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NIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO [email protected] RD Forum 15/05/2017

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Page 1: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

NIHR Clinical Research Network:Adding Value Together

Dr Jonathan [email protected]

RD Forum 15/05/2017

Page 2: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

National Institute for Health Research:integrated health-research system

> £0.5 billion p.a. investment in relevant infrastructure to

support clinical research at all points in development pipeline

Invention Evaluation Adoption

Early-phase clinical Research Late-phase clinical Research

NIHR Biomedical Research Centres

NIHR Clinical Research Facilities

Experimental Cancer Medicine Centre

Health Technology Cooperatives

Diagnostic Evidence Cooperatives

NIHR Clinical Research Network

Collaboration for Leadership in Applied Health Research and Care

Page 3: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

• Research active engaged clinicians across all 30 specialty areas

• Detailed understanding of care pathways

• 15 Local Clinical Research Networks (LCRNs)

• Allows flexible deployment of resources

• Links with rest of UK

One national network

Page 4: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Our vital statistics

Clinical Research Network

Page 5: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

The evidence: recruitment

Number of participants into all NIHR CRN Portfolio studies -commercial (red) and non commercial (blue)

• 3.5 million people recruited into all studies over the last 6 years

2016/17 est. 666,000

Page 6: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

The evidence: increased volume

Number of new commercial studies added to the NIHR CRN Portfolio

2016/17 est. 729

Page 7: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

UK v world

Clinical Research Network

Commercial, no phase selected

Source: https://clinicaltrials.gov/

Top 10 countries

United States 3404Germany 912United Kingdom 855Canada 709France 673Spain 617Italy 495Belgium 463Korea 445Netherlands 401

Page 8: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

UK v Europe

Clinical Research Network

Commercial, no phase selected

Source: https://clinicaltrials.gov/

Top 10 countries

Germany 912United Kingdom 855France 673Spain 617Italy 495Belgium 463Netherlands 401Poland 344Hungary 240Czech Republic 237

Page 9: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

Set Up: UK v the world

Data source: Global CRO 2

• Start point: Site selection visit• End point: Site initiation visit

Start-up (SSV-SIV) (Median)

Region/Country Days No of studiesJapan 92 568

USA/Canada 135 1893United Kingdom 179 204

Germany 245 172Asia Pacific 250 579

Italy 267 199France 271 170Poland 280 142

Page 10: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

The evidence: time and target

Percentage of NIHR CRN commercial studies recruiting to time and target

Recruiting less than 100% of target or exceeding 100% of planned recruitment period

Recruiting 100% of target within 100% of planned recruitment period

2016/17 est. 73%

Page 11: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

Managing performance with quality

• A research-ready workforce 10,000+ GCP-trained research staff embedded in the NHS to support investigators with patient identification, recruitment, clinical delivery

• ICH GCP trainingFree to any staff working on NIHR CRN clinical trials

Supported by MHRA

Added to the list of GCP programs mutually recognised by TransCelerate

Page 12: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Insert your organisation name here

KPMG Impact & Value Assessment

The report considers:

• Wider economic impact of clinical research activity supported by the CRN

• monetary benefits to the NHS

• value added by the CRN’s support of a national portfolio

Page 13: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

KPMG estimates:

In financial year (FY) 2014/15, CRN supported clinical research activity generated:

Almost 39,500 jobs

£2.4 billion of gross value added

(GVA)

Page 14: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

Commercial research:Monetary benefits to NHS Trusts

Clinical Research Network

KPMG found:

• estimated totals • £176 million of commercial income

and • £16 million of pharmaceutical cost

savings

• average pharmaceutical cost saving of £5,250 per patient, where a trial drug replaced the standard of care treatment

• average £6,658 in revenue from sponsor companies

Total £192 million

Page 15: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

Research activity and improved patient survival

Page 16: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

Research activity and improved patient survival

• There was nearly a four per cent increase in the five-year survival rate for those treated in research-active hospitals which was highly significant (p<10-19; 5-year difference: 3.8% ).

• Improvement precedes and increases with the level and years of sustained participation.

• Important message for the NHS

Page 17: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

Supporting the future

Page 18: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

Precision or Personalized Medicine?

Page 19: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

• An integrated trial programme of parallel, molecularly stratified randomised comparisons for patients with advanced or metastatic colorectal cancer

• ‘window of opportunity’ to test clinical efficacy of targeted novel agent(s) after 1st line chemotherapy but beforeresistance to standard agents occurs

• Multi arm multi stage (MAMs) design - cost and time efficient

• Adaptable to new biomarker and clinical data as the trial proceeds

Precision Medicine - FOCUS4

Page 20: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

Personalized Medicine

https://www.youtube.com/watch?v=RRy_73ivcms

How many mechanics to change a wheel?

20

Page 21: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Networkh 21

Page 22: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

Future predictions

Gartner Predictions from 2017:

• By 2021, 20% of all activities in which an individual engages will involve at least one of the Top Seven Digital Giants– Alibaba Group– Bai– Tencent– Facebook– Amazon– Google– Apple

Page 23: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

Page 24: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

Personalised Health and Care 2020

Using Data and Technology to Transform Outcomes for Patients and Citizens:‘bring forward life-saving treatments and support innovation and growth’ – make England a leading digital health economy in the world and develop new resources to support research and maximise the benefits of new medicines and treatments, particularly in light of breakthroughs in genomic science to combat long-term conditions including cancer, mental health services and tackling infectious diseases.’•

Page 25: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

Join Dementia Research (JDR)

What is ‘Join dementia research’?

…. a nationwide online and telephone service that will help you find, discover and take part in vital dementia research studies

Page 26: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017
Page 27: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

“Real world” studies

h 27

Page 28: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

What do we need to do?

• Continue to improve and modify current processes

• Absolute partnership and collaboration

• Develop a digital strategy that makes research democratic

• Be prepared to take risk and disrupt current processes

• Involve patients in all these steps

Page 29: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

ICTD 2017 – get involved

NIHR 2017 International Clinical Trials Day (ICTD) research awareness campaign. Multiple ways to get involved at:

www.iamresearch.co.ukSomething we can all do now (if you’ve not done so already):

I Am Research Thunderclap - Join hundreds of other people and org’s sending the same message/post on Twitter/Facebook on 20 May at 12pm.

• Message sent automatically through your chosen social media account• Takes 30 secs to sign up - message promotes benefits of health and social

care research – join the thunder and get our voice heard!• Find out more at www.iamresearch.co.uk

Page 30: NIHR Clinical Research Network: Adding Value · PDF fileNIHR Clinical Research Network: Adding Value Together Dr Jonathan Sheffield CEO Jonathan.sheffield@nihr.ac.uk RD Forum 15/05/2017

Clinical Research Network

Networking locally to deliver globally

Contact the study support team at:

Email: [email protected]: +44 (0)113 34 34 555

Web: www.supportmystudy.nihr.ac.uk