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How are progression decisions made following external randomised pilot trials? A qualitative interview study and
Katie Mellor1, Susan J Dutton2, Sally Hopewell2
1Oxford Clinical Trials Research Unit/Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, UK. katie.mellor@ndorms.ox.ac.uk.
Progression criteria for external pilot trials are not a one-size-fits-all solution. Stakeholder experiences reveal a complex decision-making process influenced by various factors beyond predefined criteria, impacting future research progression.
Area of Science:
- Clinical Trials Methodology
- Health Services Research
- Research Evaluation
Background:
- External pilot trials are crucial for informing definitive randomized trials.
- Progression criteria are often used to guide decisions on trial continuation.
- Understanding stakeholder perspectives on these decisions is essential.
Purpose of the Study:
- To explore stakeholder experiences with progression decisions after external pilot trials.
- To understand how progression criteria influence these decisions.
Main Methods:
- 35 semi-structured interviews with pilot trial team members (chief investigators, managers, statisticians, PPI representatives).
- Thematic analysis using the framework method.
- Focus on experiences with progression decisions and the role of criteria.
Main Results:
- Six themes emerged, including varied opinions on progression criteria value and development.
- Personal interests, stakeholder engagement, and lessons learned impact criteria applicability.
- Progression decisions involve multiple factors beyond criteria, such as efficacy signals and team continuity.
- 'A one-size approach to progression does not fit all' encapsulates the nuanced decision-making.
Conclusions:
- Progression criteria are just one element in deciding pilot trial feasibility.
- A flexible, tailored approach to progression is necessary.
- Pilot trial progression is not guaranteed, even if deemed feasible, potentially leading to research waste.
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