Endpoint Adjudication Services
Secure Independent Evaluation and Adjudication of Complex Clinical Trial Endpoints
Whether you need assessment from one medical expert or an endpoint adjudication committee (EAC), Advarra’s worldwide network of medical and clinical research professionals have the experience to independently assess and advise on clinical drug and device trial endpoints.
Advarra provides trusted oversight of clinical drug and device trials needing independent endpoint adjudication consistent with US FDA and EU EMA guidelines.
Why Advarra Adjudication
Accelerate Study Startup
Minimize delays and leverage our worldwide network of medical experts for the rapid creation of the EAC charter and evaluation plan.
Improve Independence
Whether the trial requires just one independent medical expert or multiple EAC members, endpoint adjudication must be independent of the sponsor per US FDA and EU EMA guidelines. Ensure independence when you separate clinical trial oversight from trial execution and conduct.
Unmatched Experience
Leverage Advarra’s global reach to ensure appropriate expertise. Our EACs are comprised of world-leading experts with the technical prowess to evaluate the most challenging endpoints and the experience to understand the various comorbidities, and confounding variables present in complex clinical trials.
Optimize Compliance
Save time and resources with truly integrated review services. While the review committees are separate, Advarra coordinates all the institutional review board (IRB), institutional biosafety committee (IBC), data monitoring committee (DMC), and EAC reviews to reduce delays and ensure consistency.
Secure | Compliant | Audit-ready | Flexible
Advarra’s platform for safety oversight administration and reporting provides connectivity and role-based transparency for all parties involved in an Advarra administered EAC/CEC.
SOAR is compatible with any electronic data capture (EDC) or similar clinical records system and configurable to handle sophisticated adjudication determinations with parallel, sequential, and other complex determination workflow types.
SOAR offers one integrated, easy-to-navigate platform for:
- Dynamic exchange of medical information and records, including images
- Re-time redaction of personal information
- Dynamic translation of materials through Advarra’s integrated translation vendor
- Assembly and submission of complex dossiers
- Management of queries
- Review of data packages
- Management of open and closed session non-conformance meetings
- Return of adjudication assessments
- DICOM viewer integration
- Complete audit trail and secure audit ready document repository
- And more
When Is Endpoint Adjudication Required?
Independent endpoint adjudication review and oversight are essential when trial endpoints are complex, and some degree of medical judgment is needed to determine if a participant has met a protocol-defined endpoint or not. Endpoint adjudication is also used when specific therapeutic expertise is needed beyond that of the principal investigator or sponsor’s medical monitor. Guidance from US FDA indicates an independent EAC is an effective and appropriate piece of the overall safety monitoring plan for complex clinical drug and device trials.
Establishing an EAC independent of the sponsor or contract research organization (CRO) conducting the research is also an effective way to mitigate the potential for bias in trial results as well as infuse additional public and regulatory agency trust into the clinical trial process.
Learn about the process of establishing an independent EAC.
Medical Expertise for Every Program
With a worldwide network of over 1,500 medical experts, biostatisticians, and other clinical professionals, Advarra has deep expertise in all therapeutic areas, trial designs, and complex endpoints.
We work with you to determine the right membership for your endpoint adjudication committee while operating independently to eliminate any appearance of conflict.
Want to Become an Endpoint Adjudication Committee Member?
Advarra is always seeking additional experienced medical experts to serve on our committees. Committee members across the world assist on a part-time basis with endpoint evaluations and EAC reviews.
Endpoint Adjudication Services
- Independent committee formation administered by Advarra
- Collaborative development of EAC plan/charter and member selection with a sponsor or CRO
- Recruitment and staffing of qualified medical experts
- Secure data exchange management
- Establishment of secure data transfer
- Realtime or scheduled committee review of endpoints per EAC plan
- Active collaboration with sponsor/CRO on safety or design issues
- Rapid production of EAC recommendations and report to sponsor/CRO
- On demand meeting services
- Sponsor/CRO training on the endpoint adjudication process
- Data safety monitoring plan and endpoint development consulting for clinical protocol
- Biostatistical design consulting for efficient endpoints
Endpoint Adjudication FAQ
What is an EAC?
An EAC is an independent group of experts who evaluate trial data to determine if participants have met protocol-defined endpoints. Complex clinical trials often require professional judgment to determine if an event meets an endpoint or if it was caused by underlying medical conditions, comorbidities, and other environmental factors.
The number of participants meeting an endpoint is critical to evaluating the safety and/or efficacy of a new therapeutic compound or device. Recruiting an outside independent event assessment rather than a sponsor or CRO adds data credibility and helps eliminate any bias perception. The key to an effective EAC is truly independent members. EAC members should not have conflicts of interest potentially compromising an unbiased review and recommendation to the sponsor.
What is the difference between an EAC and a clinical events committee (CEC)?
The terms endpoint adjudication committee (EAC) and clinical events committee (CEC) are essentially synonymous and used interchangeably. The US FDA guidelines use the EAC’S terminology; however, in practice, these committees are occasionally referred to as CECs or clinical events evaluation committees (CEEC).
What is an EAC charter?
The charter defines the overall adjudication plans, specific determinations, and procedures the adjudicators and committee will follow. Each clinical trial is unique, so the adjudication plan for an EAC overseeing the trial is created with that specific trial in mind. The charter outlines, among other key elements, how the EAC adjudicators will conduct their reviews, how to summarize reviews for the committee membership, committee membership requirements, meetings and review timelines, and most importantly, the specific methods used to prepare medical and endpoint data for the committee to review.
At Advarra, the charter is created collaboratively with the sponsor or CRO and is a key part of our rapid EAC startup process.
Who serves on an EAC?
Regulatory agency guidelines do not mandate a specific committee composition. Advarra EACs follow industry best practices and are typically comprised of:
- Three or more total members who collectively have the medical and clinical expertise to assess the endpoint events associated with the clinical drug or device trial.
- At least one member who is an experienced clinician in the therapeutic area.
- At least one member with scientific or medical expertise to evaluate the event.
- At least one non-scientifically trained member to represent the general perspective of research participants
EAC membership varies based on the nature of the protocol, and final membership demographics are outlined in the EAC charter in collaboration with the sponsor or CRO.
Turnaround Time
During the trial, the EAC reviews participant medical information to determine endpoint applicability at the frequency outlined in the charter. Depending on the charter, Advarra will provide the EAC’s recommendations to the sponsor/CRO in a timeframe appropriate for participant safety and dosing decisions.
Setup time for your study’s EAC will depend on the nature of the trial and the complexity of endpoint determinations made by EAC members. Typically, this process takes a month or more, and is completed in advance of study activation and first patient first visit. The sooner you start the process, the less likely it will impact to study startup.
Related Resources
Multiple Dynamic Endpoints and the Role of Endpoint Adjudication Committees in Clinical Trials
Trial designs incorporating multiple endpoints to support efficacy are receiving increased focus from the FDA, including a recently published guidance.
What Does an Endpoint Adjudication Committee (EAC) Do?
This white paper discusses an endpoint adjudication committee's (EAC) role in clinical research and the basics of setting up an EAC.
Endpoint Adjudication Services Info Sheet
Advarra's endpoint adjudication services secure independent evaluation and adjudication of complex clinical trial endpoints.
