From research to regulated: challenges in transferring methods
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Updated: Jun 6, 2026

Working with Human Tissues for Translational Cancer Research
Published on: November 26, 2015
Ferdousi Chowdhury1, Anthony Williams
1CRUK Clinical Centre, Somers Cancer Research Building, University of Southampton, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD, UK. f.chowdhury@soton.ac.uk
Abstract:
The current decade has seen an evolution in biomarker research, with a breakthrough from traditional single analyte studies to simultaneous multiple analyte technologies, aided by the progressive development of research tools and the discovery of many novel biomarkers. It is foreseeable that the application of such technologies will have an integral role in clinical studies for establishing biomarker profiles of disease status and prognosis. However, the transfer of such complex procedures to a regulated environment presents many obstacles. Here, we discuss some of these applied technologies and the validation approaches we have taken as an academic unit to prove their suitability and appropriateness for clinical application. We discuss the advantages and limitations for such end point assays in early Phase clinical trials.
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