Work Package 2: Trial set up

Clinical Trial set up

Lead partner: University of Leeds (LEEDS)

The Clinical Trials Research Unit (CTRU), has coordinated WP2 supported by the co-sponsors KCL and UCD. WP2 focussed on the set-up and opening of the randomised double-blind trial for patients with breathlessness and advanced COPD or ILD across five European countries. This has included:

- finalising the protocol and all participant facing materials (information sheets, consents forms, questionnaires)
- dissemination of trial documents to sites and co-ordinating translation into local languages
- gaining ethical and regulatory approvals
- establishing key processes for the conduct of the trial including the establishment of independent oversight committees
- creating the trial database, randomisation and kit-allocation systems
- providing site initiation and training in trial procedures

This has been a truly collaborative work package requiring input and engagement with all members of the consortium at different stages of set-up.