Clinical Research Infrastructure and Trials Platform

The opportunity is to enable the Clinical Trials Units at UoW and UoB to increase the region's market share in clinical trials. The UK Science base is recognised as internationally excellent and the ; j translation of this excellence into improvements in clinical practice is essential to ensure the continued l delivery of UK health and economic benefits, however this process is limited by a number of factors, including: Current low levels of business-knowledge base collaboration: There is a need for more efficient knowledge transfer between the knowledge base and industry. Businesses recognise the value of working with Universities, however there can be confusion about how to access the required expertise. There is a clear need to encourage greater R&D investment from industry in the region as the West Midlands currently has lower levels of private sector investment in R&D than any other English Region 1• However, as a result of this project there will be a new, single, web portal and infrastructure to sustain more efficient R&D processes and this will be very attractive to industry. This will considerably speed the time for trial set-up, recruitment and delivery. Requirement for additional space: Both Warwick and Birmingham need more space to accommodate the extra staff who will undertake the high volume of proposed Clinical Trials activity. New and refurbished buildings are needed to increase our Trials work in the most cost-effective and efficient manner. Unification of three existing internationally-renowned Trials Units at UoB (the Cancer Research UK Clinical Trials Unit (CRUK CTU), the Birmingham Clinical Trials Unit (BCTU) and the existing facilities and personnel in the Primary Care Unit at UoB) will provide increased efficiency and output. The risk of 'knowledge drain' from the region: As highlighted in the Cooksey Review and the Lambert Review (also referred to in Section 3.3) the region has world-class strengths in biomedical research. However, without further investment this leadership position is in danger of being lost to other key UK and international centres with the loss of key research jobs, skilled graduates and opportunities to commercialise the research outputs. The region has the highest net outflow of PhDs of any English region. As a result of this project, by having more space we will be able to employ more people and help to stop the drain. Requirement for the Outreach bus: The ethnically diverse population within the West Midlands is a major benefit for Clinical Trials in the region and makes our facilities especially attractive to business. However, accessing this population for clinical research can be challenging. Creating a fully functional mobile clinical research facility (an outreach bus to go to GP surgeries and smaller hospitals) allows us to take research out into the community and provides a highly effective method of patient and volunteer recruitment. Patient and healthy volunteers for clinical research programmes will be recruited through GP surgeries and hospitals where facilities for clinical research do not exist. A key issue in all clinical research programmes is the recruitment of subjects who are representative of the surrounding community. An additional element is that some of our research programmes tackle human diseases that are primarily managed in a community rather than in a hospital setting. The concept of an outreach bus is to reach under-represented communities. Such an approach has been tried and tested and is proven to be effective in providing healthcare to under-represented groups. This is consistent with current government initiatives such as 'Research for Patient Benefit', a major Department of Health funding priority. Please see Appendix E for additional information on the Outreach Bus. Requirement for state of the art analytical equipment: Early stage research forms the basis of discovery that underpins subsequent Clinical Trials, leading to benefits to patients from more costeffective and cost-efficient treatments. This early stage or 'basic' research entails studying the molecular mechanisms underlying human disease, which in turn requires new equipment so that cellular and molecular events can be studied quickly and accurately. This is an ever-evolving field and investment is required to enable the institutions to compete with similar organisations and attract investment from research funders and commercial companies.