Preclinical and Clinical Trial Requirements
Preclinical and clinical trial requirements for pharma in Canada – a comprehensive legal overview. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
There is no requirement to conduct local trials of a new drug to receive marketing approval. Rather, in order to obtain marketing approval, a company must submit an NDS application containing information and data about the drug’s safety, effectiveness, and quality to Health Canada. See Regulatory, Pricing and Reimbursement Overview , Question 3.
2. How are clinical trials funded?
Canadian clinical trials are funded through a variety of public and private institutions. The federal Government of Canada funds research through the Canadian Institute of Health Research and the Natural Science and Engineering Research Council of Canada. Charitable organizations as well as the private sector also fund clinical research.
3. What are the requirements for pre-clinical and clinical trial protocols? Who must approve the protocols?
As a first step in drug development, pre-clinical studies are carried out to evaluate the safety of a drug and its potential use. These studies are carried out in vitro and in vivo to assess the performance of the drug, including assessment of the existence and extent of toxic effects. The pre-clinical studies provide important information on the potential use of the drug prior to testing on humans in clinical trials. If the pre-clinical studies are promising, the sponsor may apply to Health Canada for authorization to conduct a clinical trial involving human subjects in Canada.
Sponsors wishing to conduct a clinical trial must submit a Clinical Trial Application (“CTA”) to the Minister (other than clinical trials in Phase IV, which are performed after the drug is approved and on the market). The CTA must include copies of the clinical trial’s protocol and a statement of the risk and benefits to the health of participating trial subjects as set out in the informed consent form. CTAs must also contain an attestation signed by a senior medical or scientific officer in Canada and the senior executive officer containing information dealing with the drug, its destination, or the clinical trial.
Clinical trial sponsors may also submit an application to request a pre-CTA consultation meeting with Health Canada as an opportunity for the sponsor to present relevant data, discuss concerns, and receive guidance on the acceptability of the proposed trial. In addition, the clinical trial’s proposed protocol and informed consent form must be reviewed and approved by a Research Ethics Board (“REB”).
4. What are the requirements for consent by participants in clinical trials?
Consent must be free and informed. Those seeking consent must avoid undue influence through the exploitation of positions of authority and trust, as well as coercion such as threats of harm or punishment for failure to participate. Any incentives used must not be so excessive so as to promote the ignoring of risk.
Consent forms must include an outline of the risks and anticipated benefits to the individual’s health arising from participation in the clinical trial and all other aspects of the clinical trial that are necessary for that person to make an informed decision to participate in the clinical trial.
Participants must be able to withdraw their consent at any time.
5. May participants in clinical trials be compensated?
According to Health Canada, participants in clinical trials may be compensated for any inconvenience suffered (e.g. missed work), and as a paid incentive to participate in the trial. However, compensation may be deemed inappropriate if it is so large that it promotes reckless behaviours.
Provincial governments limit the types of financial compensation that may be offered to clinical trial participants. For instance, in Québec, it is not permitted to offer financial rewards other than the payment of an indemnity as compensation for the loss and inconvenience suffered as a result of research that could interfere with the bodily integrity of an individual. In contrast, in Alberta and Newfoundland and Labrador, researchers are allowed to provide financial incentives to research participants subject to the limitations of Health Canada outlined above. Such compensation must be justified in the REB submission.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
Participants in clinical trials are protected and indemnified against any harm that arises as a result of participation in the clinical trial through terms contained within consent forms, which outline the means of compensation for injury resulting from the clinical trial.
Clinical researchers who fail in their duty of care toward patients may also be held liable through the tort of negligence for medical malpractice and may also be held liable if harm occurs in a context where they have failed to obtain informed consent from their participants.