Drug-Industry Database Will Let Doctors, Consumers Search Trial ResultsDrug-Industry Database Will Let Doctors, Consumers Search Trial Results

The pharmaceutical industry is establishing an online database of clinical trial results of drugs marketed in the United States. But the database, which will offer only summary data from voluntarily participating drugmakers, may not be enough to meet the demands of doctors and other industry critics who say pharmaceutical makers need to disclose more information about drug tests.

On Tuesday, the Pharmaceutical Research and Manufacturers of America, the industry's Washington-based trade group, said the database (www.clinicalstudyresults.org) will hold summarized results--both positive and negative--of controlled clinical test results completed since October 2002 for drugs approved for marketing in the United States by PhRMA member companies. The database, to be operational Oct. 1, will let doctors and consumers search drug-test results by drug name, manufacturer, and disease.

The database will include both published and unpublished summarized test results of late-stage clinical tests, plus other information, such as how the tests were designed, the number of participating patients, drug-label information, and bibliographies of articles published about the drug being tested. But the database won't provide raw data from the clinical studies or test data on drugs still under development. It also won't include information from some early-stage drug tests.

PhRMA's move is in response to calls by doctors and medical journal editors for the creation of a mandatory central clinical trial registry for all drug-trial data. Pharmaceutical-industry critics say drugmakers don't disclose information about potential problems with their products. Last month, GlaxoSmithKline plc settled a lawsuit brought by New York Attorney General Eliot Spitzer that charged the company with withholding information about possible adverse effects of its Paxil antidepressant drug on teenagers.

Dr. Paul Antony, PhRMA's chief medical officer, said in a press conference Tuesday that the PhRMA database will provide summarized data to make it easy for doctors and consumers to use. "As a practicing physician, I don't have the time to slog through hundreds, perhaps thousands of pages of raw clinical trial data," he said.

PhRMA executives did not name specific drugmakers they expect to post data to the database. But Dr. Caroline Lowe, PhRMA's VP for scientific and regulatory affairs, said the organization's members back the project and many are expected to participate. PhRMA members include such industry heavyweights as Eli Lilly, Merck, and Pfizer.

PhRMA hopes to eventually turn operation of the database over to a third-party organization, Lowe said, but it hasn't determined who that might be.

Some pharmaceutical companies have taken their own steps to publish clinical trial data. Last week, GlaxoSmithKline began posting on the Web summary results of GlaxoSmithKline-sponsored trials of its medications. The first posted data concerns clinical trials of Avandia, a drug for type-2 diabetes.

Early last month, Merck said it would post test data on a Web site run by the National Institutes of Health. That Web site provides prospective test subjects with information about ongoing drug trials. But some have suggested expanding its scope to include all clinical trial data.

Such data already posted elsewhere might also be posted on the PhRMA site, Lowe said, or the PhRMA site might include links to other sites.