September 8, 2019
As sponsors and CROs make increasing use of expert committees — especially Endpoint Adjudication Committees (EAC) and Data Monitoring Committees (DMC), they are asking, “What makes an expert committee successful?”
Who better to answer that question than the experts who have been there?
Respondents to a survey of WCG ACI Clinical’s network of experts had quite a bit to share on the subject of choosing the right committee members. They want their colleagues to have subject-matter expertise, of course. But they also want experience with clinical trials in general and expert committees in particular.
The best committees include members with diverse backgrounds, e.g., statistical, medical, scientific, safety, ethical, etc., respondents said. Each member should possess the requisite expertise in their area of specialty. Each member also should possess an understanding of regulatory framework and ethics as related to committee activity.
Not surprisingly, “ability to work well with others” was a common response. Committee members should understand the roles of other members as well as their own. Other desirable characteristics include flexibility and open-mindedness, being able to analyze risk-versus-benefit variables and a commitment to keeping the patients’ safety top of mind.
The characteristics respondents seek in a fellow committee member were the same one they want in a committee chair, but with particular expertise in dealing with sponsors and regulators. At least one member, usually a chair, should have excellent facilitator knowledge and should know how to listen to all viewpoints and not push his or her own agenda.
Respondents also weighed in on how payment for their committee work is handled. It’s not merely a question of being paid. Eventually, even the slowest payer will compensate committee members. The larger issue, according to respondents, is the hassle factor. Payments are late, or the process for getting paid is onerous. Committee members and their admins don’t need to become “armchair accountants.” They want a streamlined, efficient process that does not require extraordinary effort.
A consistent and clearly identified central point of contact to facilitate activity confirmation and payment was high on the list of characteristics valued by the respondents.
Respondents also value consistency in the planning of committee meetings. Committee members want regular, predictable meetings placed on the calendar well in advance. But that’s just the start.
Providing the right data in the right format at the right time is critical. Data and meeting presentation materials should be sent reasonably early to allow members to prepare. For EACs, adjudication systems that have a clear case package prepared are much easier to work with.
If possible, schedule some in-person meetings. It’s particularly useful at the beginning to schedule a face-to-face meeting to outline the roles, duties and responsibilities of the members. A committee, wrote one respondent, “needs to operate as one critical body.” Building this relationship among committee members is key.
Regardless of whether meetings are in person or remote, they need to be paced appropriately; long intervals between meetings require too much review of previous issues and data. “It’s nearly like starting over each time,” one expert respondent said. Touch-point communication and setting up obvious points of contact for committee members in between scheduled meetings is also helpful and practical to ensure smooth function.
And don’t overlook the admins. Ensuring good relationships with the experts’ internal support staff will foster smooth interactions with the experts.
Finally, respondents named several factors that contribute to efficient committee management, including:
- Set expectations: Give committee members detailed guidance on roles, responsibilities and operating procedures, all of which should be in the committee charter. Follow up with clear, timely communication.
- Make expectations clear: To avoid misunderstanding and to ensure expectations are met, it’s critical that members understand them before the first meetings. As one respondent noted, “Some issues could have been avoided if there had been training on the roles and expectations of a DMC.”
- Respond promptly: Experts want clear communication about what’s to be done when. Timely support and responsiveness from the management team is incredibly helpful in avoiding delays and meeting important timelines.
- Limit changes: Keep protocol changes to a minimum, especially when they pertain to inclusion/exclusion criteria and definition of outcomes. (The exception: adaptive design trials.)
- Think small(er): Many experts reported that, in their estimation, smaller committees function better than large ones.
- Provide support: Strong administrative and/or secretarial support for the committee is key to effective committee functioning, according to many respondents.
Sponsors expect a lot from expert committees, and the committee members expect a lot from sponsors. Managed well, these committees enhance trial integrity, improve efficiency, mitigate risks and ensure patient safety.
Amy Ghelardi is vice president of client services, and Bill Stedman is manager of member services at WCG ACI Clinical.
By Amy Ghelardi and Bill Stedman