Support Systems for Clinical Trials in Kyoto University Hospital.

Accession number;01A0256088
Title;Support Systems for Clinical Trials in Kyoto University Hospital.
Author; ISHIZUKA RYOKO (Kyoto Univ., Hosp.) FUKATSU SACHIO (Kyoto Univ., Hosp.) MARUYAMA SHIHOKO (Kyoto Univ., Hosp.) NAKAGIRI MAKIKO (Kyoto Univ., Hosp.) OZAKI JUNKO (Kyoto Univ., Hosp.) ISHIZU MASAHIRO (Kyoto Univ., Hosp.) INUI KEN'ICHI (Kyoto Univ., Hosp.) SASAYAMA SHIGETAKA (Kyoto Univ., Hosp.)
Journal Title;Japanese Journal of Hospital Pharmacy
Journal Code:Y0888A
ISSN:0389-9098
VOL.27;NO.1;PAGE.57-62(2001)
Figure&Table&Reference;FIG.6, TBL.2, REF.11
Pub. Country;Japan
Language;Japanese
Abstract;Pharmacists play various roles other than merely dispensing test drugs at our hospital for the appropriate performance of clinical trials in accordance with the new GCP guidelines: e.g. do a preliminary review, function as the office of the Institutional Review Board, prepare for monitoring and auditing by the sponsor, conduct the follow-up of patients involved in clinical trials, check for inclusion/exclusion criteria on enrollment. Pharmacists thus contributed to the successful completion of 93 cases from July 1997 to January 2000. The items of management were as follows: 1) the prevention of protocol deviations (46 cases), 2) the follow-up of subjects (22 cases), 3) managing the financial affairs and payments to subjects (14 cases), 4) corresponding to adverse events in subjects ( 9 cases) etc. Especially, 18 cases of protocol deviation occurred at the time of enrollment, and most of them were a contravention of exclusion criteria such as medication using prohibited combinations. Supports for the appropriate enrollment of patients into clinical trials was thus suggested to be important to ensure the safety of patients. Based on the above information, pharmacists should therefore play an active roll in clinical drug trials since their professional knowledge and skill are often of vital importance. (author abst.)
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