Developing a framework for the ethical design and conduct of pragmatic randomized controlled trials 2017-09-14T14:19:41+00:00

Project Description

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Developing a framework for the ethical design and conduct of pragmatic randomized controlled trials

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To make informed decisions, patients, health providers and health system managers need reliable evidence of treatment safety, effectiveness and cost. Pragmatic randomized controlled trials (RCTs) are designed to provide such evidence by evaluating treatments in real-world conditions. But pragmatic RCTs raise difficult ethical issues that challenge researchers and research ethics committees. Our research team, comprising 25 philosophers, trialists and biostatisticians from five countries, will develop guidance for the ethical design and conduct of pragmatic RCTs.

PRINCIPAL INVESTIGATORS:

  • Monica Taljaard (Nominated Principal Investigator; Ottawa Hospital Research Institute)

  • Dean Fergusson (Ottawa Hospital Research Institute)

  • Terry Klassen (Manitoba CIHR SUPPORT Unit)

  • Charles Weijer (Rotman Institute of Philosophy, Western University)

PROJECT DATES:

2017 – 2021

PROJECT FUNDING:

Canadian Institutes of Health Research

Western University

PROJECT SUMMARY:

The randomized controlled trial (RCT) is a highly reliable method for evaluating treatment in health care. However, most RCTs are conducted under laboratory-like conditions, which limits their applicability to practice. There is therefore an urgent need for pragmatic RCTs, which are undertaken in real-world settings. Pragmatic RCTs provide patients, health providers and health system managers with reliable information on the safety, effectiveness and cost of treatments. Although ethical guidelines exist to protect participants in research, they were not written with pragmatic RCTs in mind. The lack of fit between current guidance and pragmatic RCTs leads to inadequate protections and unnecessary obstacles. In some instances, research participants are left unprotected in research; in other cases, socially important research is hindered.

Our research team, comprising 25 philosophers, trialists and biostatisticians from five countries, will develop guidance for the ethical design and conduct of pragmatic RCTs. Questions addressed include: When stepped wedge RCTs seek to study the roll-out of government policies, ought they be considered research or program evaluation? When pragmatic RCTs compare routinely available medical treatments, should the study interventions be classified as research or practice? Does clinical equipoise apply to pragmatic RCTs evaluating policy, knowledge translation or public health interventions? Must patients in pragmatic RCTs always be informed about trial participation and provide informed consent? When may a waiver of consent be used in pragmatic RCTs and what justifies such use? What is the role of gatekeepers in pragmatic RCTs? We will address these (and other) questions through a combination of ethical analysis and empirical study. This work will feed into a consensus process that will generate ethical guidance for researchers and research ethics committees globally.