The NIDCD's clinical trials cooperative groups: a brief overview

The National Institute on Deafness and Other Communication Disorders (NIDCD) embarked on the establishment of two clinical trials cooperative groups in October 1996 in response to a scientific research need. It intended that the clinical trials cooperative groups (CTCGs) design and implement clinical trial protocols capable of addressing the efficacy of therapeutic interventions for diseases and disorders of human communication. Most commonly, owing to the substantial number of patients required, the trials are expected to involve multiple study sites, with each study site adhering to a uniform study protocol, standardized treatment regimens, and prescribed data collection procedures. A complex administrative structure is required to coordinate the activities of the CTCGs and to assure compliance with a myriad of government regulations. Similarly, participating study sites must meet stringent requirements including leadership by an individual experienced in clinical trials. There is a relative dearth of experienced clinical trialists dedicated to research in human communication. This article details the complexities involved in the conduct of multicenter clinical trials and the NIDCD's efforts to promote clinical trials activities and to develop clinical trials training opportunities.