34 Definitions of Clinical Trials

PDAD&C #34, 2005-06

MEMORANDUM

To: Principals, Deans, Academic Directors and Chairs
From: John R.G. Challis, Vice-President, Research and Associate Provost
Date: October 31, 2005
Re: Definitions of Clinical Trials


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As communicated in my October 3rd memo, all clinical trials, as defined by the International Committee of Medical Journal Editors (ICMJE), are now required to be registered after REB approval, but prior to
commencement of the research activity. All ongoing trials should be registered immediately. ICMJE’s definition of clinical trial is as follows:

Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. By
“medical intervention” we mean any intervention used to modify a health outcome. This definition includes drugs, surgical procedures, devices, behavioural treatments, process-of-care changes, and the like… A trial must have at least one prospectively assigned concurrent control or comparison group in order to trigger the requirement for registration.

This registration does not replace the requirement of Health Canada to register clinical trials defined under Food and Drug Regulations, Division 5 – Drugs for Clinical Trials Involving Human Subjects and Natural Health Products Regulations:

Clinical trial means an investigation in respect of a drug or natural health product (NHP) for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug/NHP, identify any adverse event in respect of the drug/NHP, study the absorption, distribution, metabolism and excretion of the drug/NHP, or ascertain the safety or efficacy of the drug/NHP.

It is important to note that because these definitions differ greatly, many studies will fit into one of these two categories, triggering registration through Health Canada or ICMJE. A significant subset will
require dual registration. Please see http://www.hc-sc.gc.ca/dhp-mps/prodpharma/index_e.html or http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/prodnatur/propose2_regula-regle_doc6_e.html for information on registration of clinical trials with Health Canada.

For ICMJE-required registration, please see either  www.ClinicalTrials.gov or www.controlled-trials.com .

For more information, please contact Rachel Zand, Director, Ethics Review Office at Rachel.zand@utoronto.ca or 946-3389.