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05/02/2012

Registration of Trials: A Census

Apologies to the millions of avid followers of Lost in Translation for the long haitus.  In response to an international petition campaign, with several Nobelist signatories, I am cautiously restarting this blog with the aim of (monthly??) blogposts on troubles and turmoil in clinical translation.

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)

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