Ad-hoc COVID-19 Clinical Pharmacology Task Group

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Background

The Clinical Pharmacology Task Group (CPTG) is an ad-hoc advisory committee comprised of experts in the fields of infectious disease, microbiology, clinical pharmacology and pharmaceutical sciences. The COVID-19 pandemic presents an unprecedented need for the rapid synthesis of current evidence to provide guidance to inform decision makers and healthcare professionals on the use of pharmaceuticals for the treatment or chemoprophylaxis of COVID-19. The CPTG was convened by the Public Health Agency of Canada (PHAC) in response to this need.

Following a national call for nominations, members were selected with consideration to ensure a diverse representation from across Canada.

Members participate on a volunteer basis and are obligated to declare any potential competing interests. Conflicts are assessed by government officials and members are excluded from discussion if they have real or perceived conflict(s) of interest.

Process

Given the fast pace of accumulating clinical evidence on pharmaceuticals for the treatment or chemoprophylaxis of COVID-19, the CPTG has adapted an evergreen method to develop evidence-based recommendations.

The CPTG Secretariat compiles daily evidence summaries on the clinical evidence of investigational COVID-19 pharmaceuticals (e.g. peer-reviewed journals, preprints, and press releases). All randomized controlled trials or clinical trials comprising of >500 participants testing a pharmaceutical for the treatment or chemoprophylaxis of COVID-19 are summarized, while other clinical studies are compiled as a list of citations and abstracts. CPTG members receive these clinical evidence compilations in daily emails.

The CPTG co-chairs determine when there is sufficient evidence on an investigational therapeutic (i.e. randomized controlled trials adequately powered to provide evidence of efficacy and safety) to warrant a risk-benefit analysis on its clinical use for the treatment or chemoprophylaxis of COVID-19. The CPTG Secretariat compiles clinical evidence of the pharmaceutical’s efficacy and safety, as well as other aspects of the intervention, including authorization status in Canada and worldwide, known interactions with other drugs, and its pharmacokinetic and pharmacodynamic profile. The CPTG Secretariat presents the summary of this evidence to CPTG members at an official CPTG meeting.

Following a thorough review of the evidence and discussion among the CPTG members, the CPTG co-chairs propose a written recommendation statement, which is then circulated to CPTG members for input and ratification. The CPTG statement summarizes the available clinical evidence and presents a risk-benefit analysis of the pharmaceutical’s use. This includes a description of relevant considerations, rationale for specific decisions, and knowledge gaps. Each statement ultimately provides a recommendation on a COVID-19 pharmaceutical to decision makers within government, and for the use of Canadian clinicians. As new evidence emerges, CPTG statements are reviewed by the task group and updated as required.

Terms of reference

The terms of reference outline the mandate, membership, and roles and responsibilities of the ad-hoc COVID-19 Clinical Pharmacology Task Group.

Statements

The ad-hoc COVID-19 Clinical Pharmacology Task Group has released the following statements. They may be updated as new evidence emerges.

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