Key Takeaways
- Imaging provides an unbiased, structural assessment of many disease states, which is a complement to functional outcome measures
- Centralized imaging review is particularly important in Phase II and III trials where multiple imaging sites are involved
- Centralized imaging challenges can be mitigated with 1) imaging expertise, 2) standardization through certified QMS, and 3) an integrated technology platform
Why Imaging and Centralized Review Are Essential for Clinical Trials
Yijun Huang, PhD
MERIT Co-founder and CEO
Imaging is an integral part of many clinical studies, particularly in the fields of oncology and ophthalmology. Imaging provides an unbiased, objective, and structural assessment of many disease states, which is a complement to functional outcome measures. For example, standardized response measurement criteria such as RECIST 1.1 are used extensively in oncology clinical trials to define key endpoints and to complement outcomes such as Overall Survival Rate. Imaging plays a similar role in ophthalmology clinical trials as well, such as the use of OCT measurement of subretinal thickness to complement the functional outcome of Best Corrected Visual Acuity (BCVA).
“Centralized imaging review is particularly important in Phase II and III trials where multiple imaging sites are involved, said Yijun Huang, MERIT’s CEO. “A central reading center provides a rigorous imaging management process that standardizes the data efficiently and provides accurate and reproducible results for clinical studies.”
Images are collected from different sites around the world, standardized, and stored centrally. Then multiple readers review the images in a controlled manner to minimize inter- and intra-reader variability to ensure the imaging data are accurate and consistent across the entire study. This central imaging process is where MERIT can provide value for Sponsors.
Addressing Challenges in Imaging Clinical Trials
To deal with the challenges of imaging clinical trials, the following areas are of paramount importance. Centralized imaging services must include:
- Team of dedicated imaging experts
- Quality Management System (QMS) to standardize all processes and minimize variability
- Technology platform to tie everything together and make sure all stakeholders can work together seamlessly
MERIT’s Technology Platform and What It Offers to Partners
“MERIT’s technology platform EXCELSIOR™ was developed from the beginning as a single-platform, cloud-based solution to address the needs of large, multi-center, global clinical trials,” said Huang. “EXCELSIOR supports collection, processing, and reading of imaging data so that all stakeholders can work together effortlessly in the same platform in a traceable and reproducible way.”
In addition to EXCELSIOR being utilized in Phase II and III trials when central review is required, it is also useful for early Phase I studies where a Collect and Hold model is being employed. In those trials, the study Monitor or Medical Monitor can easily access the early reads through EXCELSIOR’s simple web-based login.
Advantages to MERIT Partnerships for Imaging Clinical Trials
Partnerships with MERIT provide the following advantages:
- Expertise in managing and evaluating images
- Standardization of data, readers, and interpretation
- Technology platform for stakeholders to work together with data transparency and accessibility
- Collaborative approach with nimble and attentive service for Sponsors