Third-Party Management May Be Best for Handling Expert Committees
Oversight of data monitoring committees (DMC) and endpoint adjudication committees (EAC) can be handled most effectively by specialty third-party providers that can help bolster trial credibility and productivity while cutting down on risk, bias and perceptions of bias, says one expert.
In an article published in the peer-reviewed Journal for Clinical Studies, David Cutler, director of project management for WCG’s EAC service line, advises sponsors to consider moving away from handling the management of DMCs and EACs in-house and through CROs and instead ship this critical task out to specialty providers.
While those first two avenues are feasible from an operational perspective, “they can create unnecessary risk, increased cost and operational inefficiencies,” Cutler says.
Providers that are pros at managing expert committees, on the other hand, may be the overall best choice “from a regulatory, ethical and business perspective” and can save sponsors time and money while guarding their relationships with key opinion leaders and industry experts, he says.
Sponsors that decide to take this route should ask potential providers some important questions on key topics, Cutler says, to ensure they’re selecting the right partner for the job.
- Timeline management: What mechanisms do they have to monitor timelines and ensure timelines are met, and do they have the resources to accelerate processes that will enable sponsors to hit key milestones?
- Member management: What is their experience in managing required expert committee tasks and actions to ensure timelines are met, what strategies do they use for this and how do they gauge member satisfaction and engagement?
- Audit support: What mechanisms do they use to answer questions from regulatory agencies, what is their experience hosting expert committee audits and how much support do they provide on audits?
- Reporting and data access: How will the client view status reports and results from committee(s) and how do they manage member spending reporting and payments?
- Staff expertise: What details can be provided about the project team that will be managing the committee(s), such as coverage plans and staffing size, to support the project as it grows in scale and is the staff dedicated specifically to working on expert committee projects?
“The right partner helps sponsors ensure clinical integrity and regulatory compliance, attain operational and financial efficiencies and achieve clinical trial success. When outsourcing expert committees, look for a provider who is as much an expert consultant as they are a provider managing the operational tasks of the project,” Cutler says. “Qualified providers should have a depth of experience managing expert committees and ensuring the project team has the required expertise and training is critical.”
In addition, Cutler stresses the importance of ensuring the sponsor and vendor are seeing eye-to-eye before trial startup. This can be achieved by:
- Aligning on the critical timepoints in the trial, including interim analyses, database locks and DMC meeting dates. Ensure that key milestones are documented with expectations.
- Identifying key decisionmakers. “When developing an expert committee, there are numerous documents, forms and systems that need to be reviewed and aligned between the sponsor and vendor. Ensure the right people are in the right discussions and approval processes up front to eliminate downstream issues,” he says.
- Identifying who’s in charge of what. The committee’s charter or project guidelines should outline roles and responsibilities and clearly and strategically draw lines between sponsor and vendor duties. Tasks and processes should be assigned to those with the most experience and expertise; using an EAC vendor that is highly experienced in EAC event identification, for instance, can deliver a clear, easily documented strategy for regulators.
- Defining communication and escalation pathways between the sponsor and provider at the beginning. “Is the process working as expected? Do the right people have access to vital information? Are delays or obstacles escalated to the appropriate parties to drive results? How is success measured and what does success look like? Use these data to drive results,” Cutler says.
- Clearly understanding who will need access to the adjudication results. Ask who will need to see the data and are there data transfer agreements in effect to ensure the appropriate party receives the data?
“Managing expert committees well takes expertise, effort and experience. EACs and DMCs are complex, and sponsors need a partner they can consult with, not merely a vendor who performs outsourced tasks,” Cutler said. “Sponsors need a specialty provider with committee expertise and years of regulatory and operational experience who can navigate those challenges, make recommendations and provide guidance.”
Access the full paper here.