Are Investigational Drugs Getting you Down? One Hospital's Solution to the Increasing Number of Clinical Research Studies

Abstract

This article describes the process and results of employing an Investigational Drug Service Pharmacist (IDSP) to coordinate pharmacy support for clinical drug studies. In 1998, a Clinical Research Center (CRC) was established to coordinate all research at a 407-bed Baltimore teaching hospital, resulting in an increase in studies requiring pharmacy support. By the end of 1998, there was a backlog of nine studies awaiting review for feasibility and impact on pharmacy resources. A lack of communication between departments further impeded the process. In March 1999, a part-time pharmacist was hired to coordinate all drug studies; the pharmacist's salary was paid by the CRC. Primary responsibilities of the position were protocol review, staff education, and drug accountability. Dispensing was still handled by staff pharmacists. After three years, results were as follows: 72 studies were reviewed, 41 were opened for enrollment, 8 were in preparation, 16 were completed. Two studies alone have saved the pharmacy department over $80,000 in drug acquisition costs. The efforts of the IDSP have helped the CRC to more than double its growth, with gross income from studies of $533,712 in 2001 compared with only $237,663 in 1998. The IDSP has improved communication between the CRC and pharmacy and expedited study initiation. It has also made the CRC more attractive to prospective sponsors, since one pharmacist works directly with study coordinators. With more physicians interested in carrying out research and hospital budgets becoming tighter, the part-time IDSP position represents an important means of supporting these endeavors without increasing fiscal burdens.