CLINICAL RESEARCH IN THE PRACTICE SETTING

Abstract

The majority of past clinical trials have been performed in large academic centers. In the late 1980s, many clinicians desired the opportunity to develop many of the new compounds for a variety of disease states. In the early 1990s, practice-based research began to take hold as the premier location to conduct clinical research trials. The subspecialty of allergy and asthma was one of the first to embrace outpatient clinical research. The majority of patients with asthma and allergy were already managed in an outpatient setting, with most practices managing a significant number of patients. Large patient management enticed pharmaceutical sponsors with thoughts of rapid enrollment and quicker Institutional Review Board (IRB) approvals, therein expediting approval by the Food and Drug Administration (FDA). This outcome was not without its own problems in the early years, as many investigators had not considered the infrastructure necessary to conduct clinical trials in an outpatient practice. In this article, we give the reader a brief history of practice-based clinical research, along with a clear description of the requirements necessary to conduct a clinical research protocol in the private practice setting.