What is a Data Monitoring Committee?

A Data Monitoring Committee (DMC) comprises a multidisciplinary group of experts who periodically assess the accumulating safety and, where applicable, efficacy data of an ongoing clinical trial. The DMC protects the safety of participants and the scientific integrity of the study, advising the sponsor on study modification, continuation or termination. To avoid bias the DMC is external to the trial and independent of the sponsor.

Not all trials need a DMC, but where they do the DMC allows the sponsor and investigators to fulfill their responsibilities in overseeing the conduct of the trial whilst protecting the integrity of the trial and maintaining the blind.

Why use a Data Monitoring Committee?

It may not be ethical to wait until the end of the trial before assessing the efficacy and safety of the treatments under study, such that interim assessments are required to protect the safety of ongoing and future trial participants. Another example is where a study may have preplanned interim analyzes to support decisions on early stopping (either for futility or positive efficacy) or design adaptation (for example dropping a treatment in an umbrella design), requiring assessment of unblinded results whilst the study overall is blinded. To avoid the potential for bias or undue influence on subsequent trial conduct, an independent Data Monitoring Committee is used for such interim monitoring of unblinded/aggregate safety and efficacy results.

A DMC requires administrative and logistical support to set up, timely access to relevant (usually unblinded) analyzes of accumulating study data during the study, and statistical support. These should also be independent of the sponsor, and are services we can provide.

As a Statistical Data Analysis Center we collaborate with the sponsor on the setup of the DMC, independently support the DMC with integrity throughout the trial by providing the required analyzes securely through our independent statistician, and at closeout deliver the files and documentation required for the trial masterfile.

Our statisticians and programmers have experience supporting DMCs in this way across a range of therapeutic areas and logistical scenarios, understand the issues inherent in providing analyzes for interim decision making on incomplete and often unclean data, and are practiced in ensuring data quality and alignment of DMC and main study analyzes whilst maintaining study blind. Our independent statisticians are “hands-on”, developing the deep knowledge of the study and data necessary to oversee reporting to the DMC. Our technology, processes and robust approach to quality ensure effective delivery without compromise.

As a part of our end-to-end service, we are able to take on the burden of administrative and logistical support for the DMC. For example, we can set up and host virtual DMC meetings, make logistical arrangements for secure face to face meetings, manage secure file transfer and storage as well as manage and organize the on-going project management of the DMC process.

Where not otherwise involved in a study we can provide statisticians who are experienced in performing the role of the statistical member of the Data Monitoring Committee (voting or non-voting).