The use and reach of medical devices across all aspects of healthcare continue to grow, yet optimal design of clinical trials and clear pathways to safe and effective clinical use of devices are lacking. This project will carry out research that aims to improve the methods used in clinical studies of medical devices, with a focus on four areas: biostatistics, health economics, regulatory analyses and critical evaluation of clinical study design. In collaboration with the HRB Clinical Research Facility Galway (HRB CRFG), an exemplar framework for accelerating translation of medical device projects will be developed and used to review and provide structured support to all CÚRAM projects that are approaching clinical evaluations. The original research and structured support process will underpin training for CÚRAM researchers and wider dissemination activities.
Early engagement with trial methodology experts significantly enhances the safety and efficiency of medical device translation and can help to overcome specific barriers to conducting high quality device trials1. Pillar 4 has a core goal of supporting translation of medical devices towards the clinic via a structured translational review process for medical device projects. This will be underpinned by original research developing methodological expertise in four key supporting disciplines:
- Health economics: Knowing there remain unresolved issues in health economic methods for medical devices2, health economics methods for emerging medical devices will be developed and early health economics appraisals of early stage technologies carried out
- Biostatistics: In addition to direct project support, original research will be carried out to develop methodology around the generation of computationally efficient adaptive ranges development of open source online packages for the visualising statistical models as dynamic nomograms3
- Clinical trial design: Develop collaborations with the HRB Clinical Research Facility Galway (HRB CRFG) and explore and critique clinical trial methods for the assessment for medical device technologies
- Regulatory analyses: design and application of regulatory analyses of medical device technologies.
The ultimate objective will be successful translation of CÚRAM projects to active clinical studies, where appropriate with the HRB CRFG. The original research and structured support process will underpin training for CÚRAM researchers in the four supporting disciplines and wider dissemination activities.