The UK-AILD Industry Programme represents a novel approach to industry collaboration in which a full work programme, adding substantial value to the overall programme, is fully funded by our industry partners. This programme has been designed and developed by the UK-AILD team in collaboration with investing partners to meet their specific needs. The industry programme will be delivered by the UK-AILD research team. It will play a key role translating the UK-AILD research programme into clinical practice. Key elements of the UK-AILD Industry Programme will include:
- Cohort Expansion & Data Capture: Industry funding will maintain recruitment to the UK-PBC, UK-AIH and UK-PSC cohorts as well as digital data capture from electronic medical records. It will also fund detailed, long-term symptom capture. Linking the programme to UK-AILD allows us to access NIHR funding for local recruitment activity. The link to NHS Digital will enable rapid and cost-effective clinical data capture (including all relevant outcome parameters). Participants are consented to be approached about future clinical trials and systems for patients outside trial centres to move through to trial centres are established and working. The UK-PBC, UK-AIH and UK-PSC cohorts will be used for the evaluation of new diagnostic markers generated in WS1 and WS2 and incorporated into novel trial models in WS3.
- Trials Platform: Utilising the UK-PBC, UK-AIH and UK-PSC cohort datasets as platforms to drive clinical trials and other clinical evaluation though targeted patient identification is an integral part of our vision and has been highly successful in UK-PBC (e.g. Nevens 2016, Hegade 2017). We propose that over the four year period of the programme, this model be expanded to cover all AILD; include the new trial models that will be developed by WS3, and support trials opened up by the New Taxonomy model. Industry funding will provide a full-time platform manager with associated data support. The manager will identify patients for recruitment to trials across UK-AILD, including post-licensing studies, as well as emerging trial indications. The targeted nature of recruitment using this model has proven highly successful in UK-PBC. Broader responsibilities of the post will include dissemination activities for the consortium.
- Disease Modelling: The datasets needed to support regulatory approval and then reimbursement are highly specific but uniquely valuable to industry. We therefore propose a comprehensive programme of health economic evaluation and detailed disease modelling across the full disease spectrum. Data capture will be through the extended UK-PBC, UK-AIH and UK-PSC cohorts, fully funded by industry.