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Published byDominique Ipsen Modified over 9 years ago
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1 Cancer Clinical Trials at SaTH Helen Moore - Lead Research Nurse 9 th JULY 2103
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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
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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
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4 Recruitment Targets:- 399 cancer patients 2012-2013 172 into randomised controlled trials 1600 in total (cancer and non-cancer)
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5 Why Do We Need Clinical Research?
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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
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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)
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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
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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
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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!
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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
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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
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15 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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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
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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
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18 Non-interventional trials Tissue samples Blood samples Better understanding of cancer Improved screening programmes
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19 Patient Preference Trials PISCES
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20 Surveillance Trials FACS Dept of Health
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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
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22 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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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
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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
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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
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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
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27 Lung Trials ET – role of ERCC1 in non-small cell lung cancer treated with chemotherapy
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28 Pancreatic Trials ESPAC4 – addition of Capecitabine chemotherapy
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29 Haematology Trials NSHLG – genetics study
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30 Head and Neck Trials H&N5000 – genetics study
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31 Dermatology Trials SEARCH – genetics of melanoma
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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
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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
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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)
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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
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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
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39 International Clinical Trials Day Radio Shropshire PPI R&D Committee Raising profile in Trust
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41 Any questions?
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