Transcript CHEMOTHERAPY DAY CENTRE UPDATE What`s happening in Clinical Trials

Cancer Clinical Trials at
SaTH
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Helen Moore - Lead Research Nurse
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9th JULY 2103
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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
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For every 1000 patients diagnosed with cancer
in the UK, 198 entered a well designed trials
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Recruitment Targets:-
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399 cancer patients 2012-2013
172 into randomised controlled trials
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1600 in total (cancer and non-cancer)
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Why Do We Need Clinical Research?
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Society needs clinical research…………..
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Identify unnecessary/ineffective treatments to better utilise resources
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Develop targeted screening and treatment programmes from
pathological and genetics studies
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Healthier population
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Attract/retain pharmaceutical industry in the UK
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Patients need clinical research ………
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Evidence base for best treatment
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Reduce deaths
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Increase disease-free survival
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Improve quality of life/relieve symptoms
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Enhance quality of care
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More in-depth investigations
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Patient choice – should be offered available trial
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Patients in trials do better even on standard treatment. (Stiller 1994)
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SaTH needs clinical research …..
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Supports Trust objectives
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Reduces drug budget
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Need trials for Foundation Status
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Attracts patients & top class staff
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Retention of Services and status
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Provides training, education and support
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Staff need clinical research …
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Opportunity to be involved in ‘newer’
drugs/techniques
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Support of Clinical Trial staff
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Adhere to protocols – safety
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Interesting………..stimulating…..challenging
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Educational opportunities
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Ethical Principles
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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
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Phase I
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small numbers
from test tube to patient
maximum tolerated dose (MTD)
advanced cancer
not a specific cancer
pharmakokinetics
Phase II
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effectiveness of treatment
larger numbers
optimal dose
side-effect profile
anti-emetic study
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 Phase
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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)
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Comparing new treatment (study arm) with standard treatment (control
arm) -5/6 arms
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Treatment randomly allocated
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Each group has a similar mix of patients (age, stage of disease, sex)
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Reduce bias
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Most reliable results
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Placebo-Controlled Trials
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Control group receive inactive treatment
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Where there is no standard to compare with
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Can unblind if required
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COG trial
 Cancer of the oesophagus -Gefitinib vs placebo
REACT trial
 Celecoxib
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Non-interventional trials
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Tissue samples
Blood samples
Better understanding of cancer
Improved screening programmes
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Patient Preference Trials
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PISCES
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Surveillance Trials
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FACS
Dept of Health
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Cancer Clinical Trials
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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
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Broad Portfolio
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Chemotherapy
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Radiotherapy
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Targeted Therapies
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Supportive therapies (anti-emetics/bisphosphonates)
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Genetics/Epidemiology
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Surveillance
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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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Lung Trials
ET – role of ERCC1 in non-small cell lung cancer treated with
chemotherapy
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Pancreatic Trials
ESPAC4 – addition of Capecitabine chemotherapy
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Haematology Trials
NSHLG – genetics study
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Head and Neck Trials
H&N5000 – genetics study
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Dermatology Trials
SEARCH – genetics of melanoma
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How do we decide which studies to do at
SaTH?
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UKCRN Portfolio
Academic links
Pharmaceutical links
Attend national meetings
Attend Network meetings
Consultants/SpRs
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How do we identify patients?
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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
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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
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Cost savings
 Free drugs
 Free anti-emetics and chemotherapy in ET (£11,000)
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IPSOS MORI poll in June 2011
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97% of the public believe it’s important for the NHS to
support research into new treatments
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93% want their local NHS to be encouraged or required to
support research
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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
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International Clinical Trials Day
Radio Shropshire
PPI
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R&D Committee
Raising profile in Trust
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Any questions?
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