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Clinical Trial Registration

Information and FAQ's regarding the registration of clinical trials including which trials require registration, how to register a trial, acceptable registries and a list of member journals.

In 2005, the International Committee of Medical Journal Editors (ICMJE) announced that in order for clinical trial results to be considered for publication in journals that adhere to ICMJE standards, all clinical trials that started recruiting patients or volunteers on or after July 1, 2005 must be registered with a public registry before the enrollment of the first subject. It was also announced that ongoing trials not registered at inception would be considered by the ICMJE for publication if they were registered before September 13, 2005. All trials with recruitment completed before July 1, 2005 were not required to be registered.

The purpose of clinical trial registration is "to promote the public good by ensuring that everyone can find key information about every clinical trial whose principal aim is to shape medical decision-making" and to foster conditions in which decisions about care "rest on all of the evidence, not just the trials that authors decided to report and that journal editors decided to publish."

Included among the ICMJE are the following member journals:

  1. Canadian Medical Association Journal
  2. Journal of the American Medical Association
  3. New England Journal of Medicine
  4. The New Zealand Medical Journal
  5. The Lancet
  6. Annals of Internal Medicine
  7. Croatian Medical Journal
  8. Dutch Journal of Medicine
  9. Journal of the Danish Medical Association
  10. Annals of Internal Medicine
  11. The Medical Journal of Australia
  12. Norwegian Medical Journal
  13. Archives of Internal Medicine

What is the ICMJE definition of a clinical trial?

The most recent editorial on trials registration discusses the evolution of the ICMJE definition of clinical trials. In June 2007 the ICMJE adopted the WHO’s definition of clinical trial: "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." Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration. The ICMJE member journals will start to implement the expanded definition of clinically directive trials for all trials that begin enrollment on or after 1 July 2008. Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal. The ICMJE secretariat office is unable to review specific studies to determine whether registration is necessary. If researchers or others have questions about the need to register a specific study, they should err on the side of registration or consult the editorial office of the journal they wish to publish the study in.

Which trials registries are acceptable to the ICMJE?

Acceptable registries as of January 2006 include:

  1. www.actr.org.au (Australia)
  2. www.clinicaltrials.gov (USA)
  3. www.ISRCTN.org (UK)
  4. www.umin.ac.jp/ctr/index/htm (Japan)
  5. www.trialregister.nl (The Netherlands)

In addition to the above registries, in June 2007 the ICMJE began accepting registration in any of the primary registries that participate in the http://www.who.int/ictrp/network/primary/en/index.html.

How do I register a trial with ClinicalTrials.gov?

If you wish to register your trial through ClinicalTrials.gov, access the Protocol Registration System at http://prsinfo.clinicaltrials.gov/ and follow these steps:

  1. Apply for an Individual (User) Account, which is intended for PIs wanting to register one or more trials. Follow the web links to apply for an individual account. Complete the requested information on the screen titled "Individual Account Application" and submit the application.
  2. Within two business days, ClinicalTrials.gov will create your account and email you with instructions on how to login to the PRS, so that you can register your trials.
  3. If you have any questions about the registration process, please feel free to email register@clinicaltrials.gov.

Your User ID and password are valid for multiple registrations.

Are clinical trials registries in languages other than English acceptable to meet the ICMJE’s trials registration policy?

The ICMJE is cooperating with the WHO effort and will adopt WHO policy with respect to registry language. However, until the WHO has a mechanism in place to solve the problems of searching across registries in different languages, the ICMJE feels that the minimal data items need to be registered in English as well as in the native language of the registry.

Links to additional resources

  1. "Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication" (Updated October 2007)
    http://www.icmje.org/
  2. Brochure entitled "Registering clinical trials with clinicaltrials.gov"
    http://prsinfo.clinicaltrials.gov/registering.pdf
  3. "Is This Clinical Trial Fully Registered?: A Statement from the International Committee of Medical Journal Editors"
    http://www.icmje.org/news-and-editorials/update_2005.html