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Clinical Trial Registration: Looking Back and Moving Ahead
- Christine Laine, MD, MPH;
- Catherine De Angelis, MD, MPH;
- Tony Delamothe, MD;
- Jeffrey M. Drazen, MD;
- Frank A. Frizelle, MBChB, MMedSc;
- Charlotte Haug, MD, PhD, MSc;
- Paul C. Hébert, MD;
- Richard Horton, FMedSci;
- Sheldon Kotzin, MLS;
- Ana Marusic, MD, PhD;
- Peush Sahni, MD;
- Torben V. Schroeder, MD, DMSc;
- Harold C. Sox, MD;
- Martin B. Van Der Weyden, MD; and
- Freek W.A. Verheugt, MD
Key Summary Points
In addition to accepting registration in any of the 5 existing registries, the ICMJE will accept registration of clinical trials in any of the primary registers that participate in the WHO ICTRP. Registration in a partner register only is insufficient.
The ICMJE will begin to implement the WHO definition of clinical trials for all trials that begin enrollment on or after 1 July 2008. This definition states that a clinical trial is “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”
The ICMJE will not consider results posted in the same clinical trials registry in which the primary registration resides to be previous publication if the results are presented in the form of a brief, structured (<500 words) abstract or table.
In 2005, the International Committee of Medical Journal Editors (ICMJE) initiated a policy requiring investigators to deposit information about trial design into an accepted clinical trials registry before the onset of patient enrollment (1). This policy aimed to ensure that information about the existence and design of clinically directive trials was publicly available, an ideal that leaders in evidence-based medicine have advocated for decades (2). The policy precipitated much angst among research investigators and sponsors, who feared that registration would be burdensome and would stifle competition. Yet, the response to this policy has been overwhelming. The ICMJE promised to reevaluate the policy in 2 years after implementation. Here, we summarize that reevaluation, specifically commenting on registries that meet the policy requirements, the types of studies that require registration, and the registration of trial results. As is always the case, the ICMJE establishes policy only for the 12 member journals (a detailed description of the ICMJE and its purpose is available at …
This 100-word excerpt has been provided in the absence of an abstract.
