title: (Very) Early technology assessment and translation of predictive biomarkers in breast cancer.
abstract: Predictive biomarkers can guide treatment decisions in breast cancer. Many studies are undertaken to discover and translate these biomarkers, yet few biomarkers make it to practice. Before use in clinical decision making, predictive biomarkers need to demonstrate analytical validity, clinical validity and clinical utility. While attaining analytical and clinical validity is relatively straightforward, by following methodological recommendations, the achievement of clinical utility is extremely challenging. It requires demonstrating three associations: the biomarker with the outcome (prognostic association), the effect of treatment independent of the biomarker, and the differential treatment effect between the prognostic and the predictive biomarker (predictive association). In addition, economical, ethical, regulatory, organizational and patient/doctor-related aspects are hampering the translational process. Traditionally, these aspects do not receive much attention until formal approval or reimbursement of a biomarker test (informed by Health Technology Assessment (HTA)) is at stake, at which point the clinical utility and sometimes price of the test can hardly be influenced anymore. When HTA analyses are performed earlier, during biomarker research and development, they may prevent further development of those biomarkers unlikely to ever provide sufficient added value to society, and rather facilitate translation of the promising ones. Early HTA is particularly relevant for the predictive biomarker field, as expensive medicines are under pressure and the need for biomarkers to guide their appropriate use is huge. Closer interaction between clinical researchers and HTA experts throughout the translational research process will ensure that available data and methodologies will be used most efficiently to facilitate biomarker translation.
authors.affiliation: Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, The Netherlands.
authors.forename: Anna
authors.initials: A
authors.lastname: Miquel-Cases
authors.affiliation: Department of Molecular Pathology, Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, The Netherlands.
authors.forename: Philip C
authors.initials: PC
authors.lastname: Schouten
authors.affiliation: Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., P.O. Box 19024, Seattle, USA.
authors.forename: Lotte M G
authors.initials: LM
authors.lastname: Steuten
authors.affiliation: Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, The Netherlands; Department of Healthcare Technology and Services Research, University of Twente, Drienerlolaan 5, 7522 NB, Enschede, The Netherlands.
authors.forename: Valesca P
authors.initials: VP
authors.lastname: Retèl
authors.affiliation: Department of Molecular Pathology, Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, The Netherlands; Department of Pathology, Utrecht University Medical Center, Heidelberglaan 100, 3584CX Utrecht, The Netherlands; Division of Medical Oncology, Antoni van Leeuwenhoek Hospital - Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, The Netherlands.
authors.forename: Sabine C
authors.initials: SC
authors.lastname: Linn
authors.affiliation: Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Plesmanlaan 121, 1066CX Amsterdam, The Netherlands; Department of Healthcare Technology and Services Research, University of Twente, Drienerlolaan 5, 7522 NB, Enschede, The Netherlands. Electronic address: w.v.harten@nki.nl.
authors.forename: Wim H
authors.initials: WH
authors.lastname: van Harten
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis* / Q000378:metabolism; D001943:Breast Neoplasms / Q000737:chemistry / Q000175:diagnosis* / Q000378:metabolism; D006801:Humans; D011237:Predictive Value of Tests; D011379:Prognosis; D013673:Technology Assessment, Biomedical
chemical_list: D014408:Biomarkers, Tumor
keywords: Breast cancer; Health Technology Assessment; Predictive biomarkers