Clinical trials help us understand what treatments should be recommended and available in the National Health Services. At the centre of clinical trials research and results’ interpretation is a (target) difference. Target differences are the difference between a treatment and a control that will convince stakeholders (policy makers, clinicians, and patients) that one is better (superiority trials) or good enough (non-inferiority trials) compared with the other. Only 5% of pragmatic trials report to consult patients or other stakeholders about the target difference. In non-inferiority trials, the difference selected has been shown to be extremely poor with limited patient input, leading to the frequent recommendation of inappropriate treatments.
The PINpoINT project builds from the PoINT programme findings and aims to identify, adapt and test methods and tools to ensure patient important differences are considered at the trial design stage.
Ultimately, this will improve the transparency and rationale to select target differences in trials, and ensure trials are able (powered) to look for important differences. The project will combine participatory approaches, such as co-design and group concept modelling, with medical statistics to achieve this. It includes three work packages: a review of opinion seeking methods to determine target differences from patients and the public; co-developing tools to enable meaningful patient and public involvement in determining a target difference at the design stage of trials; and testing and evaluating the process in real-life case studies.
The project will generate guidelines, and case studies, that will enable patient and public involvement in target differences in trials.
Chief Investigator
Dr Beatriz Goulao
Funder
Better methods, better research panel from the Medical Research Coucil
Advisory group and project partners
Lynn Laidlaw, Irene Soulsby, Derek Stewart (Public partners)
Marion Campbell, Katie Gillies, Craig Ramsay (University of Aberdeen, Project mentors)
Gordon Guyatt, Tahira Devji (Mcmaster University)
Andrew Cook (University of Southampton)
Sophie Staniszewska (University of Warwick)
Kerry Hood (University of Cardiff)
Contacts
- Beatriz Goulao; beatriz.goulao@abdn.ac.uk