Initiating a clinical trials cooperative group in an increasingly managed care environment: successes and problems in establishing collaboration.

The Communication Sciences and Disorders Clinical Trials Research Group (CSDRG) was organized in 1995 and funded in 1997 by the National Institute on Deafness and Other Communication Disorders (NIDCD) as a cooperative clinical trials group. It designs and conducts multi-institutional randomized clinical trials focusing on treatments delivered by speech-language pathologists (SLPs) and audiologists for disorders of speech, language, hearing, balance, and voice/swallowing. Data are presented on a comparison of the number of site participants from the group's onset in 1995 through 31 December 1997. Successes and problems experienced by CSDRG are defined with regard to organizing the group, and designing and conducting clinical trials in a managed care environment with nonprimary care professionals. Different barriers to participation are identified at various levels of care/types of institutions and with various types of patient populations, for example, children receiving their health care through the schools versus elderly, demented individuals in nursing care facilities.