Questionnaire survey on medication compliance in clinical trials under new-GCP

To attain good medication compliance is the major premise in well-controlled clinical trials. We conducted a questionnaire survey on 40 clinical investigators, 25 sponsors and 20 trial subjects during Oct.-Dec. 1998 to investigate the correlation among actual circumstances of medication compliance in trial subjects and the evaluation of medication compliance by clinical investigators and sponsors, and to determine effective measures to improve medication compliance. Whereas almost all clinical investigators and sponsors evaluated or expected over 70% of medication compliance, the trial subjects answered over 90%. The clinical investigators (95%) and the sponsors (96%) thought in actuality that the primary means to maintain good compliance was for the clinical investigator to individually interview the trial subjects. The sponsors proposed possible adoption of clinical research coordinator's (CRC) support, a specific dispenser device or container, the use of medication diary, etc. However, only a few beneficial medication devices and medication diaries have been provided by the sponsors to date. This survey suggests that the medicine dispenser device and the interview by CRC are very effective to attain good medication compliance.