Independent Data Monitoring Committees: Review of Current Guidelines

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.

General considerations on adaptive designs for clinical trail and drug evaluation / 中国临床药理学与治疗学

Adaptive design is a trial design that allows modifications to some aspects of the trial after its initiation without undermining the validity and integrity of the trial. Adaptive design makes it possible to discover and rectify inappropriate assumptions in trial designs, reduce development costs and the time to market. It has been very attractive to the pharmaceutical industries. In this paper, it is not focused on adaptive designs for clinical trials with multiple endpoints studied using computer simulations, but is to clarify our evolution, which is taken into consideration in a trial adaptive design at present, if need modifications.