The value of clinical trials : a New Zealand case study

Objective: The research question addressed in this thesis is - 'What is the value of conducting sponsored clinical trials in a publicly funded New Zealand hospital?' Methods: The research design is a simultaneous parallel mixed method design that incorporates two strands (1) A quantitative analysis of economic outcomes and (2) a qualitative analysis of perceived value. In the first strand, quantitative methods draw on the data relating to two sponsored clinical trials. The data include Ministry of Health data, The Centre for Clinical Research and Effective Practice (CCRep) profit and loss statements, Counties Manukau District Health Board (CMDHB) annual reports and Chronic Care Management (CCM) data and results from a health outcome co-study. The second strand uses qualitative methods to explore the benefits and costs of sponsored clinical trials perceived by stakeholders. The study gathers data using focus groups, interviews and surveys and adopts a qualitative descriptive approach followed by a phenomenographical analysis. Results: The economics outcomes strand finds that CCRep, CMDHB and New Zealand society all derive financial benefits from these trials. The magnitude of the economic benefits differs depending on the perspective taken. Both CCRep and CMDHB have benefits that are positive but small. The largest and potentially the most controversial benefit is a benefit to New Zealand society of over 373,000 dollars. The qualitative results suggest that the benefits of conducting sponsored clinical trials within a publicly funded New Zealand hospital outweigh the costs in respect of all stakeholder groups. The results allow classification of the stakeholders into three layers: societal; where benefits and costs are filtered by political and social opinions; organisational; where benefits and costs are seen in terms of their influence on organisational functions and personal; where benefits and costs are seen as contributing to the psycho-social, cognitive, physical and behavioural needs of individuals. Conclusion: Public bodies must be mindful of the wider economic, social and cultural implications of their activities. This study demonstrates the value created from conducting clinical trials. The adoption of qualitative and quantitative methods to measure this value produces a more rounded analysis than would be the product of either approach on its own.