Initiating Clinical Trials: A Case Study of Intermittent Positive Pressure Breathing

摘要

The case study describes the National Heart, Lung and Blood Institute's (NHLBI) decision to issue a request for proposals for a randomized clinical trial (RCT) comparing the efficacy of intermittant positive pressure breathing (IPPB) with compressor nebulizer therapy in treating chronic obstructive pulmonary disease (COPD). Initiation of this RCT resulted from a conference sponsored by the National Institutes of Health (NIH) on the scientific basis of respiratory therapy for COPD, which concluded that IPPB had not been demonstrated to be effective, but its widespread use and expense relative to other therapies warranted a controlled clinical trial of long-term effects. The need for a multicenter trial, combined with a need to guarantee standardization and comparability across sites, led to the decision to proceed through funding by an NHLBI contract. The request for proposals resulted in the selection of five clinical centers and one data coordinating center.