International Committee of Medical Journal Editors updates requirements for clinical trials registry

The International Committee of Medical Journal Editors (ICMJE) today issued a follow-up joint editorial regarding its goal to foster a comprehensive, publicly available database of clinical trials. The joint editorial by 11 ICMJE member journals is published online simultaneously today and is posted on the JAMA website. It will also appear in print in the June 15 issue of JAMA.

The current joint editorial is an update and clarification of several points made in the ICMJE joint editorial published in September 2004. The first joint editorial stated that the journals "will consider a trial for publication only if it has been registered before the enrollment of the first patient. This policy applies to trials that start recruiting on or after July 1, 2005. Because many ongoing trials were not registered at inception, we will consider for publication ongoing trials that are registered before September 13, 2005."

Since the ICMJE statement in September, many other journals have joined this effort and the U.S. Congress is considering legislation, the proposed Fair Access to Clinical Trials (FACT) Act that would expand the current mandate for registration of clinical trials. The journal editors are working with the World Health Organization (WHO) toward "the goal of a single worldwide standard for the information that trial authors must disclose." The table in this editorial lists the required items that must be contained in the clinical trials registry.

The editors define a clinical trial as: "Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome." In an update to their 2004 definition, the editors add: ". that a trial must have at least one prospectively assigned concurrent control or comparison group in order to trigger the requirement for registration." The journals would "require registration of all trials whose primary purpose is to affect clinical practice (phase 3 trials)."

The ICMJE members restate their requirements: "The registry must be electronically searchable and accessible to the public at no charge. It must be open to all registrations and not for profit. It must have a mechanism to ensure the validity of the registration data."

"The purpose of a clinical trials registry is to promote the public good by ensuring that everyone can find key information about every clinical trial whose principal aim is to shape medical decision-making. We will do what we can to help reach this goal. We urge all parties to register new and ongoing clinical trials."