1. How Clinical Cancer Trials Work in the UK Henry Kitchener, University of Manchester ANZGOG March 2013

2. Background  The NHS has a vast budget which requires evidence to define standards of care  The UK government understands this and is really committed to evidence based medicine  NICE defines standards of care with national guidance  This may be misconstrued as ”rationalising” but funding does require evidence of cost effectiveness.

3. Background  UK has a prominent history of clinical trials.  The public have a supportive view and understand the importance of trials.  There is adequate funding for trials.  There is enthusiasm amongst clinical investigators.  UK is therefore fertile soil for clinical trials.

4. Source of funding gynaecological cancer trials  CRUK  Funds Phase II and III trials through CTAAC.  20-25 new trials per year, across all cancer.  Focus is on survival outcomes.  NIHR HTA  Funds mainly Phase III trials across all of clinical medicine.  For cancer, focuses more on screening, quality of life, and prevention outcomes.  Commercial  Pharma sponsored studies and investigator led studies which a public body sponsors.

5. Funding model  Direct costs; salaries & oncosts  Indirect costs; admin & estates charges  Consumables; essential materials  Service support; additional investigations over standard of care  “Excess treatment” costs; cost of the intervention if it were adopted after the trial. This also applies to screening.

6. Funding model CharitiesTreasuryPharmaHealth “Authoritiy” Direct costs  Indirect costs  Consumables  Service support  (sponsored)Local Research Network Excess treatment costs 

7. Trial funding  Trials funded by the Treasury, the AMRC and “approved” investigator led Pharma trials are put on the National Portfolio.  National Portfolio trials qualify for support of research nurses. Funded through NCRN  Trust obtain public R&D funding for recruiting to clinical trials.

8. Trial costs  “Full economic costs” are part of the funding model of Universities  CRUK up to £100K/year to cover direct costs  NIHR HTA typically fund more complex trials which with FEC are £300-500K per year.

9. Clinical trials in the UK  UK “suffers” from heavy regulation and hurdles to overcome.  Despite this trials are seen as the most direct route to influencing standard of care.  Can underpin a successful career  “Impact” is increasingly the gold standard for effective R&D but  Trials do require considerable determination and motivation.

10. InterGroup Trials  Funders do understand the need for international participation.  The GCIG is respected beyond the Gynae Cancer community.  Funding is available for trials led from ANZGOG as well as from the UK; recent examples  PARAGON (ANZGOG)  IP Chemotherapy (NCIC)

11. The Future  Need to reduce bureaucracy  Targeted therapy  Biomarker led interventions (personalised medicine)  More complex trial design  More expensive trials  Molecular pathology (GCLP)  Biobanking