An Endpoint Adjudication Committee (EAC), also known as a Clinical Endpoint Committee (CEC), is an independent group of experts that reviews clinical trial data in order to give expert opinions about clinical safety or efficacy events of interest. Endpoint Adjudication can be a critical aspect of a clinical trial as it can help to lower the risk of variation in important clinical trial outcome events for submission to regulatory agencies. From a global perspective, Endpoint Adjudication reduces regional variation in outcome reporting and also serves as a quality control check through clinical expert review of principal investigator reporting.

The independent adjudication process is used to make sure that reliable, consistent definitions are provided to regulators and the scientific community, which is especially thought to be helpful in the following situations:

  • Studies with complex and/or subjective endpoints;
  • Studies which cannot be blinded;
  • Studies with high enrollment or long duration;
  • Studies with global or cultural differences across sites;
  • When the endpoint of interest differs from the therapeutic specialty of the investigator.

ACI Clinical’s Adjudication Services
As an industry leader in Endpoint Adjudication Committee (EAC) management, ACI Clinical brings clients the largest committee dedicated staff in the industry, our own global network of more than 500 vetted medical experts who can serve as committee members or expert advisors to clients, and a proprietary end-to-end adjudication technology designed specifically for efficient, user-friendly adjudication workflows.

ACI’s executive leadership remains deeply involved in public-private thought leadership efforts that focus on shaping adjudication best practices. We work with clinical trial sponsors, academic experts and regulatory agencies to focus on providing the best independent committee solutions on the market to enhance trial integrity and reduce variation in important clinical trial events.

Adjudication Best Practices
ACI Clinical’s Adjudication solutions are largely focused on the proper establishment of the adjudication process. In order to provide consistent and efficient adjudication services, we have created detailed “Best Practice Guides” to help clients navigate through the critical decisions that should be made upfront in the design of the process. Additionally, ACI structures our adjudication processes around current regulatory thinking. ACI’s president, Dr. Jonathan Seltzer, authored a publication alongside FDA and EMA representatives that include several recommendations for adjudication process that we include in ACI’s standard practices:

  1. Prospective approach to adjudication
  2. Independent voting processes
  3. Comprehensive search strategy for potential events
  4. Standardized event definition CRFs
  5. Adjudication of events when an unanticipated safety signal arises in a clinical development program
  6. At least three EAC members with knowledge of the geographic variations of care represented in the trial
  7. Independence from sponsor
  8. Consideration of risk-based or adaptive adjudication models

Industry Leading Metrics
As part of ACI’s mission to be an industry leader in Endpoint Adjudication services, we believe in tracking ourselves against performance metrics and making these transparent to our clients. Our staff’s expertise in adjudication process along with their deep experience working across so many client therapeutic areas allows us to continually beat our own records and consistently deliver on our performance targets:

  • 2 day case turnaround from source receipt to action
  • Average 5 days from posting to adjudicator decision
  • 100% on time final adjudication database lock (DBL) prior to final study DBL
  • Average 32 days for entire adjudication process

ACI frequently reviews our metrics on a regular basis throughout the adjudication process.

Shortly after adjudication begins we review:

  • Voting concordance
  • Case averages
  • Quality of data
  • Variability between interruption of charter definitions

After making changes to the adjudication process we may recommend changes including:

  • Adding additional member to EAC
  • Major Charter changes
  • Adding new events to list of events for adjudication

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