title: From research to regulated: challenges in transferring methods.
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.
authors.affiliation: CRUK Clinical Centre, Somers Cancer Research Building, University of Southampton, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD, UK. f.chowdhury@soton.ac.uk
authors.forename: Ferdousi
authors.initials: F
authors.lastname: Chowdhury
authors.forename: Anthony
authors.initials: A
authors.lastname: Williams
mesh_terms: D015415:Biomarkers / Q000032:analysis*; D035843:Biomedical Research / Q000379:methods*; D002623:Chemistry Techniques, Analytical; D002986:Clinical Trials as Topic; D017277:Drug Approval; D006801:Humans; D013677:Medical Laboratory Science; D011379:Prognosis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D057170:Translational Research, Biomedical
chemical_list: D015415:Biomarkers