Editorials

Clinical trial registration

BMJ 2007; 334 doi: https://doi.org/10.1136/bmj.39233.510810.80 (Published 07 June 2007) Cite this as: BMJ 2007;334:1177
  1. Christine Laine, senior deputy editor, Annals of Internal Medicine,
  2. Richard Horton, editor, Lancet,
  3. Catherine D DeAngelis, editor-in-chief, JAMA,
  4. Jeffrey M Drazen, editor-in-chief, New England Journal of Medicine,
  5. Frank A Frizelle, editor-in-chief, New Zealand Medical Journal,
  6. Fiona Godlee, editor-in-chief, BMJ,
  7. Charlotte Haug, editor-in-chief, Norwegian Medical Journal,
  8. Paul C Hébert, editor-in-chief, CMAJ,
  9. Sheldon Kotzin, executive editor, MEDLINE, National Library of Medicine,
  10. Ana Marusic, Editor, Croatian Medical Journal,
  11. Peush Sahni, representative and past president, World Association of Medical Editors,
  12. Torben V Schroeder, editor, Journal of the Danish Medical Association,
  13. Harold C Sox, editor, Annals of Internal Medicine,
  14. Martin B Van Der Weyden, editor, Medical Journal of Australia,
  15. Freek W A Verheugt, executive editor, Nederlands Tijdschrift voor Geneeskunde (Dutch Journal of Medicine)
  1. claine{at}mail.acponline.org

    Looking back and moving ahead

    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 two 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 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.

    The research community has embraced trial registration. Before the ICMJE policy, ClinicalTrials.gov, the largest trial registry at the time, contained 13 153 trials; this number climbed to 22 714 one month after the policy came into effect.3 In April 2007, the registry contained over 40 000 trials, with more than 200 new trial registrations occurring weekly (D Zarin, personal communication). The four other registries that meet the ICMJE criteria have also grown as scores of journals have adopted the ICMJE clinical trials registration policy. In response to burgeoning registration, …

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