The applicability of results of streamlined trials to clinical practice: The myocarditis treatment trial

Abstract

The application of the results of clinical trials to medical practice depends in part upon the understanding and acceptance of study results by the practising physician. Involving non-academic practitioners as investigators in streamlined trials is an effective means to increase enrollment and minimize cost. Streamlining data collection to accommodate the needs of the practitioner, however, decreases the amount of scientifically and clinically relevant data that are collected. More important, biased enrollment is more likely in this setting. Modifications in organization and design of the Myocarditis Treatment Trial form an example of streamlining an ongoing clinical trial to enhance enrollment.