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A risk management approach for imaging biomarker-driven clinical trials in oncology
Yan Liu1, Nandita M deSouza2, Lalitha K Shankar3
1European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.
Abstract:
Imaging has steadily evolved in clinical cancer research as a result of improved conventional imaging methods and the innovation of new functional and molecular imaging techniques. Despite this evolution, the design and data quality derived from imaging within clinical trials are not ideal and gaps exist with paucity of optimised methods, constraints of trial operational support, and scarce resources. Difficulties associated with integrating imaging biomarkers into trials have been neglected compared with inclusion of tissue and blood biomarkers, largely because of inherent challenges in the complexity of imaging technologies, safety issues related to new imaging contrast media, standardisation of image acquisition across multivendor platforms, and various postprocessing options available with advanced software. Ignorance of these pitfalls directly affects the quality of the imaging read-out, leading to trial failure, particularly when imaging is a primary endpoint. Therefore, we propose a practical risk-based framework and recommendations for trials driven by imaging biomarkers, which allow identification of risks at trial initiation to better allocate resources and prioritise key tasks.
Insights
Clinical cancer research faces challenges with imaging biomarker integration in trials. A new risk-based framework aims to improve trial design and data quality for better outcomes.
Area of Science:
- Oncology
- Medical Imaging
- Clinical Trials
Background:
- Imaging techniques are advancing in cancer research, but their integration into clinical trials faces significant hurdles.
- Current trial designs and data quality are suboptimal due to a lack of optimized methods, operational constraints, and limited resources.
- Integrating imaging biomarkers is complex, involving challenges in technology, contrast media safety, multi-vendor standardization, and post-processing.
Purpose of the Study:
- To address the identified gaps and challenges in utilizing imaging biomarkers within clinical trials.
- To propose a practical, risk-based framework to enhance the quality and reliability of imaging data in cancer research.
- To provide recommendations for optimizing trial design and resource allocation when imaging is a key component.
Main Methods:
- Development of a risk-based framework tailored for clinical trials incorporating imaging biomarkers.
- Identification of potential risks at the trial initiation phase.
- Recommendations for resource allocation and prioritization of key tasks.
Main Results:
- The proposed framework facilitates early identification of risks associated with imaging biomarker integration.
- It enables better allocation of resources and prioritization of critical trial activities.
- Implementation of the framework is expected to improve the quality of imaging read-outs and reduce trial failures.
Conclusions:
- A proactive, risk-based approach is essential for successful integration of imaging biomarkers in clinical trials.
- Addressing the complexities of imaging technologies and standardization is crucial for robust trial outcomes.
- The proposed framework offers a practical solution to mitigate risks and enhance the value of imaging in cancer research.
