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Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities
Andrew J Buckler1, Linda Bresolin, N Reed Dunnick
1Buckler Biomedical, 13 Larch Row, Wenham, MA 01984, USA. andrew@bucklerbiomedical.com
Radiology
|February 18, 2011
Summary
Developing quantitative imaging biomarkers requires understanding regulatory pathways. This article proposes a flexible framework to efficiently develop and utilize these biomarkers for improved treatments and clinical care.
Area of Science:
- Medical imaging
- Biomarker discovery
- Regulatory science
Background:
- Quantitative imaging biomarkers (QIBs) show potential for accelerating new treatment development and enhancing clinical care.
- Challenges exist in understanding the interplay between regulatory and non-regulatory pathways for QIBs.
- Efficient data collection to support diverse QIB development pathways is not well-defined.
Purpose of the Study:
- To outline current stakeholder perspectives on QIB pathways.
- To propose streamlined processes for QIB development and implementation.
- To facilitate the efficient definition, validation, and qualification of QIBs.
Main Methods:
- Review of current thinking from diverse stakeholders.
- Proposal of a flexible, adaptable framework for QIB development.
- Mapping of processes applicable to imaging product and QIB development.
Main Results:
- A flexible framework is described for adapting to various imaging applications.
- Mechanisms are provided for developing, assessing, and evaluating relevant biomarkers.
- Processes are outlined for both imaging product and QIB development.
Conclusions:
- The proposed framework and processes can aid in the effective development and use of QIBs.
- This approach aims to increase the effectiveness and availability of quantitative imaging.
- Streamlined QIB development can accelerate medical innovation and improve patient outcomes.
