Work Package 2: Trial set up

Clinical Trial set up

Lead partner: University of Leeds (LEEDS)

The Clinical Trials Research Unit (CTRU), will coordinate WP2 supported by the co-sponsors KCL and UCD. The focus of WP2 is to set up and open the randomised double-blind trial for patients with breathlessness and advanced COPD or ILD across five European countries.

The set-up of the trial includes:
- writing the protocol, patient and carer information sheets
- gaining ethics and regulatory approvals,
- establishing key processes for conduct of the trial for when it opens to recruitment
- establishing key committees and organising initial meetings
- creating a database with electronic case report forms (eCRFs)
- creating the randomisation system and kit application for allocation of blinded drugs
- working with all members of the consortium to ensure the trial is feasible in all five countries

Once ethics and regulatory approvals have been received for the trial, site set-up will begin, and includes:
- Dissemination of trial documents to sites and translation where required
- Sites to obtain local ethical approvals where needed
- Site initiation and training in the trial procedures
- Coordination of shipment of drug to sites

WP2 requires input and engagement with all members of the consortium at different stages of set-up. Initially, a small group will work on producing a semi-final draft protocol and patient and carer information sheets. Once produced this will be disseminated to all other consortium members for their input and feedback. Particularly, to understand whether the proposed trial assessments and procedures are feasible to undertake in all countries. This feedback will inform the final versions of the documents to be submitted for ethics and regulatory approval.

Once ethical and regulatory approval has been obtained, all members will be involved in ensuring that their local sites are set up and ready to open to recruitment as soon as possible.