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Leading medical journals to require clinical trial registration as prerequisite for publication

September, 2004 -- Eleven prestigious medical journals around the world have announced a new strategy intended to force drug companies to disclose more information about clinical trials.

The International Committee of Medical Journal Editors (ICMJE) plans to refuse to publish papers on clinical trial results if the trial was not recorded in a publicly-accessible registry at its outset. The new policy will be brought into force over the next year. The group of journals involved includes the New England Journal of Medicine, The Lancet, and The Journal of the American Medical Association. Read the commitee's full statement...

These registries would describe the size, design and purpose of each trial at its beginning. The policy's aim is to prevent companies from only reporting positive results, or spinning data to suppress inconclusive or unflattering conclusions about their treatments, says Catherine De Angelis, editor-in-chief of JAMA.

All the editors had had stories about clinical results being brought into question "because we knew there were trials out there that were never being reported", she says. While there are hundreds of other medical publications that have not publicly endorsed the plan, De Angelis believes many will. "We already know of several other journals that are going to sign on."

"This is a really exciting development. This will be a motivator for companies, no doubt about it," says Kay Dickersin of the Brown University Center for Clinical Trials and Evidence-based Healthcare in Providence, Rhode Island. But experts like Dickersin also say greater steps are needed to guarantee that the public gets the information it needs.

High profile lawsuit

For years, medical advocates have been calling with little effect for biotech and pharmaceutical companies to provide more details about their clinical results. But recently, the issue has been reinvigorated, partly due to the high profile lawsuit brought by New York State attorney general, Eliot Spitzer, against the pharmaceutical giant GlaxoSmithKline.

The suit alleged that the company withheld trial data suggesting that children taking its antidepressant drug Paxil had more suicidal tendencies than children receiving placebos. While the company admitted no wrongdoing, it has agreed to pay a $2.5 million dollar settlement and to post more comprehensive trial results on its website.

As a result, other industry leaders, such as Eli Lilly and Merck announced they would also start registering their results online. And just this week, the Pharmaceutical Research and Manufacturers of America, an industry trade group to which all three companies belong, announced the creation of a database in which its member companies would voluntarily deposit both negative and positive results.

However, an important element of the plan the ICMJE endorses is the requirement that such registries be run by not-for-profit agencies with standards for the validity of the data they contain. The editors cite the database maintained by the US National Library of Medicine as an exemplar.

Volunteer, industry-sponsored substitutes will not work, says De Angelis. "Why would you put the fox in charge of the hen house?" she says. "And if they have nothing to hide, why waste money setting up their own database?"

Source: news service

Posted: September 2004