Is standardization of background drug therapy necessary in clinical trials in patients with heart failure?
Highlights the need and provides conceptual approaches for standardizing background pharmacological therapy in HFrEF clinical trials.
With the current landscape of approved therapies for heart failure (HF), there is a need to determine the role of a standard background therapy against which novel therapies are studied. The Heart Failure Collaboratory convened a multistakeholder group of clinical investigators, clinicians, patients, government representatives including U.S. Food and Drug Administration and National Institutes of Health participants, payers, and industry in March 2021 to discuss whether standardization of background drug therapy is necessary in clinical trials in patients with HF. The current paper summarizes the discussion and provides potential conceptual approaches, with a focus on therapies indicated for HF with reduced ejection fraction.
Fiuzat et al. (Mon,) studied this question.
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