1 Cancer Clinical Trials at SaTH  Helen Moore - Lead Research Nurse  9 th 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 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

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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 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)

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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

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41 Any questions?