Early Phase Clinical Trial Network

1. Early Phase Clinical Trial Network UKMF Spring Day - 13 March 2013

2. Strategic The most pertinent clinical studies are identified based on Key Objectives and developed and prioritised by a Steering Group of myeloma specialists. Collaborative Stakeholders throughout the NHS, HTA, Patients and the Pharmaceutical Industry work together to implement the most effective clinical trial design and ensure effective adoption of data. Efficient Working as a network, coordinated via a central office with standard processes and procedures and working with NHS and industry stakeholders, the CTN aims to break down the barriers that delay research enabling studies to be delivered quickly and effectively. CTN Objectives

3. Leeds Clinical Trials Coordinating Office Bringing Stakeholders Together Clinical Experts

4. Leeds Clinical Trials Coordinating Office St James’s, Leeds City, Nottingham QE, Birmingham The Christie, Manchester RMH, London UCLH, London King’s, London Bart’s, London R Hallamshire Sheffield General H, Southampton Uni H Wales, Cardiff Uni Hospital, Oxford CTN Network Central Trial Office 8 Core Active Trial Centres 4 Additional Centres Expansion inc. Scotland & N Ireland

5. Other areas include: Improving the setting for adoption of non-commercial data Making best use of available resources, especially patients Promote novel clinical trial designs Supporting novel approaches to licensing e.g. adaptive licensing Developing novel drug life-cycle strategies Addressing health economic barriers Collaboration with pharmaceutical companies Development of “Pathways Model” to identify future optimum therapy CTN is part of a wider objective CTN trials are one part of a wider Myeloma UK objective to impact how clinical trial data is generated and adopted, to more effectively bring optimum treatments to patients.

6. Personalised Medicine Individualised treatment based on diagnostic biomarkers (i.e. genetic subgroups) Individualised treatment based on clinical presentation (clinical subgroups e.g. elderly/frail, high risk) Access to Treatments Promoting novel treatments Identifying evidence gaps for drugs currently in development that may prevent or delay them being approved by NICE and/or taken into UK practice. Planning studies around expected life-cycle of a drug in real world setting Strategic Approach to Selecting Trials CTN trials are identified and prioritised based on two objectives:

7. Current Portfolio of MUK Trials

8. CI and Co-Investigators

9. Biobanking Personalised Medicine Programme   Clinical Trial Network Myeloma Research Centres   Diagnostics Linking the CTN with Discovery Research

10. Why the MUK CTN important Patients are waiting… Myeloma patients need more effective treatments with less side-effects. In order to deliver this in the soonest possible time frame, we have set up the CTN to be more efficient and more effective. We must challenge the hurdles and the inefficiencies and strive for improvements in the system.

11. “Our Clinical Trial Network is a groundbreaking approach to clinical research in the UK. It is strategic, efficient and collaborative. Our model of engaging with stakeholders and breaking down barriers is not only changing the course of myeloma research, but could transform the way in which new treatments for other rare cancers are tested and accessed.” Eric Low OBE, CEO Myeloma UK