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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
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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
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Recruitment Targets:-
399 cancer patients 2012-2013 172 into randomised controlled trials
1600 in total (cancer and non-cancer)
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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
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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)
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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
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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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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
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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!
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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
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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
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Phase III
test new drug against standard treatment larger numbers (1000’s) RCTs (randomised controlled trials) Quality Of Life component Health Economics - costings
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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
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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
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Non-interventional trials Tissue samples Blood samples Better understanding of cancer Improved screening programmes
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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
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Cancer Clinical Trials at SaTH Broad Portfolio
Chemotherapy
Radiotherapy
Targeted Therapies
Supportive therapies (anti-emetics/bisphosphonates)
Genetics/Epidemiology
Surveillance
Patient Preference
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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
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Colorectal Trials
Short Course Oncology Therapy study (SCOT) – 4 cycles vs 8 cycles chemotherapy
NSCCG – patients with family history of colorectal cancer – genetics study
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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
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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
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How do we decide which studies to do at SaTH?
UKCRN Portfolio Academic links Pharmaceutical links Attend national meetings Attend Network meetings Consultants/SpRs
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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
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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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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)
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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
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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