Wednesday, May 2, 2012
Registration of Trials: A Census
We lead off with an article in this week's JAMA, led by Robert Califf, which provides a census of the clinical research enterprise through an analysis of registered trials at clinicaltrials.gov. As with many such surveys of clinicaltrials.gov, the picture w/ respect to registry compliance ain't pretty. Some particularly troubling highlights: the proportion of trials that were registered AFTER beginning enrollment was 52% between Oct 2007 and Sept 2010, and 6.8% of trials do not report their primary purpose (as required).
More generally, Califf et al finds 62% of registered trials are drug trials (the remainder involve procedures, diet, etc.); 63% involve North American research sites; 32% are industry sponsored; 15% are phase 3.
There are some interesting tidbits buried here. For instance, many commentators are critical of phase 4 studies- viewing many such studies as trials aimed primarily at marketing (phase 4 trials test drugs that have already received regulatory approval for marketing). Califf et al find that phase 4 studies are significantly less likely to report using blinding compared with phase 3.
The commentary by Dickersin and Rennie makes for a riveting read for those interested in the broader clinical research enterprise. (photo credit: D. Clow 2008)
Posted by Jonathan Kimmelman at 2:34 PM