Wednesday, September 26, 2012
In 2007, motivated by concerns that pharmaceutical companies were not sharing negative data about what had been learned in clinical trials, Congress established enhanced reporting requirements, http://prsinfo.clinicaltrials.gov/s801-fact-sheet.pdf.
A series of articles published in January 2012 in the British Medical Journal demonstrates that data reporting remains deeply problematic, especially for industry-sponsored trials. (The articles can be found at http://www.bmj.com/content/344/bmj.d8013?tab=related and are very much worth reading).
A posting Sept. 26 in the Federal Register indicates that the Secretary of HHS has delegated authority to to oversee the reporting process to the FDA, https://s3.amazonaws.com/public-inspection.federalregister.gov/2012-23598.pdf. Whether this signals improved monitoring of clinical trial data submissions remains to be seen, http://www.pharmalot.com/2012/09/fda-gets-new-authority-over-clinical-trial-reporting/. One can only hope.