Professor Marc Rodwin calls for public access to clinical trial data

Do you and your doctor have sufficient information about drug risks to make wise choices? Should the U.S. follow Europe's lead, offering greater public access to clinical studies of drugs? Congressman Ed Markey and Suffolk Law professor Marc Rodwin believe public disclosure of clinical trial results constitutes a public good; the question is how much should be disclosed. Rodwin's recommendation appears in the Journal of the American Medical Association (JAMA).

The public -- including physicians and patients -- lack sufficient information about the results of clinical drug trials, contends Rodwin, an expert in health law and a fellow at the Edmond J. Safra Center for Ethics at Harvard.

Rodwin and JAMA essay co-author John D. Abramson, MD, of Harvard Medical School, recommend that clinical study reports (CSRs) be made accessible to the public, a move pharmaceutical companies have opposed. CSRs provide in-depth statistics and analysis of clinical trial data and are required by the FDA when it reviews new drugs. Europe recently agreed to make those reports public.

U.S. Rep. Edward Markey (D-MA) recently introduced a bill aimed at closing loopholes in a 2007 law that requires researchers to register their clinical trials on ClinicalTrials.gov. “The Markey bill and ClinicalTrials.gov are steps in the right direction. But they are insufficient,” says Rodwin.

"Disclosing CSRs would be a practical and inexpensive way to serve the public good," Rodwin says. "It's not a panacea, but it would cut down on the ease with which pharmaceutical companies can now withhold or spin clinical trial results."

According to Rodwin, ClinicalTrials.gov reports only basic clinical trial data, and lacks any means to check for accuracy or to assure compliance. The Markey bill would expand the type and level of clinical trials that should be registered, as well as the amount of data made available. But it does not provide the kind of detailed data found in CSRs.

"Accurate, complete data on clinical trials needs to be available so physicians, patients, hospitals, insurance companies, medical journals and medical schools can make evidence-based decisions," says Rodwin.