BioEd Online

Editors of the world's leading medical journals said yesterday that drug companies should disclose more information about studies of new medicines.

The editors' statement was released on 8 September, the day before a highly anticipated public hearing on clinical trial data at the US Congress. The hearing was prompted by concerns that publications about antidepressant drugs have underestimated the medicines' risks to children.

The journal editors say that they will now require companies to register a clinical trial in a public database before it starts if they hope to publish its final results. Trial leaders will need to describe the condition the trial aims to treat, which drug will be tested and how the trial will measure the success or failure of the drug.

The policy is intended to solve a problem that has long plagued medical research: if a drug fails in a clinical trial, a company gains little from publishing that result. So the published articles as a whole include many articles about a drug's success, but few about its failures. As a result, doctors get an unbalanced picture about the true effectiveness of drugs, the journal editors write in their statement.

Twelve international journals, including the New England Journal of Medicine, The Lancet, and the Journal of the American Medical Association, published the statement online.

"Unfortunately, selective reporting of trials does occur, and it distorts the body of evidence available for clinical decision-making," the editors write. "If all trials are registered in a public repository at their inception, every trial's existence is part of the public record, and the many stakeholders in clinical research can explore the full range of clinical evidence."

Taking responsibility

A handful of drug companies have recently announced plans to post the results of their clinical trials on their websites. And on 7 September, the pharmaceutical industry trade association, PhRMA, said it was planning to create a database where companies can choose to post clinical trial data.

But the journal editors' new rules require companies to go beyond these measures by registering every trial in a database run by a nonprofit organization, rather than a company. So far, only one firm, Merck & Company of Whitehouse Station, New Jersey, has pledged to post clinical trial information to a public database.

The pharmaceutical industry has been reluctant to publicize details of clinical trials because they could reveal trade secrets to competing companies. But Catherine De Angelis, editor of Journal of the American Medical Association, says the new rules are needed to ensure that physicians have complete information about the proper uses of drugs.

"As an editor, I feel responsible for providing physicians with the best available evidence so they can make a decision about the best patient care," De Angelis says. "Right now, I know I can't do that."