A Data Monitoring Committee (DMC) is an independent group of clinical experts that monitors patient safety and/or treatment efficacy data during an ongoing clinical study. A DMC, also known as a Data and Safety Monitoring Board (DSMB), provides an important and independent review of clinical data. The most effective DMCs require establishment of a committee with the proper expertise and ability to deliver timely analyses.
Use of a Data Monitoring Committee is especially thought to be helpful in the following situations:
- The study endpoint is such that a highly favorable or unfavorable result, or even a finding of futility, at an interim analysis might ethically require termination of the study before its planned completion;
- There are a prior reasons for a particular safety concern, as, for example, if the procedure for administering the treatment is particularly invasive;
- There is prior information suggesting the possibility of serious toxicity with the study treatment;
- The study is being performed in a potentially fragile population such as children, pregnant women or the very elderly, or other vulnerable populations, such as those who are terminally ill or of diminished mental capacity;
- The study is being performed in a population at elevated risk of death or other serious outcomes, even when the study objective addresses a lesser endpoint;
- The study is large, of long duration, and multi-center.
ACI Clinical’s Data Monitoring Committee Services
For more than a decade, ACI has specialized in the planning and management of DMCs that harmonize with FDA, EMA and ICH guidance on establishing and operating DMCs. Our experienced project teams work closely with our clients to identify and recruit the proper clinical and statistical experts while simultaneously preparing the presentation of the data package in an “easy-to-evaluate” clinician fashion.
ACI’s approach to facilitating and managing DMCs has been proven successful in hundreds of projects. Our team’s knowledge and experience with DMC processes is further leveraged by our portal technology. By combining these elements, ACI is able to provide rapid delivery of services in an efficient, user-friendly environment to DMC members, sponsors and CROs anywhere in the world. We consistently deliver on DMC best practices, and this is what makes our services cost-effective, easy to use, and highly rated by our client and committee members.
Fill out our New Project Request form to find out how we can support Data Monitoring Committees for your clinical development programs.