Clinical Trials

Clinical drug trials (Phase I, II, and III) must be approved by Health Canada prior to their commencement. A copy of the Health Canada “No Objection Letter” (NOL) must be forwarded to the REB office, since without it the file will be incomplete. The REB will start the ethical evaluation of the project but without the NOL a final approval of the protocol will not be produced until the file is complete.

According to the Tri-Council Policy Statement (TCPS 2) a clinical trial is “any investigation involving participants that evaluates the effects of one or more health-related interventions on health outcomes. Interventions include, but are not restricted to, drugs, radiopharmaceuticals, cells and other biological products, surgical procedures, radiologic procedures, devices, genetic therapies, natural health products, process-of-care changes, preventive care, manual therapies and psychotherapies. Clinical trials may also include questions that are not directly related to therapeutic goals – for example, drug metabolism – in addition to those that directly evaluate the treatment of participants.” (Chap. 11, p.163)

Please refer to Health Canada website.

Clinical Trial registration is mandatory

According to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TPCS 2, Article 11.10), clinical trials shall be registered before recruitment of the first trial participant in a publicly accessible registry.

https://www.clinicaltrials.gov/

When should I register my clinical trial study?

«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 International Committee of Medical Journal Editors (ICMJE).” (TCPS2,Article 11.10)

Who is responsible for registering the study?

  • In the case of studies financed by the industry the sponsor of the clinical trial is responsible for registering the clinical trial and setting up the initial protocol record.
  • In the case of studies financed by Federal or Provincial grant as well as non-profit organization or other internal sources the Primary Investigator (PI) named on the research ethics application is the person responsible for registering the clinical trial and setting up the initial protocol record. In both cases the designated person has to update the records on clinicaltrials.gov every 6 months as required and ensuring that all required information has been completed and submitted.

Please consult the  information page of ClinicalTrials.gov.
  • Which considerations will be taken into account for the ethical review?
 Studies can be registered by selecting ‘pending’‘ ethics approval. After it has been approved by the REB, the registry must be updated.

The team must provide the REB with the study registration number (NCT number).

NOTE : Clinical Trials should be registered only once, hence for multicentre project the designated person will register the trial

 
  • Is it required to update the project after it has been registered?
 “Following registration of their study in accordance with Article 11.10, researchers are responsible for ensuring that the registry is updated in a timely manner with:

  • new information (Article 11.8);
  • safety and, where feasible, efficacy reports (Article 11.6);
  • reasons for stopping a trial early; and
  • the location of findings

The Application for REB Review now includes a section asking whether a clinical trial has been or will be registered. If there are no plans to register the trial, the PI is asked to justify why registration is not planned.