The quality of conduct in Japanese clinical trials: deficiencies found in GCP inspections

Abstract

The quality of commercially sponsored clinical studies in Japan was examined with reference to deficiencies in the audit reports issued by the Organization for Pharmaceutical Safety and Research (OPSR). The OPSR is responsible for domestic good clinical practice auditing in Japan. Routine audits from 1997 to 2000 for 331 hospitals revealed various types of deficiencies such as errors in case report form (CRF) entries, institutional review board problems, and protocol deviations. The high prevalence of CRF-related deficiencies seemed to stem from peculiarities of the Japanese study environment such as the historical lack of on-site monitoring by the sponsor and the absence of research nurses. Characteristics in usual medical practices such as multiple drug use and loose informed consent also seemed to be associated with prevalence of similar deficiencies in clinical trials.