Clinical Trial Registries Becoming Global Standards

Three years after a group of leading medical journal editors pushed for clinical trial registration, public access to prospective clinical trial information has greatly improved. Not only has the U.S. government-funded online database ClinicalTrials.gov ballooned rapidly with new registrants, but the goal of worldwide centralization of databases seems within reach.

A number of factors led to the 2004 announcement by the 12 members of the International Committee of Medical Journal Editors (ICMJE). A flurry of revelations at the time indicated that pharmaceutical companies had been withholding negative clinical trial results from publication, including negative efficacy findings in antidepressant studies. This led to Congressional hearings and public pressure for increased transparency in reporting industry-sponsored clinical trials (Psychiatric News, October 15, 2004). Selective reporting of trials “distorts the body of evidence available for clinical decision making,” argued the members of the ICMJE in a joint editorial released in September 2004. Therefore, for any trial starting on or after July 1, 2005, these 12 journals required clinical trials to be registered in a publicly searchable database before or at patient enrollment as a condition for consideration for publication. This position quickly gained the support of organizations such as APA and the AMA. Many other biomedical journals, including American Journal of Psychiatry, went on to adopt the same policy. For sponsors and researchers, posting study protocols on a free, searchable online database may be useful for study recruitment.

At the urging of ICMJE, ClinicalTrials.gov, which is operated by the National Institutes of Health and accessible at<clinicaltrials.gov>, became open to all types of trials in October 2004, as sponsors and researchers in the United States and other countries rushed to register their trials. The online database was initially set up to post clinical trial information for all serious or life-threatening diseases, as required by the 1997 FDA Modernization Act, and all government-funded trials to allow patients and the public to search for and enroll in these trials.

The impact of ICMJE's policy was dramatic. The entries at ClinicalTrials.gov swelled from about 13,000 trials at the time of the ICMJE announcement to more than 40,000 in April as sponsors and researchers rushed to register their clinical trials, according to an update by the ICMJE in June.