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Clinical Trials Registry

For more information see clinicaltrials.gov

FAQs: Registration of Ongoing Clinical Trials
The following are additional FAQs concerning the International Committee of Medical Journal Editors (ICMJE) policy on registration of Phase 3 and 4 clinical trials. See our article in the Sept/Oct issue of Pursuit for details on the process.

What journals do the ICMJE (International Committee of Medical Journal Editors) represent?
The ICMJE journals include: New England Journal of Medicine, Journal of the American Medical Association, Annals of Internal Medicine, The Lancet, The Medical Journal of Australia, The New Zealand Medical Journal, Norwegian Medical Journal, Canadian Medical Association Journal, Croatian Medical Journal, Dutch Journal of Medicine, Journal of the Danish Medical Association.

What is the definition of a clinical trial?
The ICMJE defines a clinical trial as “any research project that prospectively assigns human subjects to intervention and at least one concurrent control or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome."

What is the definition of a medical intervention?
The ICMJE defines medical intervention as any intervention used to modify a health outcome, including drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like.

What are the requirements for registration of a clinical trial?
In order for trial results to be considered for publication in an ICMJE journal, clinical trials that start recruiting on or after July1, 2005 must be entered in a public registry before the onset of subject enrollment.  The registry must be accessible to the public at no charge, be opened to all prospective registrants, be not-for profit, have a mechanism to ensure the validity of the registration data, be electronically searchable and contain the meaningful data that meets the minimal data set requirements.

What types of trials do not need to be registered?

  • Regardless of phase, trials using a historical control group, or no control or comparison group do not need to be registered.
  • Phase 1 trials with a primary goal to assess major unknown toxicity or determine pharmacokinetics do not need to be registered.

What are the Minimum Data Set Requirements established by the ICMJE?
The minimum data set requirements to be included in a trial registry are: The unique trial number; the date of registration; name of the organization(s) that provided funding for the study; the main entity responsible for performing the research; the secondary entities, if any, responsible for performing the research; the public contact person for the trial; the person to contact for scientific inquiries about the trial; the title which must include the name of the intervention, the condition being studied, and the outcome; whether the study at the time of registration received appropriate ethics committee approval; the medical condition being studied; a description of the study and comparison/control intervention(s); key patient characteristics that determine eligibility for participation in the study; estimated enrollment date of the first participant; the total number of subjects the investigators plan to enroll before closing the trial to new participants; the primary outcome that the study was designed to evaluate and any secondary outcomes specified in the protocol.

What databases do not meet the ICMJE standards?
Controlled-trials.com is a U.K. site developed and maintained by Current Controlled Trials Ltd, part of the Current Science Group of Biomedical publishing companies.  There are other international sites which may meet the ICMJE requirements.

  • Clinicalstudyresults.org is a database of trial results developed and maintained by PhRMA (Pharmaceutical Research and Manufactures of America).  This site does not meet the ICMJE standards and is not considered a registry of clinical trials.

Is this policy the same as the NIH Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research?
No, these are two separate and unrelated requirements.  The NIH Policy requests that beginning May 2, 2005 NIH-funded investigators submit to the National Library of Medicine’s PubMedCentral an electronic version of the author’s final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH.  See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html for details and requirements related to the NIH Public Access Policy.

Where can I read more about registration of trials?

  • International Committee of Medical Journal Editors at: http://www.icmje.org/clin_trialup.htm
  • DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292:1363-1364.
  • Center for Drug Evaluation and Research; US Food and Drug Administration. Guidance for industry information program on clinical trials for serious or life-threatening diseases and conditions. Available at: http://www.fda.gov/cder/guidance/4856fnl.htm. Accessibility verified May 18, 2005.
  • Rennie D. Trial registration: a great idea switches from ignored to irresistible. JAMA. 2004;292:1359-1362.
  • Dickersin K, Rennie D. Registering clinical trials. JAMA. 2003;290:516-523.
  • DeAngelis CD, Drazen JM, Frizelle FA, et al. Is this clinical trial fully registered? a statement from the International Committee of Medical Journal Editors. JAMA. 2005;293:2927-2929.