Everything rests on having the right Data Monitoring Committee (DMC) in place. A well-run DMC protects patient safety and ensures data integrity. A poorly run one puts patients—and the trial itself—at risk.
DMCs are independent groups of experts, typically clinicians and statisticians, who monitor patient safety and sometimes treatment efficacy data during a clinical trial. They review unmasked interim data, determine whether the participants in a trial are safe, and decide whether the trial can continue as planned.
A DMC holds great power. It can recommend stopping the trial because of a serious safety concern or due to futility—lack of evidence of efficacy. This reduces the risk to trial participants, and it protects the sponsor from further investments in a product that may not work and/or harms patients. On the other hand, the DMC can stop the trial if the investigative product shows overwhelming efficacy, which means the product may get in front of the FDA or other regulatory body sooner. Because DMCs can identify safety—and sometimes efficacy—issues early in a trial, they can steer trials in the right direction, saving money and lives.
DMCs provide independent, unbiased recommendations to sponsors, thus enhancing trial integrity. By adding transparency, DMCs can also enhance trial credibility.
Not all DMCs are the same, however. Sponsors that want to protect trial participants and their investment need to make sure they have a well-run DMC.
A Well-Run DMC
How do you tell if a DMC is well run? Here are a few of the essential qualities:
A well-run DMC is independent: Sponsors may try to manage expert committees in-house or turn it over to a CRO. A sponsor or CRO in the middle of clinical trial simply won’t have the perspective an outside expert would. Independent data monitoring eliminates the potential for unintentional bias or the perception of bias.
A well-run DMC gets the administrative support it needs: Facilitating a DMC meeting requires resources, including an experienced staff that can deliver to members:
- Materials far enough in advance to prepare for each meeting
- Support for charter development
- Meeting minutes in a timely manner
- Communication about expectations, including timelines
- Prompt responses from the administrative team
- Compensation on time with no hassle
- Appropriate technology, including a safe, restricted location to share data with the DMC members while keeping the sponsor blinded to the study
A well-run DMC includes right experts: Selecting the members with appropriate expertise is a given. But for a DMC, other issues are just as important, including availability and experience working on DMCs or similar committees. You could have the top experts in an indication, but if they can’t meet the schedule or they don’t really understand what’s expected of them, they will hinder—even undermine—the process.
A well-run DMC provides quality statistical support: An informative yet succinct statistical report with appropriate quality control measures to ensure accuracy is of utmost importance in the DMC process; it’s imperative that the DMC can trust that the output they are reviewing is exactly what they need to make decisions.
A well-run DMC has the material it needs in the format it needs: Before each interim review, members need to receive all the relevant data and analysis, and it must be in the right format. This allows for a focused and effective review. Too often, DMCs receive a written summary and an array of tables. They’re told, “Here’s the output. Take a look and tell us what you think.” They may receive a concise summary and a pile of tables with no real context. This wastes time and money, and it increases the risk of missed signals.
A well-run DMC is transparent with proper controls in place: The data remains blinded for the sponsors while simultaneously unmasked for the DMC through an independent statistical reporting group. Meetings should be well run with transparent minutes that document DMC decisions. The output should be trustworthy with a clear quality control process, and provided in a format that is easy for a DMC member to review and interpret in a timely manner.
The Risks of a Poorly Run DMC
A poorly managed DMC may miss important safety and efficacy signals. This puts patients at risk and can lead to costly delays. Trials that should proceed quickly drag, and trials that should have been stopped continue. The potential cost in lives and money is staggering.
Ambiguity can be costly. You may have a terrific drug that will change lives, but an incorrect analysis could lead to delays, or worse. Even if a study isn’t stopped, problems with the DMC process can call into question the validity of the entire study.
That’s why it’s crucial to find a company that can ensure the DMC has access to all the relevant data that is presented in the right format.
Even smaller problems—such as scheduling or poor communication—can lead to unnecessary and costly delays. That’s why sponsors need an independent third-party that can manage the process well.
WCG helps sponsors find the appropriate experts for their Data Monitoring Committee. We can do this because of our virtual faculty—a global network of more than 950 medical, statistical, and safety experts representing more than 25 countries, 75 therapeutic sub-specialties and approximately 250 academic institutions. Just as important, we know which experts to match to which study.
Over the years, we’ve discovered experts enjoy working with us; they want to be part of our committees. They know we will handle all the administrative responsibilities, that we’ll respond to all their questions, and that we’ll pay them quickly.
Even more vital, they know they will get all the material they require when they need it. We provide the data they need in a format they can use. Graphics are integrated with text, and everything is in context. Think of it as an abbreviated clinical study report. This makes better use of their time and expertise; they don’t waste time digging through charts and tables.
WCG has a team of statisticians that have over 300 years of combined DMC experience under their belts. A client can rest assured that we provide them with the utmost statistical expertise across multiple therapeutic areas and have provided independent statistical supporting support with great attention to detail and accuracy.
DMCs that are run well protect patient safety, mitigate risks, and minimize delays. For more than 20 years, we’ve worked with sponsors, CROs, academic experts, and regulators to enhance trial integrity through well-run DMCs. To learn more, schedule a consultation.