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We felt that pharmacists should participate more actively in the evaluation of efficacy and safety in clinical trials. To improve the capability of pharmacists in this respect, we evaluated the support we gave to the investigators of the Japan EPA Lipid Intervention Study (JELIS), a long-term, large-scale clinical trial conducted at the Department of Pharmacy of our hospital. To identify the problems in our support, we investigated the number of days required to complete the Case Report Form (CRF) and the reliability of the data collected, by considering the adequacy of the items observed and the clinical inspection terms. Our findings indicated that it was feasible for pharmacists to handle the coordination of JELIS in addition to their everyday workload and we also noted an improvement in the clinical inspection rate, from 76.6% to 100% for JELIS I and from 97.5% to 100% for JELIS II. Moreover, we found the number of days required to complete the CRF was reduced from 109.8 days to 20.3 days for JELIS I and from 79.5 days to 21.0 days for JELIS II. These results show that the pharmacists in our hospital helped to maintain the reliability of clinical data.

Importance of Efficient Coordination of Long-Term, Large-Scale Clinical Trials and Problems Arising-Role of Hospital Pharmacists in this Activity-