Cost-effectiveness modelling for benefit-risk assessment


Catt, Heather Jane ORCID: 0000-0001-9515-7497 (2018) Cost-effectiveness modelling for benefit-risk assessment PhD thesis, University of Liverpool.

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Abstract

Introduction and aims: Benefit-risk assessment is important for summarising the effectiveness and safety profile of an intervention. Current methods for benefit-risk assessment are based upon flawed clinical trial data. For biosimilars, regulatory approval is given on the basis of extrapolated evidence assessed in qualitative benefit-risk frameworks, leading to uncertainties. This thesis aimed to investigate methods for assessing the benefit-risk balance of therapies, including identifying harms data and developing a quantitative framework for assessing whether the cost savings of biosimilars justify the increased uncertainties regarding efficacy and safety. Methods: This thesis reports a novel systematic review of the efficacy and harm outcomes reported in Crohn's disease (CD) randomised clinical trials (RCTs) to 2015. Extracted outcomes and adverse events data were categorised and the results benchmarked against a core outcome set (COS) for inflammatory bowel disease and the commonly used outcome measurement tools in CD RCTs. Summaries of Product Characteristics (SPCs) were investigated as a source of harms data with the use of standardised MedDRA (Medical Dictionary for Regulatory Activities) queries (SMQs). ... (continues)

Item Type: Thesis (PhD)
Divisions: Faculty of Health & Life Sciences > Inst. Life Courses & Medical Sciences > School of Medicine
Depositing User: Symplectic Admin
Date Deposited: 29 Apr 2019 14:08
Last Modified: 13 Apr 2025 07:03
DOI: 10.17638/03034908
Supervisors:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3034908
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