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Stratified medicine: methods for evaluation of predictive biomarkers

Malottki, Kinga (2017)
Ph.D. thesis, University of Birmingham.

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Background: Stratified medicine was defined as the use of biomarkers to select patients more likely to respond to a treatment or experience an adverse event.
Alms: To investigate the hypothesis that there is a mismatch between the theoretical proposals and practice of predictive biomarker research, focusing on the clinical utility stage.
Methods: Methodological research was identified in a systematic review of frameworks for staged evaluation of predictive biomarkers. Actual research supporting 50 real cases identified in European Medicines Agency licensing was analysed. A case study of recent research into ERCC l in non-small cell lung cancer was undertaken. Existing discrepancies between the theory and practice were identified and possible reasons and consequences of these were discussed.
Findings: A mismatch between theory and practice was identified. It appeared to be a result of both the practice not following some theoretical requirements, and the underdevelopment of methodology for certain situations. Areas of clinical research with insufficient relevant methodology were identified.
Conclusions: The major research priorities identified in this thesis were development of a clear hierarchy of biomarker research designs and development of methodology related to the biomarker threshold.

Type of Work:Ph.D. thesis.
Supervisor(s):Billingham, Lucinda and Deeks, Jon
School/Faculty:Colleges (2008 onwards) > College of Medical & Dental Sciences
Department:Institute of Applied Health Research
Subjects:RA0421 Public health. Hygiene. Preventive Medicine
Institution:University of Birmingham
ID Code:7118
This unpublished thesis/dissertation is copyright of the author and/or third parties. The intellectual property rights of the author or third parties in respect of this work are as defined by The Copyright Designs and Patents Act 1988 or as modified by any successor legislation. Any use made of information contained in this thesis/dissertation must be in accordance with that legislation and must be properly acknowledged. Further distribution or reproduction in any format is prohibited without the permission of the copyright holder.
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