The trial that goes wrong : application of the model of organizational accidents to understanding the failure of clinical trials : case study of a UK public sector-funded clinical trial of an investigational medicinal product

Parsons, Sunaina

Medicine
2019

Thesis or dissertation


Rights
© 2019 Sunaina Parsons. All rights reserved. No part of this publication may be reproduced without the written permission of the copyright holder.
Abstract

Successful clinical trials are essential to guide clinical practice, however, there is significant risk involved in ensuring the delivery of a successful clinical trial. The most common reason for randomized controlled trial failure in the UK is the inability to recruit in an adequate and timely manner. Trials that end prematurely without reaching their intended goals raise considerable ethical and financial concerns. This study uses a single multisite randomized controlled clinical trial of an investigational medical product, which was closed early, as a case study setting to explore the circumstances around trial failure.

Aims were to explore the reasons for trial failure, and in the context of the literature, learn lessons that could help to reduce the risk of failure in future studies.

A systematic review of the literature was undertaken in order to examine causes of poor trial recruitment, and to validate the methods used as part of the assessment of the case study trial.

I explored experiences and perceptions of individuals from stakeholder groups about the failure of this trial, analysed the data and mapped the results to the Model of Organisational Accidents and the Team error taxonomy. This is the first application of Reason’s model of organizational accidents within a trial management context A qualitative design was used, using semi structured interviews with a purposive sample of individuals representative across the trial stakeholder groups. Interviews were conducted, fully recorded and transcribed, then analysed using frameworks derived from the risk management literature to provide a descriptive framework for the context of the case study, and then a second body of theory was used to provide an explanatory framework in order to see links between the actions of individuals, groups and situations in order to better understand the reasons why this trial failed.

The case study trial had shortcomings in design, had setbacks in the planning phase, where there were significant delays in appointing staff and commissioning essential components of the trial. The study fell behind time, there was budgetary overspend and issues throughout the trial relating to poor communication between stakeholder groups.

All of the mistakes and lapses that occurred over the course of the study were avoidable, but the combination of inadequate experience, resources and motivational factors led to an atmosphere where mistakes were not identified or corrected due to factors relating to institutional hierarchy.

The case study showed how fallible decisions at a senior management level allowed line management deficiencies within a project team and an environment where mistakes, violations and unsafe acts could occur. The analysis shows how the whole organizational system contributes to causal pathways associated with project failure, taking account of the culture of an organization and issues such as ‘excessive authority gradient’.

The study suggests the need to improve monitoring of clinical trials and their progress, and aiming future research towards how funders assess investigators and host institution infrastructure as fit to lead research projects. The future development of a robust risk assessment tool that can be applied to new research projects may be useful in preventing a similar situation in the future.

Publisher
Hull York Medical School, The University of Hull and The University of York
Qualification level
Doctoral
Qualification name
MD
Language
English
Extent
3 MB
Identifier
hull:17720
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