Amy Ghelardi | Vice President, Client Services, WCG ACI Clinical
Bill Stedman | Manager, Member Services, WCG ACI Clinical
Want a successful expert committee? Learn from members themselves.
Expert committee management is complex, and the stakes are high. The industry has seen trials unnecessarily stalled—or simply aborted—by mismanaged committees.
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?”
It’s a good question, so we decided to ask our network of 600+ experts who frequently sit on committees. These qualified and vetted expert clinicians and statisticians come from a well-balanced variety of backgrounds, geographic locations, and therapeutic specialties.
It begins with management
Committee management is crucial. Among the aspects raised by the medical experts we interviewed are the following:
- Set expectations: Give committee members detailed guidance on roles, responsibilities and operating procedure, all of which should be in the charter. Follow up with clear, timely communication. This ensures understanding and agreement on expectations and availability requirements, relative to trial duration expectations.
- Train: To avoid misunderstanding and to ensure expectations, it’s critical that members understand expectations 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: Experts want clear communication about expectations of what’s to be done when. Timely support and responsiveness from the management team is incredibly helpful in avoiding delays and meeting important timelines. The lack of timely response was a particular source of frustration to many who responded. By valuing their time and responding to their questions in a timely manner, a respectful and collaborative dynamic is created and sustained.
- 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 of those interviewed report that, in their estimation, smaller committees function better than large ones.
- Provide support: Many of the experts said they appreciate having strong administrative and/or secretarial support for the committee from the teams who support them and committee activities.
Planning the meetings
Committee members want regular, predictable meetings placed on the calendar well in advance. But that’s just the start.
- Distribute materials ASAP: 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 of our respondents, “needs to operate as one critical body.” Building this relationship among committee members can benefit from face-to-face contact, however time and budget doesn’t always allow for this.
- Set a cadence: 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 told us. 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.
- Include the admins: Ensuring good relationships with the experts’ internal support staff will foster smooth interactions with the experts, i.e. administrative professionals.
Getting paid, without hassle, was one of the strongest areas of consensus. Based on what we learned, it’s clear there are many potential challenges related to invoicing and payment of the experts.
It’s not merely a question of being paid. Eventually, even the slowest payer will compensate committee members. The larger issue, according to those we surveyed, 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 highly valued by the respondents.
Select the right members
The experts also had quite a bit to share about their fellow 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.
- Diverse subject-matter expertise: The best committees include diversity of backgrounds—e.g., statistical, medical, scientific, safety, ethical, etc. Each member should possess the requisite expertise in their area of specialty.
- Relevant knowledge: Each member should possess an understanding of regulatory framework and ethics as related to committee activity. In addition, each committee member should fulfill their assigned role while understanding the roles of the other members and processes as outlined in the committee charter.
- Intangibles: Not surprisingly, “ability to work well with others” was a common response. Other desirable characteristics mentioned 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 they seek 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 application in order to make the committee function smoother and stronger. The chair needs to listen to all viewpoints and not push his or her own agenda.
More than you think
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. In our experience, sponsors often don’t realize how much work is required to make that happen. If you’d like to learn more about what’s involved, visit us at https://www.wcgclinical.com/services/scientific-regulatory/.