officials can publicize information if they deem it necessary for the public to know” (Boston Herald, 6/16). …”In addition to changing FDA policy and creating a public federal database for all clinical studies, the resolution recommends that research review boards at hospitals, universities and medical centers mandate registration as a condition of approval” (e.g. for publication in journals, etc) (New York Times, 6/16). …resolution also suggests that institutional review boards, which monitor participants in clinical trials, require registration in the federal database before allowing studies to proceed - now that’s a way to put a fire under their collective asses, huh?

this might very well put many pharma related monitoring services groups (within the world of competitive intelligence and market research) between a rock and a hard place - akin to what has happened to all of those news clipping services trying to prove their relevance in a world of automated alerts, rss feeds and other…

a very detailed, comprehensive multi-source overview of this entire issue can be found at the california healthcare foundation’s website (you’ll need to register for free to view this article, it’s worth it if this is of real interest to you)

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