Methodological Review on Cardiovascular Disease Clinical Trials in Korea

ABSTRACT

BACKGROUND: Cardiovascular disease is the major cause of death in industrialized countries including Korea. METHODS: The methodology of cardiovascular disease clinical trials, published in 'The Korean Circulation Journal(KCJ)' and in 'The Korean Journal of Internal Medicine (KJIM)' from 1971 to 1993 were reviewed. For the study period, a total of 169 research papers in this field, includion 155 papers in the KCJ and 14 in the KJIM, were reviewed. To review the methodology behind the cardiovascular disease clinical trials, presence of a control group, set up a primary end point, determined sample size and the statistical method to be used, report on the side effects, and consent of patients were checked. In cases involving clinical trials using control groups, rendomization and blinding were also analysed. RESULTS: Among clinical trials reviewed only 6 (4.0%) of the 169 papers were used a control group, and 46.7% were set up with a primary end point. There was no clinical trial which used statitical methods to estimate the sample size. Clinical trials which reported results with statistical methods were 107 to 169 papers;most of these used the student's paired t-test. The number reporting the side effects of intervention was 143(88.7%) and papers reporting with the consent of patients was 15(8.8%). CONCLUSION: Most of clinical trials reviewed did not use appropriate method for clinical trials. Methodologically well-designed clinical trials in cardiovascular disease should be performed to guarantee the validity of study result.