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Determining if an EAC is at risk and key actions to mitigate trial impact.
There are times when problems arise, and a sponsor needs to determine if its adjudication committee needs to be rescued. This article examines early indicators of risk for adjudication committees, common reasons why adjudications are rescued, mitigation steps, and indications when it is time to seek additional expertise. It shares insights regarding additional measures that can be taken to set a committee up for success and put a trial back on track.
Endpoint adjudication committees (EACs) are independent bodies of experts that provide a consistent, objective, and unbiased assessment of safety and efficacy events during a clinical trial. As the EAC needs to be independent from sites, participants, and the sponsor, it can prove challenging to determine whether the EAC is on track or at risk, and thus placing the trial at risk.
Adjudication processes often add a level of complexity into trial conduct and without expert management, they may impact sites, vendors, and the study analysis. Many companies do not have experts in adjudication on staff, since not enough trials need adjudication, and as a result, sponsors often look to outside experts to manage their EACs.
Challenges arise if an EAC is not managed properly, or the workflows required to provide complete data to an EAC are incorrectly managed. Uncovering those challenges is critically important. Sometimes for instance, a charter submission deadline may be missed, and adjudication never begins, resulting in a growing backlog of events that will require adjudication. The EAC provider may experience ongoing and significant changes to the charter, high rates of member discordance, and missed deliverables to the sponsor or vendors that require access to the adjudication results. If delays continue, timelines will shift, and costs will rise. It is essential that an EAC provider has the requisite expertise, access to an expert network, and the tools and infrastructure necessary to deliver adjudication documents and technologies simultaneously.
The most common reason why an EAC needs to be rescued is improper management of the committee members, adjudicated data, and overall EAC process and workflow. This may result from a vendor managing multiple trial activities, including the EAC, without adequate staff or experience or more complex projects, which require expertise in that space, taking precedent. Regardless of the reason, improper management of the EAC may impact multiple workflows, vendors, sites, and the sponsor. Common signs and symptoms of poor EAC management include:
The adjudication system plays a critical role in the entire adjudication management process and workflow and should be assessed from the perspective of each user on the platform. The technology should:
Many sponsors face challenges with their EAC but are unable to pinpoint their exact cause or struggle to determine whether they should try to salvage the existing committee and vendor relationship or move their EAC to a new provider. There are many factors to consider, which usually require outside expertise, to determine the right steps for the trial.
It is recommended that sponsors seek additional expertise to assess the state of their EAC, identify risks, and form a plan to ameliorate the pain points. This may be achieved by requesting that a separate team from the current vendor performs a risk assessment, or more commonly, seeking a different provider with adjudication expertise to help uncover risks and form a plan to put the EAC and trial back on track.