To be sure, the road to clinical trials transparency is paved with good intentions—from the architects of http://www.clinicaltrials.gov//, to the sponsors, to the "external" stakeholders. But this road is proving to be a difficult one to travel.
Nicholas Ide, chief architect of http://www.clinicaltrials.gov/ and contractor to the National Library of Medicine, offered some insights into these difficulties at a Center for Business Intelligence (CBI) conference last month in London. The Clinical Trials Registries and Results Databases conference—the first held outside the United States—covered global and U.S. requirements.
Basic results reporting requirements went into effect September 27, 2008. As of last month, 250-plus results were submitted. Of those, approximately 46 had been "published" or made available on the site. So where are the balance of the results? Back to the sponsors for data clarification and cleanup.
"The data we have been getting is difficult to understand and the quality is pretty bad," Ide told the audience via teleconference. He provided actual examples of data errors, which are housed on the http://www.clinicaltrials.gov/ site.
However, one attendee responsible for transparency compliance at a large global pharma told Applied Clinical Trials that the company had submitted 40 results to the http://www.clinicaltrials.gov/ PRS database, and none have been approved.