FDA, NIH Failed to Publish Clinical Trial Data

Three major Democratic Congressmen wonder why organizations and scientists who manage clinical trials are consistently failing to submit final outcomes data on ClinicalTrials.gov as needed by the 2007 FDA reform law. A sequence of articles in January in the British Medical Journal identified that only 22 percent of 738 trials documented in 2009 had outcomes details.

FDA Commissioner Margaret Hamburg and Director Francis Collins NIH, Henry Waxman and Edward Reps. region of Marche and Diana, all Democrats, in a letter, the number of government officials when the exact results and whether the Agency was fined any of the companies or not posting the information on the results of their researchers. Sponsors of research might be fine up to $ 10,000 per day of non-reporting of results.

Why is this so essential? Clinical trial providers must log on to ClinicalTrials.gov before beginning a trial if they want to publish final results in any of the leading medical journals. Journal editors demanded to check in advance of publication as part of the peer review.

Letter from Waxman et al for the FDA yesterday is an appropriate coda former FDA Commissioner Andrew Van Eschenbach proposal in the Wall Street Journal yesterday that new drugs or devices shall be approved after phase I safety trials. Evidence of effectiveness may come later, suggested based on data obtained from the registers.