초록
Background: Due to the strong relationship between successful clinical trial result and subject's high compliance to protocol, this research aimed to provide the basic information of the key factors affecting subject's compliances to improve the quality of the clinical trial. Method: The cross sectional study was retrospectively investigated with the result of the phase III clinical trial which had been conducted with co-participation of investigators belonged to two different medical specialties involving 15 university affiliated hospitals. The factors were classified into subject factor, institution factor, principal investigator factor, study staff factor and clinical research associate (CRA) factor. The collected data was tested at significance level of 5% using SAS program and analyzed by chi-square test, multiple logistic regression analysis and stepwise multiple regression analysis. Result: Among subject's compliances, the factors affecting the visit completion and medication compliance were come out differently. In terms of the visit completion, as a result of stepwise multiple regression analysis, the rate of visit completion was 4.9 times higher in the group of subjects taking corticosteroids than others, which is significant. In addition, the rate of visit completion was 10 times and 6.5 times respectively higher with principal investigators and clinical research coordinators belonging to the department in charge of the subject enrollment with subject's underlying disease treatment than the department in charge of the tests during the clinical trial, which is significant. Particularly, in terms of medication compliance 80% of investigational product medication compliance was shown in the group of no CRA change which is 4.0007 times significantly higher than others. Conclusion: Among subject's compliances, the significantly high influential factor for the visit completion was the subjects taking corticosteroids which were one of the risk factor for peptic ulcer and the specialty factor in charge of the continuous treatment for subjects and its principal investigator. Also, the factor which had significantly highly affected subject's medication compliance was CRA factor. Since subject's compliances were limited with the visit completion and medication compliance in this study, further investigations about subject's compliance are required. Also, it will be necessary to investigate CRA's indirect influence to subject's medication compliance in detail in the future.
