Medical reporters are likely familiar with ClinicalTrials.gov, the U.S. government-run registry of clinical trials. The site became available in 2000, three years after Congress passed the Food and Drug Administration Modernization Act of 1997 (FDAMA), which, as the site notes,
required the U.S. Department of Health and Human Services, through NIH, to establish a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug applications (IND) to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions.
The site – and others around the world – really took off in 2005 after the International Committee of Medical Journal Editors began requiring that researchers register their trials when they started if they wanted to publish the results. Publishing in the peer-reviewed literature is the coin of the realm in academia and also vital for FDA approval, so the carrot worked, according to a 2007 update:
Before the ICMJE policy, ClinicalTrials.gov, the largest trial registry at the time, contained 13 153 trials; this number climbed to 22 714 one month after the policy went into effect (3). In April 2007, the registry contained over 40 000 trials, with more than 200 new trial registrations occurring weekly (Zarin D. Personal communication).
Registration of a trial’s plans – what researchers plan to test, and how – also means there’s a pixel trail if reporters, or any member of the public, wants to see if scientists changed the goalposts to make their results look better, or buried negative results. (Also see Ghost protocols: Scientists propose a way to plug major holes in the medical literature)
Today, the site includes nearly 150,000 studies, along with a growing number of results, thanks to a 2007 act of Congress. As Robert Califf, Duke University’s vice chancellor of clinical and translational research, said earlier this month in a Friends of the National Library of Medicine-Research!America workshop on the registry:
It is difficult to claim you have created generalizable knowledge if you don’t share the trial data.
Failing to share those data “leads to unsuspecting human research participants being subject to risks that could have been avoided,” he added. (Worth noting, however: Some of the entries really mangle data entry, as this slide from ClinicalTrials.gov director Deborah Zarin shows. Participants in one study, for example, apparently slept more than 800 hours per day.)
So how can journalists bolster their reporting with the growing information available on ClinicalTrials.gov? After the Friends of the National Library of Medicine asked me to be on a panel with Califf at the workshop, I surveyed AHCJ members on how they use the site and what improvements they want to see. Those who responded include Ben Goldacre, Scott Hensley, Elaine Schattner, Matthew Herper, Brenda Goodman and others. Here’s my presentation summarizing the responses, which include everything from coming up with story ideas to a request that the site include a study’s informed consent forms: