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Traditional and Alternative Designs for Pulmonary Arterial Hypertension Trials

¹ University of Chicago Medical Center, Chicago, Illinois

Correspondence and requests for reprints should be addressed to Mardi Gomberg-Maitland, M.D., M.Sc., Director of Pulmonary Hypertension, University of Chicago Medical Center, Section of Cardiology, MC2016, 5841 S. Maryland Ave., Chicago, IL 60637. E-mail: mgomberg{at}medicine.bsd.uchicago.edu

ABSTRACT

This article elaborates on the phases of drug development and trial design for pulmonary arterial hypertension, emphasizing the need for learning trials to assess efficacy signals before confirming trials. In this new era in pulmonary arterial hypertension, we need to reconsider innovative trial designs to maximize efficiency and pursue agents with the greatest potential for cure.

Key Words: clinical trials • drug development • pulmonary hypertension

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