Supporting research to make patients, and the NHS, better Update on Clinical Research Network Performance - time for further improvement Dr Jonathan Sheffield CEO

Top-level political support 6 Dec 2011: PM launches Strategy for UK Life-sciences at FT Global Pharma conference, backed by prospectus “We can be proud of our past - but we cannot be complacent about our future. The industry is changing, not just year by year, but month by month. We must ensure the UK stays ahead. Yes, we have got a leading science base, we’ve got four of the world’s top 10 universities and we have a National Health Service unlike any other. But these strengths alone are not enough to keep pace with what’s happening. We’ve got to change radically - the way we innovate, the way we collaborate, the way we open up the NHS.”

Key messages Build a life-sciences eco-system Attract, develop and reward the best talent Overcome barriers and create incentives for the promotion of healthcare innovation Tax changes to incentivize investment in R&D Funding to incentivize early ‑ stage investment Regulation: “tear down the regulatory barriers you face”

Central role of the NIHR NIHR incentives for efficiency in research initiation and delivery Publish clinical trial information against benchmarks Funding to NHS providers conditional on meeting a 70 day benchmark to recruit first patients for trials Health Research Authority - to combine and streamline approvals for health research Initiatives to promote and increase patient access to research NHS Constitution - consult on amending NHS Constitution so there is a default assumption (with opt out) that data can be used Clinical Practice Research Datalink - new secure data service Clinical Trials Gateway website and “app”

Innovation in the NHS David Nicholson report to the Government “Innovation Health and Wealth” “This requires a fundamental change to the way in which people currently work. At the heart of this is strong leadership – both clinical and managerial at all levels in the system. It will require all Leaders to identify and tackle the behaviours and cultures that stand in the way of innovation… We need to have the courage to make changes and be less risk adverse, we need to take a longer term view on investments and we need to ensure staff are supported to introduce new ideas and technologies.”

Key messages Reduce variation in the NHS, and drive greater compliance with NICE guidance Working with industry, develop and publish better innovation uptake metrics, and more accessible evidence and information about new ideas Improve arrangements for procurement in the NHS to drive up quality and value, and to make the NHS a better place to do business Bring about a major shift in culture within the NHS, and develop our people by ‘hard wiring’ innovation into training and education for managers and clinicians Every NHS Board should explicitly invest time, resource and effort in innovation. We will require the Chief Executive of every NHS commissioning organisation, including the NHS Commissioning Board, to take personal responsibility to ensure that arrangements are in place to champion research, innovation and adoption, and that the adoption and spread of proven innovation is central to their commissioning plans.

Clinical Research Network NHS engagementManaging performanceWorking smarter

Clinical Research Network NHS engagement League tables Incentives: HSJ Awards Patient publicity Structure changes

Clinical Research Network Performance management Objectives: time and target RAG reports Study milestone schedule

ObjectiveMeasure Baselin e TargetTimescale 1 Double the number of participants recruited into NIHR Portfolio studies Number of participants recruited in a reporting quarter into NIHR Portfolio studies 62,500125,000 4 years (31 March 2014) 2 Increase the proportion of studies in the NIHR Portfolio delivering to recruitment target and time target 2A: Proportion of commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at confirmed Network sites not available 80% 2 years (31 March 2012) 2B: Proportion of non-commercial studies managed by Registered CTUs achieving or surpassing their recruitment target during their planned recruitment period not available 80% 3 years (31 March 2013) 2C: Proportion of non-commercial studies not managed by Registered CTUs achieving or surpassing their recruitment target during their planned recruitment period not available 80% 5 years (31 March 2015) 3 Increase the percentage of commercial contract studies delivered through the NIHR Number of commercial contract studies on the NIHR Portfolio as a percentage of the total commercial MHRA CTA approvals for Phase II–IV studies, on an annual basis 38%60% 3 years (31 Dec 2012) 4 Reduce the time taken to achieve NHS permission through CSP for NIHR studies Proportion of studies obtaining NHS permission within 40 calendar days (from receipt of a valid complete application) 11%80% 3 years (31 March 2013) 5 Reduce the time taken to recruit first participant into NIHR Portfolio studies 5A: Proportion of commercial contract studies achieving first participant recruited within 30 calendar days of NHS Permission being issued, at confirmed Network sites not available 80% 2 years (31 March 2012) 5B: Proportion of non-commercial studies managed by Registered CTUs achieving first participant recruited within 30 calendar days of NHS Permission being issued not available 80% 3 years (31 March 2013) 5C: Proportion of non-commercial studies not managed by Registered CTUs achieving first participant recruited within 30 calendar days of NHS Permission being issued not available 80% 5 years (31 March 2015) 6 Increase the percentage of NHS Trusts participating in NIHR Portfolio studies Proportion of NHS Trusts recruiting each year into NIHR Portfolio studies 95%98% 3 years (31 March 2013)

High Level Objectives – summary on performance to date ObjectiveTarget2010/112011/12 Q1 1125,000141,175120,585 2A80%21%17% 2B80%100%50% 2C80%38%44% 360% 63% 480%8%11% 5A80%52%44% 5B80%22%17% 5C80%38%40% 698%97%

Non-Commercial Studies Managed by Registered CTUs, Recruitment to Time and Target

Proportion of Non-Commercial Studies by Registered CTUs, Calendar Days from NHS Permission to First Recruit Quarter 1 fell considerably short of this ultimate target, with 17% of relevant studies NHS Permission being issued the year 2010/11.

Clinical Research Network Working smarter LEAN programme (adoption) Costing templates & contracts Route-maps In-house company champions

Opportunities for Collaboration Lean Programme Data collection and upload Performance Management Commercial engagement

Links Life Sciences Strategy – strategy-for-uk-life-scienceshttp:// strategy-for-uk-life-sciences The “Prospectus” – Investing in UK Health and Life Sciences – BIS-Life-Sciences-Prospectus-BMK_Spreads.pdfhttp:// BIS-Life-Sciences-Prospectus-BMK_Spreads.pdf Innovation, Health and Wealth (Sir David Nicholson Report) – ublicationsPolicyAndGuidance/DH_131299http:// ublicationsPolicyAndGuidance/DH_ Public national league tables – research-zonehttp:// research-zone Clinical Research Network industry site –