1 Boring Old Man

Despite Law, Fewer Than One In Eight Completed Studies Of Drugs And Biologics Are Reported On Time On ClinicalTrials.gov
Health Affairs
by Michael R. Law, Yuko Kawasumi and Steven G. Morgan
December 2011

^{Clinical trial registries are public databases created to prospectively document the methods and measures of prescription drug studies and retrospectively collect a summary of results. In 2007 the US government began requiring that researchers register certain studies and report the results on ClinicalTrials.gov, a public database of federally and privately supported trials conducted in the United States and abroad. We found that although the mandate briefly increased trial registrations, 39 percent of trials were still registered late after the mandate’s deadline, and only 12 percent of completed studies reported results within a year, as required by the mandate. This result is important because there is evidence of selective reporting even among registered trials. Furthermore, we found that trials funded by industry were more than three times as likely to report results than were trials funded by the National Institutes of Health. Thus, additional enforcement may be required to ensure disclosure of all trial results, leading to a better understanding of drug safety and efficacy. Congress should also reconsider the three-year delay in reporting results for products that have been approved by the Food and Drug Administration and are in use by patients.}

Hat Tip to Pharmalot  

I’d like to add a resounding second to the request that clinicaltrials.gov needs policing. In looking into the pharmaceutical story, there are some indispensable tools…

… and clinicaltrials.gov is perhaps the most important, and definitely the most neglected. Not only are there late filings, there’s plenty else to complain about. There’s a section, History of Changes, that often really matters and it’s updated sporadically and not necessarily at the time of the changes themselves. Something else very annoying and way outside the purpose of the site – they’ve started hiding the clinical research centers’ identities in many drug sponsored trials: