Corporate Financed Clinical Trials Stifle Important Data

The current system of financing clinical trials for prescription drugs and medical devices, which relies primarily on corporate funding, makes little useful information available to researchers and practitioners. Limiting the availability of data on how various demographic groups performed in trials is denying practitioners and researchers access to information that would allow better prescribing practices and lead to the development of better drugs.

That's the conclusion from research published in, "The Availability of Data from Clinical Trials: The Case of Crohn's Disease," released today by the Center for Economic and Policy Research (CEPR). "The lack of transparency surrounding drug safety and efficacy data is an enormous loss to potential users of data, either clinicians or other investigators," said Ravi Katari, M.D., co-author of the report.

The study examines the data from 53 clinical trials related to Crohn's disease that were listed in Clinicaltrials.gov. There was virtually no information on outcomes in the Clinicaltrial.gov data. These trials led to 32 published journal articles. In only five of these articles was there any information on how various demographic groups (e.g., men versus women) had performed. When authors were contacted to obtain data, in only one case was it indicated that the data would be available for further analysis.

Clinical trials, which evaluate prescription drugs and new devices before their entrance on the market, are usually financed (and sometimes even carried out) by the company holding the intellectual property rights to the technology in question. There is an obvious incentive to conceal or underreport trial data which could be harmful to a drug's sales potential or reputation.

"The costs of additional disclosure should be trivial. The potential health benefits are enormous," said senior economist Dean Baker, another of the report's co-authors.

The report recommends the government require full and timely disclosure of test results for any study receiving any form of government funding. The government could also take the lead and make these disclosures for the studies it conducts itself. Ideally, full disclosure would become the norm so that even studies that are financed entirely by the private sector would follow this practice.