18. Post Registration Clinical Studies

The main purpose of a study will be to answer scientific question(s) which requires obtaining and evaluating data on safety and/or efficacy, effectiveness, cost effectiveness, quality of life, functional or other socio-economic factors that have to do with clinical use of the Prescription Medicine.

Studies must provide a scientific framework for investigation of the medicine in broader or special populations.

All studies must have a clearly defined objective which is amenable to scientific review and testing. Duplication or redundancies in studies must be medically and ethically justifiable.

The Member must ensure that studies are designed/approved and administered by qualified people in the medical/scientific department, using the same kinds of methodology (i.e. the planning, protocol development, monitoring and data interpretation) that apply to pre-marketing trials.

As the post-registration clinical study may include the dissemination of devices or diagnostic equipment (including, without limitation, blood pressure monitors and glucose meters) for use by the Health Care Professional or the subject as part of the clinical study, it is the Member’s responsibility to ensure that this material is appropriately distributed prior to the study and collected subsequent to the study, by the medical/scientific department. Members must maintain a record of dissemination to Health Care Professionals and use reasonable methods to retrieve this equipment from the Health Care Professionals upon the completion of the study.

Sales representatives and their direct supervisors’ role in the process must be limited to the distribution and collection of materials pertinent to the study, on behalf of the medical/scientific department.

Studies must be carried out in accordance with the Food and Drugs Act and Food and Drug Regulations, other applicable federal and provincial legislation, guidelines issued by Health Canada, and applicable privacy legislation. Such studies are to be conducted in accordance with the Food and Drugs Act and Food and Drug Regulations (including the principles of Good Clinical Practice described therein), the International Conference on Harmonization-Good Clinical Practice: Consolidated Guideline, and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.

Studies must be carried out using a written protocol that will provide answers to specific research questions. All studies must be consistent with good clinical practice. The protocol must be designed to ensure scientifically meaningful results, and should contain details about the following:

a. Study background/scientific rationale;
b. Study objective;
c. Study design;
d. Study population;
e. Adverse event reporting;
f. Sample size based on primary and/or secondary endpoint;
g. Description of measures to minimize bias (such as randomization or blinding);
h. Study methodology;
i. Duration of subject participation and study duration;
j. Data collection method;
k. Predefined statistical plan consistent with the objectives; and
l. Appropriate external reporting of results (e.g. in a peer reviewed journal or on a clinical trial website).

Researchers must collect data according to the protocol and keep the research results on file with the Member as required by applicable law and/or regulations.

After the data are collected but before the study is published, the researchers and medical/scientific department of the Member must jointly review the scientific evaluations of data.

Researchers’ compensation must reflect costs incurred in conducting the study, such as professional fees, salaries of study staff , and laboratory tests. Compensation may be in the form of a monetary grant, travel to attend scientific and medical meetings, and/or equipment, provided the latter is needed for and relevant to the study. Agreements between Members and Health Care Professionals for the study must be clearly defined, constitute part of the investigator and Member files, and any remuneration must be reasonable and reflect the fair market value of the services provided.

Payment to researchers must not be based on continuing administration of the Prescription Medicine under study to patients after the researcher has completed the study protocol.

Material provided to the Health Care Professionals to outline the protocol, procedure, patient treatment and collection of data in a study should be clear and concise. The material should not incorporate the branding of the product, i.e. colours, images or other marketing/mnemonic devices that are an extension of the advertising material.

Any correspondence or presentations to investigative staff during the course of a study should have no product or branding claims.

If product is supplied to the Health Care Professionals to use in the study, it should be labelled “For clinical trial use only”.

Investigator meetings in the context of studies can be organized for any of the following reasons:

a. review the protocol;
b. review working processes;
c. review of SAE, ICH and GCP guidelines;
d. training of investigational site personnel in study conduct;
e. review study progress and issues; or
f. review the results of the study in which they participated.

The attendees at such meetings should be limited to Member personnel from the medical/scientific departments and if warranted, other Member employees who have an essential role in the functioning of the study from the design, conduct or management perspective.

When these studies are national only in scope the meeting must be held in Canada.

Section 6 should be referred to with regards to social interaction incidental to such meetings.

All standard communications with investigators in preparation for the meeting should be worded accordingly.

A post registration clinical study (for the purposes of this Section 18, “study” or “studies”) is any study within the approved indications that is conducted after Health Canada’s Notice of Compliance has been issued for a prescription medicine.

A study with the underlying purpose to familiarize Health Care Professionals and/or patients with the use of a prescription medicine or encourage its prescription, often referred to as “seeding” or “experience” trials, is not an acceptable post registration clinical study.