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Updated: May 26, 2026
Registered Bioimaging of Nanomaterials for Diagnostic and Therapeutic Monitoring
Published on: December 9, 2010
Qualification of imaging biomarkers for oncology drug development
John C Waterton1, Liisa Pylkkanen
1AstraZeneca, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK.
Abstract:
Although many imaging biomarkers have been described for cancer research, few are sufficiently robust, reliable and well-characterised to be used as routine tools in clinical cancer research. In particular, biomarkers which show that investigational therapies have reduced tumour cell proliferation, or induced necrotic or apoptotic cell death are not commonly used to support decision-making in drug development, even though such pharmacodynamic effects are common goals of many classes of investigational drugs. Moreover we lack well-qualified biomarkers of propensity to metastasise. The qualification and technical validation of imaging biomarkers poses unique challenges not always encountered when validating biospecimen biomarkers. These include standardisation of acquisition and analysis, imaging-pathology correlation, cross-sectional clinical-biomarker correlations and correlation with outcome. Such work is ideally suited to precompetitive research and public-private partnerships, and this has been recognised within the Innovative Medicines Initiative (IMI), a Joint Undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations, which has initiated projects in the areas of drug safety, drug efficacy, knowledge management and training.
Insights
Developing robust imaging biomarkers for cancer research is crucial. Current challenges include standardizing validation and correlating imaging with pathology and patient outcomes, necessitating collaborative efforts.
Area of Science:
- Oncology
- Medical Imaging
- Biomarker Discovery
Background:
- Many imaging biomarkers exist for cancer research, but few are clinically validated for routine use.
- Key pharmacodynamic effects like reduced proliferation or induced cell death lack robust imaging biomarkers.
- There is a critical need for validated biomarkers to assess metastatic potential.
Purpose of the Study:
- To highlight the challenges in qualifying and validating imaging biomarkers for clinical cancer research.
- To emphasize the need for robust biomarkers for assessing drug efficacy and metastatic propensity.
- To advocate for collaborative research models to advance imaging biomarker development.
Main Methods:
- The abstract discusses the general challenges and requirements for imaging biomarker validation.
- It implies a review of current limitations and proposes solutions through collaborative research.
- Specific technical methods are not detailed, but the need for standardization and correlation is stressed.
Main Results:
- Few imaging biomarkers are currently robust and reliable enough for routine clinical use in cancer research.
- Significant challenges exist in standardizing acquisition, analysis, and correlating imaging data with pathology and clinical outcomes.
- The need for validated biomarkers for drug development and metastasis prediction is unmet.
Conclusions:
- The qualification and validation of imaging biomarkers present unique challenges compared to biospecimen biomarkers.
- Addressing these challenges requires standardization, robust correlation studies, and is well-suited for precompetitive research and public-private partnerships.
- Initiatives like the Innovative Medicines Initiative (IMI) are crucial for advancing imaging biomarker development in drug safety and efficacy.
