Guideline on Clinical Trial Data Monitoring Committees (Draft for public review)非劣效设计临床试验指导原则（征求意见稿）.docx

PAGE 3 Guideline on Clinical Trial Data Monitoring Committees (Draft for Public Review) Center for Drug Evaluation, NMPA September, 2019 PAGE 1 Table of Contents TOC \o "1-3" \h \z \u 1. Introduction 1 2. DMC Responsibilities and Tasks 1 2.1. Safety Monitoring 2 2.2. Efficacy Monitoring 2 2.3. Study Conduct Monitoring 3 2.4. Recommendations for Modifications of Trial Designs 3 2.5. Evaluation of Regional Effects in Multi-regional Clinical Trials (MRCTs) 3 3. Establishment of DMC 4 3.1. Composition of DMC 4 3.2 Independence of DMC 5 3.3 Avoiding Conflicts of Interest 5 4. DMC Operation 6 4.1. Developing DMC Charter 6 4.2. DMC Meetings 6 4.3. Making Recommendation 8 4.4. Meeting Minutes 9 5. Statistical Considerations during DMC Operation 10 5.1. Interim Analysis Plan 10 5.2. Role of Statisticians in DMC Operation 10 6. DMC Interaction with Relevant Parties 11 6.1. DMC Interaction with Sponsor 12 6.2. DMC Interaction with Independent Statistical Team 12 6.3. DMC Interaction with Regulatory Agencies 12 References 14 Glossary 15 Guideline on Clinical Trial Data Monitoring Committees Introduction In clinical trials, it should be ensured that the subjects in the trial do not bear unnecessary risks due to ethical reasons. On the other hand, it is also important to ensure that the trial is not terminated prematurely to answer the preset scientific questions. Therefore, clinical trials sometimes require the establishment of Data Monitoring Committees (DMCs) to undertake these tasks. A DMC is an independent expert group with relevant expertise and experience to regularly review accumulating data from one or multiple ongoing clinical trials in order to ensure the safety of subjects in clinical trials, as well as the validity and scientific merit to continue the trials. The DMC is also referred to as the Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC). For