Leading Medical Journals Toughen Requirements for Publication

In a bold undertaking, the editors of some of the world's most prestigious peer-reviewed medical journals announced in September that they will“ require, as a condition of consideration for publication, registration in a public trials registry” for all articles written about clinical trials. The announcement moves an APA goal one step closer to fruition.

The group of 11 editors, known as the International Committee of Medical Journal Editors (ICMJE), said that for any clinical trial that starts enrollment after July 1, 2005, the trial must register “at or before the onset of patient enrollment.” For trials that begin enrollment prior to that date, registration will be required as a condition of consideration for publication as of September 13, 2005.

“In return for the altruism and trust that make clinical research possible,” the ICMJE editors (see box below) wrote, “the research enterprise has an obligation to conduct research ethically and to report it honestly. Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavorably on a research sponsor's product.

“Unfortunately,” the editors continued, “selective reporting of trials does occur, and it distorts the body of evidence available for clinical decision making.”

The ICMJE defined a clinical trial as “any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.”

The ICMJE did not dictate trial registration in a specific registry, instead delineating the principles it believes a registry should meet. The registry should be independently managed by a nonprofit organization and must be open to all registrants and freely accessible to the public. In addition, the editors said, there must be some mechanism for ensuring the validity of the information, and the database should be electronically searchable. The editors also created a comprehensive list of minimal data that should be contained in the registry record.

Currently, the only clinical trials database that will satisfy the ICMJE requirements is the National Library of Medicine's<www.clinicaltrials.gov>. In recent months, several pharmaceutical companies said they will begin listing their clinical trials data on their own Web sites. Last month, during a congressional hearing on alleged withholding of negative clinical trials data involving antidepressants, the drug industry's trade group, the Pharmaceutical Research and Manufacturers of America, announced it would develop an online registry “to improve the transparency of the drug development process.”

In addition, several members of the House of Representatives and Senate have announced that they are working to introduce legislation mandating a federally administered clinical trials registry.

All of the current efforts follow the advocacy efforts of APA and the American Academy of Child and Adolescent Psychiatry (AACAP). In June 2003 APA and AACAP jointly introduced a resolution at the AMA's House of Delegates asking the AMA to support and advocate for a registry. That resolution led to a report on the issue by the AMA's Council on Scientific Affairs. Last June, an APA/AACAP joint resolution was finally approved, cementing AMA's support of a formal clinical trials registry.

As this article went to press, the editorial board of the American Journal of Psychiatry was expected to review the ICMJE statement. While AJP and the other journals published by American Psychiatric Publishing Inc. are not members of ICMJE, the journals have historically conformed to ICMJE policy.

The ICMJE's statement on clinical trials registry can be accessed online at<www.icmje.org> by clicking on “Clinical Trials Registry” under “ICMJE Editorials.” ▪