Clinical Trial Registration

Clinical Trial Registration
Looking Back and Moving Ahead
Christine Laine, MD, MPH; Richard Horton, FMedSci; Catherine D. DeAngelis, MD, MPH; Jeffrey M. Drazen, MD; Frank A. Frizelle, MBChB, MMedSci; Fiona Godlee, MBBChir, BSc; Charlotte Haug, MD, PhD, MSc; Paul C. Hébert, MD, MHSc; Sheldon Kotzin, MLS; Ana Marusic, MD, PhD; Peush Sahni, MS, PhD; Torben V. Schroeder, MD, DMSc; Harold C. Sox, MD; Martin B. Van Der Weyden, MD; Freek W.A. Verheugt, MD
JAMA. 2007;298:(doi:10.1001/jama.298.1.jed70037).
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 http://www.icmje.org/), but many other journals have adopted our initial trial registration recommendations, and we hope that they will also adopt the modifications discussed in this update.