Independent data monitoring committees (IDMCs) were introduced to monitor patient safety and study conduct in randomized clinical trials (RCTs), but certain challenges regarding the utilization of IDMCs have developed. First, the roles and responsibilities of IDMCs are expanding, perhaps due to increasing trial complexity and heterogeneity regarding medical, ethical, legal, regulatory, and financial issues. Second, no standard for IDMC operating procedures exists, and there is uncertainty about who should determine standards and whether standards should vary with trial size and design. Third, considerable variability in communication pathways exist across IDMC interfaces with regulatory agencies, academic coordinating centers, and sponsors. Finally, there has been a substantial increase in the number of RCTs using IDMCs, yet there is no set of qualifications to help guide the training and development of the next generation of IDMC members. Recently, an expert panel of representatives from government, industry, and academia assembled at the Duke Clinical Research Institute to address these challenges and to develop recommendations for the future utilization of IDMCs in RCTs.
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机译：引入了独立的数据监测委员会（IDMC）来监测患者的安全性和随机临床试验（RCT）中的研究行为，但是在IDMC的使用方面已经遇到了一些挑战。首先，IDMC的作用和责任正在扩大，这可能是由于审判的复杂性和医疗，道德，法律，法规和财务问题的异质性增加。其次，不存在IDMC操作程序的标准，并且不确定谁应该确定标准以及标准是否应随试验规模和设计而变化。第三，在IDMC与监管机构，学术协调中心和发起人的接口之间，沟通途径存在很大差异。最后，使用IDMC的RCT的数量已大大增加，但是还没有一套资格证书可以帮助指导下一代IDMC成员的培训和发展。最近，由政府，工业界和学术界的代表组成的专家小组在杜克临床研究所（Duke Clinical Research Institute）聚集在一起，以应对这些挑战并为将来在RCT中使用IDMC提供建议。
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