Data monitoring committees and clinical endpoint committees can provide independent, expert review of study data and opinions to standardize outcomes and optimize data quality to help sponsors meet complex trial monitoring requirements.
As global, multi-center medical device studies become increasingly common, trial monitoring is growing more complex. Regulators require that sponsors perform site monitoring to ensure that investigators are compliant with federal regulations, sponsor agreements, investigational plans, and the requirements set forth by the study’s institutional review board. In addition, sponsors are responsible for ensuring monitoring methods to oversee the safety of trial participants. As part of this responsibility, they may use groups of independent experts to review study data and provide opinions on clinical safety or efficacy events of interest.
In this white paper, we will describe the key responsibilities of – and differences between – data monitoring committees and clinical endpoint committees and discuss how sponsors can best determine what type of study oversight is appropriate. We will also explore how an experienced contract research organization (CRO) can help navigate and simplify the complexity involved in appointing a committee.
Data monitoring committees
Data monitoring committees (DMCs) – also known as data and safety monitoring boards (DSMBs), data and safety monitoring committees, or independent data monitoring committees – are charged with providing an independent assessment of the safety, scientific validity, and integrity of a clinical trial. Their primary objective is to look at safety data, but they may examine efficacy data, concomitant medications, laboratory findings, and other data as well. The role of a DMC is to advise the sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial. This includes providing guidance on continuing, stopping, or changing a study.
Forming a DMC
The process of forming a DMC begins with identifying its members. Factors to consider in member selection typically include relevant expertise, experience in both clinical trials and serving on other DMCs, and absence of serious conflicts of interest. The objectives and design of the trial, along with the scope of the responsibilities given to the DMC, will determine the types of expertise needed for a particular DMC.