For many of today’s trials, the primary endpoint is a subjective assessment and depends on physician-rated or even patient-reported data, which means validation to the FDA and other regulatory agencies is automatically more difficult. For registration trials with subjective endpoints, blinded independent central review (BICR) of the trial data – including both images and other data such as laboratory and pathology data, autopsy reports, and physical descriptions – can be extremely valuable and may be executed through an endpoint assessment committee (EAC).

1. Endpoint Assessment Committee Services for
Blinded Independent Central Review
www.wcclinical.com
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2. Who We Are
• Headquarters: Boston, Massachusetts USA
• Founded in 1992 as part of the Massachusetts General
Hospital (MGH) Department of Radiology
• Extensive experience with independent review of imaging,
clinical and pathological data for multiple therapeutic areas
• Dedicated team composed of operations, regulatory,
statistical, imaging science experts partnered with
subspecialty trained MGH clinicians
• Multiple approvals for drugs and devices
• Successful audit history with regulatory agencies
www.wcclinical.com
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3. WCC Approach:
Unique Business Model
Massachusetts General Hospital
 Longstanding MSA with MGPO
 Leverage access to subspecialty
trained KOL with tertiary care
Strategic experience in radiology and other
clinical disciplines
Partners
+ = Superior
iCRO
Service
WorldCare Clinical
 Imaging Science
Core Capabilities  Regulatory Expertise
 Project Management Excellence
 Technology Driven Digital
Portal for Trial Management
 Subspecialty trained radiologists
 Extensive teleradiology experience
 Shared reading platform with WCC
www.wcclinical.com
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4. Precision and Accuracy
www.wcclinical.com
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5. Current Industry Challenges
• FDA is requesting BICR for EACs to
determine patient outcomes
• EAC’s determination is often positioned
as the primary efficacy endpoint in phase
3 trials
• All supportive data (e.g. imaging,
histology, pathology) must be interpreted
prior to EAC assessment
www.wcclinical.com
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6. EAC Design Considerations
• Need to maximize precision and accuracy
– Inferior design
• multi-disciplinary panel of experts
• consensus panel where often the loudest voice/highest
rank wins
• hard to train
• groupthink leads to incorrect conclusions
• single read
– Superior design
• members share a similar background & training (e.g.
oncologists)
• easier to train
• double blind read with adjudication
www.wcclinical.com
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7. Endpoint Assessment Committee (EAC)
A Melanoma Example
Radiology Images Clinical Listings
w/ Annotations & Measurements
Pathology Slides Othr Clinical
w/ Annotations & Measurements EAC Information
Dermatology CRFs
w/ Annotations & Measurements Radiology, Path, Derm
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8. For More Information
• Contact Rick Taranto at WorldCare Clinical info@wcclinical.com or
call:
– +1 (617) 583-1601
– (888) 816-4721
• Find out how to improve precision and accuracy with your next trial –
download our informative white paper: A “Second Opinion” for
Subjective Endpoints: BICR and Endpoint Assessment
Committees for Imaging and Beyond
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9. Thank you
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