The SUPPORT, BOOST II, and COT Trials: You Must Understand Usual Care To Safeguard Patients and Make Firm Conclusions
Charles Natanson, MD, Critical Care Medicine Department at the Clinical Center of the National Institutes of Health
Informed consent; Usual care; Standard of care; Human subjects protection; Clinical research; Outcomes research; OHRP; Institutional review board; Study design; Research ethics
In a clinical trial, understanding usual care (the control group) is critically important to the conclusions that can be drawn. Usual care can be protocolized, but not solely based on tradition, expert opinion, or guidelines. We must also provide actual studies or data to the institutional review board (IRB), ideally from hospitals enrolling patients, to support the design of the control group.
Characterizing usual care involves:
- A literature search (randomized controlled trials, observational studies, surveys of usual care)
- Chart review (range of therapy at enrolling hospitals, patient characteristics that determine treatment approach)
- Prospective studies (practice surveys, observational cohorts)
A potential solution is to clarify the Common Rule and distinguish between commonly used and novel or experimental therapies.
For studies reported as “usual care,” it is important to determine whether or not a commonly used therapy might be given in a novel or experimental manner.
IRBs need the full picture, and investigators conducting pragmatic trials must help the IRBs to understand usual care.
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