RDF19 Poster Detail
|DRU Cymru: How a Multidisciplinary Team Supports A Clinical Trial|
Introduction: The Diabetes Research Unit Cymru (DRU Cymru) facilitates and supports research into diabetes across Wales. The multidisciplinary team provides expertise in areas including study design and set-up, statistical support, public and patient involvement (PPI) and laboratory support. Colleagues in Cardiff University secured a grant for Wales’ first NIHR EME funded study, evaluating the effectiveness of a monoclonal antibody as a means of preserving insulin producing cells in young people with recent onset Type 1 diabetes (T1D).
Challenge Faced: Funding for the project could not be released until the study design and protocol were finalised.
Our Approach: DRU Cymru were contacted for guidance and support, and to provide protocol development in the following ways:
The DRU Cymru engagement team were instrumental in ensuring that people living with diabetes’ views were taken into account. Focus groups were held for young people with T1D and participant information sheets disseminated for review. The team supported a member of the DRU Cymru Public Reference Group in attending the Ethics Committee meeting, and provide continued support for the members who sit on the Trial Steering Committee.
A member of DRU Cymru is the designated statistician for the trial, providing full statistical support alongside the statistical analysis plan. Another member of the team was involved in producing the participant information sheets for the study, ensuring that they were age appropriate before being reviewed by young people with T1D.
Input from the DRU Cymru lab team has been integral to the design of the study protocol and site sampling manual. The lab team have advised on sample collection, storage and analysis processes, and are providing ongoing support in carrying out laboratory analysis on samples.
Conclusion: The work of the DRU Cymru allowed protocol development to commence prior to the designated clinical trials unit engaging with the study.
|Diabetes Research Unit Cymru|