抄録
Our hospital established a Center for Clinical Research of New Drugs and Therapeutics in April 1999. The Center consists of 6 departments : i.e. departments which help to coordinate clinical research, which help to manage the investigated drugs, preview clinical research study protocols, coordinate clinical research, educate research staff and support clinical research at other medical institutions. Pharmacists are involved in all 6 departments of the Center and have been playing various roles. Under this situation, the Institutional Review Board (IRB) started to review investigator-initiated clinical research on drugs, regarding the study protocol, written information (IC) for trial subjects and other information about the drugs beginning in January 2000. All research was performed according to the new Good Clinical Practice, but studies were initiated without providing sufficient compensation in cases of severe adverse drug reactions. The IRB reviewed thirty-four clinical research protocols from January 2000 to December 2001 and an average of 1.5 cases were reviewed by the IRB per meeting. The average reviewing time was 28 minutes (max. 68 minutes). Sixteen, eight, eight and two protocols of clinical research involved Phase III, I/II and II trials and medical instruments, respectively. Considerable clinical research has been performed by such departments as Internal Medicine I, II and Urology, in particular.
We recognized that considerable clinical research has been performed with unapproved drugs at our hospital. After the IRB review, pharmacists played various important roles, e.g. dispensing test drugs, preparing some manufactured drugs and confirming the written informed consent. However, up to now the clinical research coordinator (CRC) has not sufficiently supported these studies. The CRC should thus support this research by improving the quality of these studies and the safety performance for patients.
