Registration of clinical trials

Steve Simon


[StATS]: Registration of clinical trials (July 22, 2005)

International Committee of Medical Journal Editors (ICMJE) has called for a requirement for registration of clinical trials. All clinical trials that start recruiting on or after July 1, 2005 must be placed in a public registry before enrollment of the first patient. This includes

trials that test a clinical hypothesis about health outcomes

but not phase 1 trials that only assess toxicity and/or pharmacokinetics. There is a gray area.

Between these two extremes are some clinical trials whose prespecified goal is to investigate the biology of disease or to provide preliminary data that may lead to larger, clinically directive trials. We recognise that requiring public registration of trials whose prespecified goal is to investigate the biology of disease or to direct further research might slow the forces that drive innovation. Therefore, each journal editor will decide on a case-by-case basis about reviewing unregistered trials in this category. Authors whose trial is unregistered will have to convince the editor that they had a sound rationale when they decided not to register their trial. The ICMJE will maintain this policy for the next two years. We will then review our experience.

There are twenty elements that should be part of the registration.

  1. Unique trial number
  2. Trial registration date
  3. Secondary IDs (if any)
  4. Funding source(s)
  5. Primary sponsor
  6. Secondary sponsor(s)
  7. Responsible contact person (public inquiries)
  8. Research contact person (scientific inquiries)
  9. Title of the study (can be omitted if the researchers wish).
  10. Official scientific title of the study This title must include the name of the intervention, the condition being studied, and the outcome
  11. Research ethics review
  12. The medical condition being studied
  13. A description of the study and comparison/control intervention(s). The duration of the intervention(s) must be specified.
  14. Key inclusion and exclusion criteria
  15. Study type. This would include choices for randomised vs. non-randomised, type of masking (eg, double-blind, single-blind), type of controls (eg, placebo, active), and group assignment, (eg, parallel, crossover, factorial).
  16. Anticipated trial start date
  17. Target sample size
  18. Recruitment status Is this information available (yes/no) (If yes, link to information).
  19. Primary outcome. Description should include the time at which the outcome is measured.
  20. Key secondary outcomes.

The full text of the ICMJE statement can be found at the the Medical Journal of Australia (MJA 2005; 182 (12): 609-610) and the full free text is on the web at

It also appears in the New England Journal of Medicine ( N Engl J Med 2005 352: 2436-2438)

and CMAJ (CMAJ; June 21, 2005; 172 (13))

and JAMA, although JAMA does not allow you to view the full free text on the web.

You can also browse for pages similar to this one at Category: Publication bias.

You can find an earlier version of this page on my website.