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

10

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)

35

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

40

41

Any questions?