Clinical research: Trends affecting the pharmaceutical industry and the pharmacy profession

Trends in clinical research that affect the pharmaceutical industry and the pharmacy profession are described. Much of the time lag in bringing a drug to market has been linked to the ma nagement of clinical trials. The change in the investigative setting-from e xclusively academic health centers to nonacademic investigators, increasing ly in collaborative groups-has affected the conduct of clinical research. T he shift is related in part to administrative approval practices at academi c health centers. Contract research organizations (CROs) work as partners w ith pharmaceutical companies throughout the drug approval process (from sub mission of the investigational new drug application to submission of the ne w drug application). Trial management organizations organize, conduct, moni tor, and report the results of large-scale clinical trials. Site-management organizations work to bring investigators en masse to a sponsor at the tim e of site selection and to ensure the quality performance of trials. Academ ic health centers are changing their infrastructure to be user-friendly to research sponsors and their CRO representatives and to better compete for c linical research funds. Pharmacists play an active role in all sectors of c linical research. Academic health centers need to re-engineer themselves to provide high-qual ity clinical trials at a reasonable cost; pharmacists will continue to play an ever expanding role in drug development and clinical research.