The Characteristic Factors of Clinical Studies Influencing on the Research Management of the Institutional Review Boards

Abstract

Background: The number of clinical trials which have been performed within Korea is increasing accompanied by the enlargement of the various responsibilities of each Institutional Review Board (IRB) in the way of providing adequate and on-time managerial involvements on the studies. Many confounding factors of each study can influence on the results with which delaying the final reports, or extending the review times associated with research-periods, or adjusting the alterations. Even though these factors were closely related to the results being managed by the IRBs, no in-depth research have been implemented to elucidate the correlations between these factors and the results necessitates IRBs’ managements. Methods: Study subjects were selected and analyzed retrospectively in a University hospital’s database. About 190 study projects which had been completed during 2005 to 2007 were retrieved and the characterized factors were classified into seven categories. Each category was analyzed and tested statistically by SAS program. Results: It is revealed that a large portion of the factors was subjected to the study profiles. The review-time showed extended tendency in the subjects which used medications (P=0.0174) required approval (P=0.0009) in phases ⅠⅡⅢ (P<0.0001) initiated by sponsors (P<0.0001) and with duration of 1 to 2 years (P=0.0442). Prior to submitting IRB, correction-times were multiplied specifically on the study subjects that used medications (P<0.0001) required approvals (P<0.0001), underwent phase ⅠⅡⅢ (P<0.0001) reviewed twice (P=0.0074) initiated by sponsors (P<0.0001) exceeded 2 years of period (P<0.0001) and required modifications before the submission (P=0.0001). Conclusion: Theclinical study projects characterize by ‘medication-used’, ‘sponsor-initiated’, ‘approval-required’, ‘duration period of 1 to 2 years’, and ‘under phase ⅠⅡ Ⅲ’ required thorough concerns and investigations from the beginning stage to reduce the time of review by the IRBs. Studies lasted more than 2 years entailed preparation of the sudden alterations to prevent the study duration. A new further study is necessary to analyze the frequency and the causes of the alterations in the study proposals.