Major Journals Expand Clinical Trial Public Registration Requirements
The International Committee of Medical Journal Editors (ICMJE) - which includes the editors of many of the world's best-known, prestigious medical research publications - recently announced an expansion of its 2005 policy requiring that clinical trial investigators and sponsors provide detailed information about their studies in a publicly accessible registry before the start of patient enrollment as a prerequisite for publication of the results in an ICMJE member journal.
The expanded policy was announced last month in an editorial in the ICMJE member publication New England Journal of Medicine. Effective July 1, 2008, the expanded policy for the first time requires registration of all studies designed to investigate a medical intervention on a health-related outcome, including phase I studies and phase II studies not covered by the earlier policy. Previously, phase I studies and phase II studies that lacked a comparison or control group were exempt from trial registration requirements.
"The ICMJE recognizes the potential benefit of having information about preliminary [phase I] trials in the public domain, because these studies can guide future research or signal safety concerns," noted the editors of the 12 ICMJE member journals, which also include the Journal of the American Medical Association, The Lancet, and MEDLINE, which is published by the National Library of Medicine.
When the ICMJE announced its original policy 2 years ago, requiring the registration of some phase II trials and all phase III and phase IV trials, it generated controversy and concern that the requirements would prove cumbersome or stifle competition. Since then, however, "the research community has embraced trial registration," the editors noted. Before the ICMJE policy, ClinicalTrials.gov, the largest trial registry at the time, contained 13,153 trials. In April 2007, the registry contained more than 40,000 trials, with more than 200 new trial registrations occurring weekly.
The ICMJE's trial registration requirements have been widely adopted by non-member medical journals. "We hope that [non-ICMJE journals] will also adopt the modifications discussed in this update," the editors wrote.
The requirements have caused many investigators and trial sponsors to request that the ICMJE recognize their local databases as registries in compliance with the registration policy. In response, the ICMJE has supported efforts by the World Health Organization (WHO), through the WHO International Clinical Trials Registry Platform (ICTRP), "to develop a coordinated process for identifying, gathering, de-duplicating, and searching trials from registries around the world." In addition to the five currently approved registries, the ICMJE will now also accept registration in any of the primary, nonprofit clinical trial registries that participate in the ICTRP.
NCI, through its Physician Data Query (PDQ®) Cancer Clinical Trials Registry, has also become an active participant in the worldwide clinical trials registration movement. PDQ works with ClinicalTrials.gov to ensure that NCI-sponsored trials are registered in that registry in compliance with ICMJE requirements. Furthermore, the PDQ registry is a partner register within the ICTRP Network of Collaborating Clinical Trial Registers; Lakshmi Grama of NCI's Office of Communications and Education, who manages the PDQ registry, has recently been appointed chair of the ICTRP Registers Working Group.