Why register?

The International Committee of Medical Journal Editors (ICMJE) has announced that in order for clinical trial results to be considered for publication in all journals that adhere to the ICMJE standards, any clinical trial that starts recruiting patients or volunteers on or after July 1, 2005 MUST be registered with a public registry before the enrolment of the first subject. In addition, the TCPS2 Article 11.3 states that all clinical trials shall be registered before recruitment of the first trial participant in a publicly accessible registry that is acceptable to the World Health Organization (WHO) or the ICMJE.  This would apply to any CIHR-funded trials as well.

Details can be found here: http://www.icmje.org

 

  • What is a “clinical trial”?

    The current ICMJE definition (as of July 2008) is: “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects of health outcomes”. This includes any intervention used to modify a biomedical or health-related outcome (ie. drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes are things like biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies do not require registration.

  • Why is there a need to register?

    The ICMJE has indicated that clinical trial registration is important to prevent selective publication and selective reporting of research outcomes, to prevent unnecessary duplication of studies and research effort in general, to provide the public and patients know what trials are planned or currently open in case they want to enrol, and to also help give research ethics boards a view of the similar work out there.

  • Who registers the trial?

    Before enrolling any subjects, the PI should ensure that the trial has been registered. If the trial is investigator-initiated, the lead PI should register the trial. If the trial is sponsored by the NIH, and funded by an NIH Institute, that Institute will register the trial. Finally, if the trial is multi-site, the registration should be coordinated among the sites so that one sponsor is responsible for the registration. If the trial is industry sponsored, the industry sponsor should register the trial.

  • Where should I register my trial?

    According to the ICMJE, an acceptable registry must be accessible to the public at no charge, open to all prospective registrants (ie. not limited by geographic location, academic affiliation, etc), managed by a not-for-profit organization, have a mechanism to ensure validity of registration data, be electronically searchable, and include required data elements. To that extent, the ICMJE has reviewed the following registries and determined that they meet the above criteria: - http://www.anzctr.org.au (Australia) - www.clinicaltrials.gov (U.S.) - www.ISRCTN.org (U.K.) - http://www.umin.ac.jp/ctr/index.htm (Japan) - http://www.trialregister.nl/trialreg/index.asp (Netherlands) In addition, it accepts registration from the primary registries in the WHO Registry Network, which can be found here: http://www.who.int/ictrp/network/primary/en/. 

  • Do I have to report my clinical trial results on a registry?

    As of January 18, 2016, ICMJE only requires the registration of a clinical trial. Any studies that are subject to FDAAA (except phase 1) or the NIH Policy must report their results as well. https://deainfo.nci.nih.gov/advisory/ctac/1116/Att%2016.pdf