Cancer Clinical Trials at SaTH

1. Cancer Clinical Trials at SaTH • Helen Moore - Lead Research Nurse • 9th JULY 2103

2. Year 2000 For every 1000 patients diagnosed with cancer in the UK, only 38 were entered into a well-designed peer-reviewed clinical study NCRI and NCRN were established

3. 2010/11 Recruitment:- • 45,783 cancer (& pre-malignant) patients entered into trials (19.8% of incident cases) 5 fold • For every 1000 patients diagnosed with cancer in the UK, 198 entered a well designed trials

4. Recruitment Targets:- • 399 cancer patients 2012-2013 • 172 into randomised controlled trials • 1600 in total (cancer and non-cancer)

5. Why Do We Need Clinical Research?

6. Society needs clinical research………….. • Identify unnecessary/ineffective treatments to better utilise resources • Develop targeted screening and treatment programmes from pathological and genetics studies • Healthier population • Attract/retain pharmaceutical industry in the UK

7. Patients need clinical research ……… • Evidence base for best treatment • Reduce deaths • Increase disease-free survival • Improve quality of life/relieve symptoms • Enhance quality of care • More in-depth investigations • Patient choice – should be offered available trial • Patients in trials do better even on standard treatment. (Stiller 1994)

8. SaTH needs clinical research ….. • Supports Trust objectives • Reduces drug budget • Need trials for Foundation Status • Attracts patients & top class staff • Retention of Services and status • Provides training, education and support

9. Staff need clinical research … • Opportunity to be involved in ‘newer’ drugs/techniques • Support of Clinical Trial staff • Adhere to protocols – safety • Interesting………..stimulating…..challenging • Educational opportunities

11. Ethical Principles • Declaration of Helsinki 1964 (2000) • MREC & R&D approval • Based on sound scientific principles • Patient’s rights, health and wellbeing paramount • Ethically conducted • Appropriate resources and skills

12. What is Good Clinical Practice (GCP)? A standard for Clinical Trials Ensure the rights, safety and well-being of trial subjects Ensure the integrity of clinical data GCP concerns everyone working on any aspect of clinical research!

13. Required to inform study centre within 24hrs of knowing if a trial patient has been admitted • Serious Adverse Event (SAE) • Serious Unexpected Suspected Adverse Reaction (SUSAR) • MHRA Inspection

14. Phases of Trials • Phase I • small numbers • from test tube to patient • maximum tolerated dose (MTD) • advanced cancer • not a specific cancer • pharmakokinetics • Phase II • effectiveness of treatment • larger numbers • optimal dose • side-effect profile • anti-emetic study

15. Phase III • test new drug against standard treatment • larger numbers (1000’s) • RCTs (randomised controlled trials) • Quality Of Life component • Health Economics - costings

16. Different Types of Trials Randomised Controlled Trials (RCTs) • Comparing new treatment (study arm) with standard treatment (control arm) -5/6 arms • Treatment randomly allocated • Each group has a similar mix of patients (age, stage of disease, sex) • Reduce bias • Most reliable results

17. Placebo-Controlled Trials • Control group receive inactive treatment • Where there is no standard to compare with • Can unblind if required • COG trial • Cancer of the oesophagus -Gefitinib vs placebo • REACT trial • Celecoxib

18. Non-interventional trials • Tissue samples • Blood samples • Better understanding of cancer • Improved screening programmes

19. Patient Preference Trials • PISCES

20. Surveillance Trials • FACS • Dept of Health

21. Cancer Clinical Trials • 20 open currently recruiting studies • 30 closed studies with patients in follow-up • More than 2000 patients recruited into cancer trials over last 15yrs @ SaTH

22. Cancer Clinical Trials at SaTH • Broad Portfolio • Chemotherapy • Radiotherapy • Targeted Therapies • Supportive therapies (anti-emetics/bisphosphonates) • Genetics/Epidemiology • Surveillance • Patient Preference

23. Breast Trials PERSEPHONE STUDY - (6mths vs 12mths Herceptin) SafeHer - subcutaneous delivery of Herceptin T-DM1 - novel antibody drug conjugate FastForward – 15# vs 5# radiotherapy SEARCH – genetic study in male breast cancer

24. Colorectal Trials Short Course Oncology Therapy study (SCOT) – 4 cycles vs 8 cycles chemotherapy NSCCG – patients with family history of colorectal cancer – genetics study

25. Urology Trials STAMPEDE – Androgen-Deprivation Therapy alone or with Abiraterone or radiotherapy to the prostate Radicals - Radiotherapy and Androgen Deprivation in combination after a radical prostatectomy POUT – role of chemotherapy after a radical nephro-uretectomy PROMPTS– whether a pre-emptive MRI spine may be beneficial in preventing spinal cord compression in patients with spinal metastases Familial Prostate – genetics study of men diagnosed under 60yrs

26. Gynaecology Trials ICON8 – role of fractionated chemotherapy in women with newly diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer SEARCH – genetics study looking at ovarian and endometrial cancers PORTEC 3 – role of chemotherapy in High Risk and Advanced Stage Endometrial Carcinoma

27. Lung Trials ET – role of ERCC1 in non-small cell lung cancer treated with chemotherapy

28. Pancreatic Trials ESPAC4 – addition of Capecitabine chemotherapy

29. Haematology Trials NSHLG – genetics study

30. Head and Neck Trials H&N5000 – genetics study

31. Dermatology Trials SEARCH – genetics of melanoma

32. How do we decide which studies to do at SaTH? • UKCRN Portfolio • Academic links • Pharmaceutical links • Attend national meetings • Attend Network meetings • Consultants/SpRs

33. How do we identify patients? • Screen every oncology clinic • Attend MDM • Attend non-oncology clinics if required • Check basic eligibility • Starter pack • Attend consultation • Contact patient after consultation

34. Patients should always be offered a trial if eligible • Better outcomes for patients in clinical trials, even on standard treatment (Stiller 1994)

36. Reduced Treatments • SCOT (4# vs 8#) • Persephone (6mths vs 12mths) • 142 saved CDC slots 2011 – 2012 • Cost savings • Free drugs • Free anti-emetics and chemotherapy in ET (£11,000)

37. IPSOS MORI poll in June 2011 • 97% of the public believe it’s important for the NHS to support research into new treatments • 93% want their local NHS to be encouraged or required to support research • 72% would like to be offered opportunities to be involved in trials of new medicines or treatments, if they suffered from a health condition that affects their day-to-day

38. Mystery shopper campaign Results showed that: • 91% of the NHS sites visited did not have information on clinical research opportunities in the obvious places for patients • Only 34% of the sites visited had information about clinical research on their websites that was useful to patients • 46% of reception desks told the mystery shopper that they did not do research, or failed to offer any suggestions about what to do next • More than half of the sites (55%) were unable to provide useful information about clinical research through their Patient Advice and Liaison Service

39. International Clinical Trials Day • Radio Shropshire • PPI • R&D Committee • Raising profile in Trust

41. Any questions?