Take Control of Your Clinical Trial:
How an Imaging Core Lab Can Help Overcome Common Study Challenges MERIT Webinar Key Takeaways

An Imaging Core Lab (ICL), or Clinical Endpoint Expert, can provide your team with the resources, knowledge, and experience that can help make your study a success. MERIT’s webinar discussed questions and answers that are important for oncology imaging clinical trials and provided insights on how an ICL can help you address imaging trial challenges.

WHAT IS AN IMAGING CORE LAB OR CLINICAL ENDPOINT EXPERT?

An ICL or clinical endpoint expert is a specialized type of Contract Research Organization (CRO) that focuses on providing the data to support a study’s endpoint(s). ICLs and Clinical Endpoint Experts provide the following to assist a sponsor in conducting a clinical trial:

• Image analysis services
  • Exam collection
  • Quality checks
  • Independent masked reads and analysis
• Pathway to regulatory approval
  • Phase II and III trials require an ICL for regulatory approval
  • 2018 FDA Guidance, “Clinical Trial Imaging Endpoint Process Standards: Guidance for Industry.”

STUDY CHALLENGES

Here are some of the common study challenges that threaten the success of an imaging study:

• Navigating agency guidance and response criteria
• Busy study sites
• Variation of image acquisition and interpretation across sites
• Status of subjects & timepoints
  • Where are timepoints in process?
  • Lack of visibility & transparency
  • Access to data and images
• Lack of central location for data

SOLUTIONS

Working with a clinical endpoint expert can provide the following solutions to common study challenges such as:

• Access to Subject Matter Experts & expert readers
  • Medical insight, support, and guidance
• Integrated, configurable, and flexible data system
  • Ease of use for busy study coordinators and CRAs
  • End-to-End Solution
  • Integrates published reading criteria with your protocol and study needs
  • Supports different read paradigms and workflows
• Focus on partnership & being an extension of your study team

When working with a Clinical Endpoint Expert, consider the software and systems they are using. Are they:

• Integrated and comprehensive?
• Cloud-based and accessible from many locations?
• Flexible and easy to use?

WHY ARE CLINICAL ENDPOINTS EXPERTS IMPORTANT FOR ONCOLOGY CLINICAL TRIALS?

Clinical Endpoint Experts can assist you with many key aspects of your clinical trial including:

• • Study Design
    • Expertise on reading criteria from SMEs (trained radiologists and oncologists)
    • Integrate and modify published reading criteria with protocol/study needs
    • Imaging design/clinical data collection
    • Clinical endpoints and surrogates
  • Study and Quality Assurance Documents
    • Imaging Charter
    • Site manuals
    • Reader training materials
    • Data Management
    • Reader Monitoring
  • Standardized Imaging Procedures
    • Provides imaging guidelines for the sites
    • Increases consistency in scan acquisition across sites
    • Monitors scan collection through queries and reporting
  • Imaging Modalities
    • Selecting imaging acquisition parameters
    • Schedule of assessments support data collection and analysis
    • Common modalities include CT, MRI, PET, Nuclear Medicine Bone Scans, PET/CT
  • Customized Read Paradigms
    • Design read paradigms that are appropriate to your specific protocol
    • Provide guidance on read response criteria appropriate for disease indication

• Guidance on Response Criteria
  • Navigate the complexities of choosing the right response criteria
  • What are response criteria? A specific set of rules and guidelines that is used when performing a read for a clinical trial. There are various response criteria published, and each is specific to a tumor type (e.g., RECIST 1.1 for solid tumors and RANO for gliomas). The response criteria will guide the reader in terms of lesion selection, measurement, and determining response.
  • Based upon indication/disease states, trial design, and therapeutic class of the agent
    • RECIST 1.1, iRECIST, irRECIST
    • RANO, MacDonald
    • Lugano
    • Other reading criteria and combinations
• Reduced Bias and Variability
  • Reduction of bias through uniform image evaluations across clinical sites by masked, independent readers
  • Minimize inter-reader and intra-reader variability through rigorous reader training and oversight

HIGHLIGHTS FROM Q & A

Q An Adjudicator is only needed if there is a disagreement in the reading results, correct?
A Yes, that is correct. An Adjudicator (a 3rd independent reader from the reader pool) will review both Radiology Reader 1 and Radiology Reader 2’s reads only if there is disagreement in the endpoint-related adjudication variable.

Q Why is the Imaging Charter such an important document?
A The Imaging Charter documents all the processes that guide the clinical endpoint expert – from acquiring the images from the sites to quality checking the exams to reading and transferring the data to the Sponsor/CRO. Even more importantly, it contains all the information related to the independent masked read, such as the response criteria.

Q What happens if the read results from the masked independent central review are different from the site review?
A During the study, we expect differences between the site and the central reviewer, which is commonly referred to as discordance. Some discordance is inevitable because the purpose of the site reads is clinical, for medical and treatment decisions for patients. The purpose of the centralized read is to provide endpoint data that is independent and standardized. Sponsors can compare site and central read results to see what level of discordance exists for their study and determine if further investigation or discussion is needed.

Q Our study requires novel/non-traditional imaging, and we are not quite sure what would be the best way to go about imaging collection and analysis. Would a clinical endpoint expert be able to help with this?
A Yes, partnering with an endpoint expert early in the study design process can help ensure the right imaging is built into your study and included in the schedule of assessments in your protocol. Our board-certified radiologists are subject matter experts and knowledgeable about different imaging modalities and techniques.

Q Our study requires novel/non-traditional imaging, and we are not quite sure what would be the best way to go about imaging collection and analysis. Would a clinical endpoint expert be able to help with this?
A Yes, partnering with an endpoint expert early in the study design process can help ensure the right imaging is built into your study and included in the schedule of assessments in your protocol. Our board-certified radiologists are subject matter experts and knowledgeable about different imaging modalities and techniques.

 
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