Cover: Initiating Clinical Trials

Initiating Clinical Trials

A Case Study of Intermittent Positive Pressure Breathing

by Elizabeth A. McGlynn, James P. Kahan


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This Note describes the events surrounding the decision by the National Heart and Lung Institute (NHLI) to issue a request for proposal (RFP) to conduct a multicenter randomized clinical trial comparing the efficacy of intermittent positive pressure breathing (IPPB) with compressor nebulizer therapy in treating patients with chronic obstructive pulmonary disease (COPD). The Note describes (1) the disease process associated with COPD and the history of IPPB treatment for this disease; (2) the decisionmaking process that led to NHLI's decision to issue an RFP for the study of IPPB therapy; (3) the motivations of three of the investigators responding to the RFP; and (4) the case study as a model for future decisionmaking.

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