What is a Data Monitoring Committee (DMC)?
A Data Monitoring Committee (DMC), also known as a Data and Safety Monitoring Board (DSMB), is an independent group of clinical experts that monitors patient safety and/or treatment efficacy data during an ongoing clinical study. The most effective DMCs are populated with the proper expertise and ability to deliver timely analyses.
Why use a Data Monitoring Committee (DMC)?
Based on our extensive experience, we have found the use of Data Monitoring Committees especially 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.
What benefits have clients realized from using ACI’s DMC solutions?
Our DMC solutions have helped clients:
- Steer trials in the right direction
- Catch safety issues early on
- Assess and mitigate risk with aggregate safety profile
- Prevent incremental investment on trials without patient benefits/ commercial potential
- Bolster regulatory strategy prior to submission
- Gain an edge over competing products
Why does the industry trust ACI’s Data Monitoring Committee Services?
In just over a decade, ACI Clinical has specialized in the planning and management of hundreds of DMCs that harmonize with regulatory guidance, harness industry best practices and are populated with the world’s leading clinical/statistical experts. Each DMC is supported by a team with deep expertise and a proprietary technology platform that results in “easy to evaluate” data packages, streamlined operations and effective decision-making.