Reviewing and Constructing Clinical Trials Database for Psychotropic Drugs in Korea / 대한정신약물학회지

ABSTRACT

OBJECTIVE: Evidence-based medicine (EBM) became an important framework to help clinicians judge and decide on what is better or desirable practice under National Insurance Scheme. Clinical trials contribute to building the data for EBM. We tried to investigate the characteristics of clinical trials which had been published in Korean psychiatry journals and constructed them as database form. METHODS: We reviewed all original articles about clinical drug trials regarding human in twenty Korean psychiatric journals published from 1995 to 2010. Inclusion criteria were randomized clinical trials (RCT), controlled clinical trials (CCT), non-controlled clinical trials (NCCT), non-trial naturalistic trials (NTN) including pharmacological intervention. Case reports and case series were excluded. Initial review and classification has been done by EBM researcher and expert review was followed by insurance committee members of Korean College of Neuropsychopharmacology. RESULTS: Total number of clinical trials was 328 and all the articles were classified according to patients subtype and intervention. Among them, NCCT was 151 (46%), NTN was 78 (23.7%), RCT was 59 (17.9%), and CCT was 36 (10.9%). In this study, the articles in The Korean Journal of Psychopharmacology were 130 (39.63%) and the proportion of RCT was the most in Journal of the Korean Neuropsychiatric Association (19.84%). The schizophrenia came with 158 (47.02%), followed by major depressive disorder and other depressive disorder, bipolar disorder, dementia, panic disorder, schizoaffective disorder, and generalized anxiety disorder. The proportion of Institutional Review Board approved study and study with research grant has increased. CONCLUSION: In this study, we investigated the characteristics of clinical trials for psychotropic drugs and finished to construct clinical trial database for psychotropic drugs in Korea. We hope this database should be used for researchers who want to collect clinical evidence data and make clinical guidelines for Korean psychiatric patients. In future, supplementation and management of clinical trial database for psychotropic drugs and quality control of articles are needed.