Clinical Research and the NHS … ….and economics?

1. Clinical Research and the NHS…….and economics? Joanna Coast PERCAT Masterclass, April 2013

2. Clinical Research and the NHS…….and Economics? Joanna Coast PERCAT Masterclass, April 2013

3. Outline • Why economics? • Health, economics & clinical research • A case study of governance for economics research

4. Why economics?

5. THE TIMES February 13, 2007 New cancer drug to save a thousand lives a year Nigel Hawkes, Health Editor More than a thousand women a year will survive breast cancer thanks to a type of drug that improves survival rates by 17 per cent, new research shows today. A study of 4,742 post-menopausal women found that switching from the present gold-standard breast cancer treatment tamoxifen to the new drug exemestane after two or three years resulted in thedramatic fall in death rates.

6. The Telegraph May 2010 New drug reverses even 'untreatable' cancers • Cancer patients may be offered new hope in the form of a harmless virus which can reverse even apparently untreatable forms of the disease when injected into tumours. • Tumours shrank or stopped growing in every patient who underwent radiotherapy coupled with a new drug, Reolysin, which contains particles of reovirus.

7. The Telegraph 3 Jan 2011 IVF women given fresh hope by new fertility treatment Women who have endured repeated IVF failures have been given fresh hope by a new fertility treatment that studies indicate can increase success rates fivefold.

8. 1 course of IVF costs £2700

9. = 1/3 cochlear implant 1 course of IVF costs £2700

10. = 1/3 cochlear implant 1 course of IVF costs £2700 = 1 heart bypass

11. = 3 cataract removals = 1/3 cochlear implant 1 course of IVF costs £2700 = 1 heart bypass

12. = 11 cataract removals = 1/3 cochlear implant 1 course of IVF = 150 MMR vaccinations costs £2700 = 1 heart bypass

13. “Economics is usually a rather doom-laden subject, and in this respect is linked indirectly with medicine through the observation that the only two things in life that are certain are death and taxes.” Alan Williams

14. Health, economics & clinical research

15. Which interventions give the greatest benefit for the resources available?

18. $ £ €

19. $ £ €

20. Identifying, measuring & valuing costs • Measure in terms of physical resources • Value using Unit costs N=? N=? N=? N=? N=? N=? N=?

21. Identifying, measuring & valuing outcome • NICE (National Institute for Health and Care Excellence) recommends measures that: • combine length and quality of life • have meaningful values • have general population values • Called QALYs (Quality-Adjusted Life-Years) N=? N=? N=?

22. Economic evaluation • Research with clinical teams • Often alongside RCTs • Multidisciplinary • Recent trial on PhysioDirect included • GPs • Physiotherapists • Qualitative researchers • Statisticians • Health economists

23. A case study of governance for economics research

24. Simple design • New measure – ICECAP-SCM • People (and/or proxies) at end of life to complete the measure • Tape record while they complete • Transcribe tape recording • Analyse transcripts

25. Challenging process (1) • Sponsorship • Through University • Sub-contracting • To hospice for assistance with recruitment • University contract services & Marie-Curie contract services

26. Challenging process (2) • Ethics • NRES generic form • Site specific form? • Not clear whether hospices are NHS or non-NHS • Complexities around people unable to consent for themselves • Importance of having patient/carer input into documentation

27. Challenging process (2) • Governance • Not clear whether NHS R&D Governance required • Eventually decided yes… • … but also no! • R&D forms required • But ‘Research passport’ issues left to hospice • CRB checks • Immunisations • CV & training checks • Hospice governance & permissions also required

28. A final word from Alan Williams “We are not defeatist prophets of gloom and doom, obsessed with death and taxes, but active workers for improvement, concerned to improve the quality of people’s lives to the maximum feasible extent. That is why I think that health economics is the cheerful face of the dismal science.”