Questionnaire to the Investigators and Monitors of the Sponsors of the Clinical Trials Enforcement System for Clinical Trials Promotion: Discussion on Results of the Study

The number of clinical trials in Japan is decreasing following the new GCP enforcement. For the promotion of clinical trials, establishment of a clinical trial enforcement system which meets the investigators and the sponsors' expectations, is necessary. We questioned the investigators and sponsors about problems in the clinical trial enforcement system and the function of the clinical research coordinator (CRC) in Nagasaki University Hospital. The results suggested that investigators and sponsors need assistance from CRC for a large portion of their clinical trial practices. It was noteworthy that when a sponsor applies for clinical trials to hospitals or clinics, the most important problem is the complexity of the document related to the clinical trial. The investigators and the sponsors need to be aware that a low number of participants prevents the progress of clinical trials. In addition, it was suggested that an economic incentive given to the investigators for clinical trial promotion is desirable