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Clinical trial registration: looking back and moving ahead

Christine Laine, Richard Horton, Catherine De Angelis, Jeffrey M Drazen, Frank A Frizelle, Fiona Godlee, Charlotte Haug, Paul C Hébert, Sheldon Kotzin, Ana Marusic, Peush Sahni, Torben V Schroeder, Harold C Sox, Martin B Van Der Weyden and Freek W A Verheugt
Med J Aust 2007; 186 (12): 612-613.
Published online: 18 June 2007

An update on the requirements of ICMJE’s clinical trial registration policy

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 enrolment.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 re-evaluate the policy 2 years after implementation. Here, we summarise that re-evaluation, 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.

  • Christine Laine
  • Richard Horton
  • Catherine De Angelis
  • Jeffrey M Drazen
  • Frank A Frizelle
  • Fiona Godlee
  • Charlotte Haug
  • Paul C Hébert
  • Sheldon Kotzin
  • Ana Marusic
  • Peush Sahni
  • Torben V Schroeder
  • Harold C Sox
  • Martin B Van Der Weyden
  • Freek W A Verheugt


Correspondence: medjaust@ampco.com.au

Competing interests:

Fiona Godlee was previously editorial director of Clinical Controlled Trials, which owns the ISRCTN (International Standard Randomised Controlled Trial Number) trials register; she has also provided expert testimony. Sheldon Kotzin is employed by the National Library of Medicine, which produces ClinicalTrials.gov, but he is not responsible for activities or policies regarding ClinicalTrials.gov. Richard Horton is Co-Chair and Jeffrey Drazen and Harold Sox are members of the WHO ICTRP Scientific Advisory Group. Martin Van Der Weyden is a member of the government advisory committee for the Australian and New Zealand Clinical Trials Registry.

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