Adjudication Committee Services
For more than 20 years, WorldCare Clinical has provided Endpoint Adjudication Committee (EAC) services for review of clinical trial data.
Our endpoint adjudication committees provide a standard assessment of safety and efficacy of pharmacologic or device therapies in clinical trials.
With our extensive experience, we can seamlessly incorporate a study’s clinical trial data for review by one of our standing committees:
- Gastrointestinal Perforation
- Macrophage Activation Syndrome
- Opportunistic Infection
We can also establish and manage custom committees for your particular trial’s data.
Our process includes a set of module components that include hand picking top experts as committee members, planning the control schema for the assessment and providing fully digital evaluations.
Primary efficacy and safety endpoints are often subjective assessments made by site personnel. For international registration trials conducted over broad geographic regions and different clinical practice settings, variability in these subjective assessments can result in a loss of precision and accuracy. Centralized endpoint adjudication committees (EACs) offer a mechanism to remove treatment bias in open labeled trials and potentially increase the precision and accuracy of the assessment.
While no specific FDA guidance documents have been issued regarding the use of EACs and blinded independent central reviews (BICRs), WCC, in collaboration with Drs. Glenn Bubley, associate professor of medicine at Harvard Medical School and director of genitourinary oncology at Beth Israel Deaconess Medical Center, and Bin Yao, director of biostatistics at Amgen has published a review article which can be used as a process map for perform a central assessment of non-imaging clinical data.
We recommend that when clinical site data interpretation is variable and results of measurements are important to trial success, a BICR can provide consistent results through verifiable and uniform reader training as well as ongoing management of reader performance.
Types of EAC
All phases of a trial can benefit from an EAC, from eligibility and on-study determination of safety and efficacy to overall patient status. Most of our EACs consist of sophisticated, fully digital evaluations using multiple BICRs rather than the panel review approach.
We offer EACs for all subjective clinical endpoint such as:
- determination of response and/or disease progression status in cancer trials
- safety reviews (clinical events committees) which focus on major adverse cardiac events (MACE) and malignancy detection in non-oncology trials.