Independent Data Monitoring Committees: Review of Current Guidelines.
- Author:
Bo Ram LEE
1
;
Kyung Eun LEE
Author Information
1. College of Pharmacy, Chungbuk National University, Cheongju 28644, Republic of Korea. kaylee@cbnu.ac.kr
- Publication Type:Clinical Trial ; Original Article
- Keywords:
Independent data monitoring committee;
clinical trial;
operation guideline
- MeSH:
Clinical Trials Data Monitoring Committees*;
Europe;
Humans;
Korea
- From:Korean Journal of Clinical Pharmacy
2016;26(2):181-186
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
BACKGROUND: There has been on increasing emphasis on the importance of monitoring the safety of participants in a clinical trial to protect patients and maintain the integrity of the trial. The independent data monitoring committee (IDMC) has become common component of randomized clinical trials in recent years. METHODS: It is important to consider the implications of different approaches that are being used in various countries. IDMC guidelines in Korea, US, and Europe were reviewed and compared to provide the objective, composition and operation of IDMC in detail. RESULTS: IDMC is a group of experts in related subject are as who perform interim data monitoring to make a recommendation to the sponsor or organizer regarding appropriateness of trial continuation and the need for modifications of the trial. Independence of IDMC is preferred in order to minimize influence of factors unrelated to scientific, medical and ethical considerations that should underlie decision-making. CONCLUSION: IDMC has become an increasingly important component of clinical trials in recent years. Practical operating procedures need to be developed considering the future regulatory status of data monitoring committees.
