Need to select members for your data monitoring committee, but not sure exactly where to start? Explore criteria for DMC member selection, training for DMC members, and how to properly select your DMC Chairperson.
A Data Monitoring Committee (DMC), also referred to as an Independent Data Monitoring Committee (IDMC), Data and Safety Monitoring Board (DSMB), or Data and Safety Monitoring Committee (DSMC), is an independent group that evaluates clinical trial data on an ongoing basis. The primary responsibility of IDMCs is to safeguard the interests and safety of study participants and ensure the credibility and integrity of clinical trial results. As part of an Independent Data Monitoring Committee, committee members review available data to make informed recommendations to the Sponsor as to whether to continue, modify, or stop a trial due to safety concerns, overwhelming benefit, or treatment futility.
While DMCs are recognized as “advisory bodies” – with Sponsors holding final decision-making authority – survey findings from the Clinical Trial Transformation Initiative (CTTI) show that DMC recommendations are almost always (97% of the time) accepted (Calis et al., 2016).
As DMCs have a loud voice in whether a study continues or not, committee members must be diligently selected based on their relevant expertise and skillsets. The members of the DMC must also be fully aware of their responsibilities.
The trial Sponsor, CRO, or the study’s steering committee typically selects DMC members. While a DMC may vary in size depending on study needs, the committee must have no fewer than three members. Large, multicenter studies, or studies that require more detailed monitoring and interim analyses, may exceed this count.
DMC members typically consist of clinicians and at least one biostatistician (Lin & Lu, 2014). A second, non-voting biostatistician is also often included to serve as the committee’s unblinded support and a liaison between the Sponsor and the DMC.
A CTTI focus group of 72 DMC members noted that there are “no standards or guidelines pertaining to DMC members and their qualifications” (Calis et al., 2016). Several criteria should be considered before selecting a DMC member to participate in the study.
DMC members are suggested to have a breadth of expertise, allowing them to make meaningful recommendations based on any safety or efficacy issues that arise. For example, DMC members must have experience within the study’s indication or therapeutic area. It may also be important to bring in members who have experience with likely adverse events, which may fall outside of the disease-specific expertise.
Some criteria which may be helpful as sponsors consider DMC member selection include:
– Disease-Specific Expertise
– Education/Academic Position
– Ability to “Play Well with Others”
– Absence of Conflicts of Interest
– Ability to Interpret Complex Data
– Relevant publications
– Understanding of the DMC Process
– Review Experience
Despite the significance of a committee member’s role in the continuity of a clinical trial, CTTI has found that most DMC members have never received formal training concerning their roles and responsibilities.
In their survey, only 8% of DMC members indicated that they had been formally trained in the DMC process. A majority of the DMC members stated that they were unaware of any formal training (Calis et al., 2016).
Providing training for committee members who have never served on a review board before can help facilitate a straightforward DMC process and increase trust levels between Sponsors and the DMC members. The most significant barrier resulting from this lack of training is the inability of committee members to understand complex data and interpret it appropriately.
A DMC Chairperson is selected from the DMC membership to lead and manage all DMC meetings. This Chairperson provides leadership for the entire committee and may have considerable influence on the overall effectiveness of the DMC process.
Even more than the typical DMC member, the Chairperson must fully understand the DMC process to facilitate efficient and productive meetings.
In addition to the standard DMC member selection criteria, the following considerations may be important in the selection of a chairperson:
– Prior DMC experience
– Scientific expertise
– Ability to conduct and manage meetings
– Careful listening skills
– Leadership ability/ability to involve all members
– Ability to align differing perspectives
The DMC chairperson should take accountability for fostering communication and collaboration across members, ensuring all perspectives are included, and guiding the group towards a final consensus.
Members of the DMC evaluate accumulating study safety and efficacy data and serve as advisors to the Sponsor and project leadership. With such a responsibility, study DMC members must be chosen carefully to suit the needs of the trial. With years of experience, PharPoint has a database of potential DMC members that can be matched to your study.
For more information on DMCs and how PharPoint Research may be able to assist, please reach out to our business development team.
Sources:
Calis, K. A., Archdeacon, P., Bain, R. P., Forrest, A., Perlmutter, J., & DeMets, D. L. (2016). Understanding the functions and operations of Data Monitoring Committees: Survey and Focus Group findings. Clinical Trials, 14(1), 59–66. https://doi.org/10.1177/1740774516679665
Lin, J. Y., & Lu, Y. (2014). Establishing a data monitoring committee for clinical trials. Shanghai archives of psychiatry, 26(1), 54–56. https://doi.org/10.3969/j.issn.1002-0829.2014.01.009
Department of Veterans Affairs, Clinical Science Research & Development (CSR&D), Data Monitoring Committee Guidance (June 24, 2020)
RELATED RESOURCES
Preparing to work with a top biometrics contract research organization and wondering how their promised data management, biostatistics, and medical writing timelines match up to the industry average? To help sponsors dig into these details and ensure the timelines they’re receiving are competitive, we’re providing PharPoint’s typical timelines alongside research that calculates industry standard timelines, when available.
Our hope is that this document can help sponsors set realistic expectations, confidently ask the right questions of their vendors, and ultimately, partner with a top biometrics CRO that keeps their study moving: because patients are waiting.
PharPoint’s short eBook, Standard Clinical Trial Timelines: A Sponsor’s Guide to Evaluating Biometrics CROs, includes the below information.
For instant access to the eBook, fill out the form below.
RELATED RESOURCES