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ONCOLOGY RESEARCH

ONCOLOGY RESEARCH. Louise Rivett Oncology Research Sister louise.rivett@ldh.nhs.uk 01582 718292. The Research Team who are we?. Louise Rivett Senior Research Sister Clare Hamilton Research Sister Emma Laing Clinical Trials Coordinator

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ONCOLOGY RESEARCH

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  1. ONCOLOGY RESEARCH Louise Rivett Oncology Research Sister louise.rivett@ldh.nhs.uk 01582 718292

  2. The Research Teamwho are we? Louise Rivett Senior Research Sister Clare Hamilton Research Sister Emma Laing Clinical Trials Coordinator • We work with Oncologists, Surgeons, Physicians, Radiologists, CNS’s, Chemotherapy Nurses and Radiographers as well as a variety of other ancillary and administrative staff • We run trials in many different tumour sites: Breast, Lung, Colorectal, Haematology, Upper GI, Urology and Head & Neck

  3. OBJECTIVES • What are they and why do we need them • Overview of Oncology Research at the L&D • Roles of team members • Governance relating to trial activity • Phases and types of trials • Trial patient journey • Randomisation • Issues affecting trial participation

  4. What are ‘Clinical Trials’? • Clinical trials are research studies that involve patients or healthy people and are designed to test new treatments • Run at the L&D by Clinicians in collaboration with NCRN and West Anglia CLRN, sometimes with sponsorship from academic grants or charities e.g. CRUK

  5. What do trials aim to do? • Prevent disease and reduce the number of people who become ill • Treat illness to improve survival or increase the number of people cured • Improve the quality of life for people living with illness • Diagnose diseases and health problems

  6. Why are trials important? • To gain evidence to know which treatments work best • To reduce the risk of giving treatments which have no advantage, waste resources or are harmful • To gather evidence that a treatment is safe and has no serious side effects

  7. Governance Relating to Trial Activity

  8. Research Governance AIMS: • To promote a quality research culture • To promote excellence • To promote strong leadership for research • To implement standards – GCP, DoH guidelines etc…

  9. EU Directive (became Law 2004) AIMS: • To protect the human, ethical & moral rights as well as the safety and well-being of trial participants • To simplify and harmonise administrative provisions governing clinical trials, and ensuring the credibility of results

  10. ICH-GCP “Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects” ICH Harmonised Tripartite Guidelines for Good Clinical Practice – The Institute of Clinical Research (1997) ICH = International Conference on Harmonisation GCP = Good Clinical Practice

  11. National Cancer Research Network(NCRN) • Responsible for increasing involvement and recruitment into trials (government target 12%) • 33 Research Networks in total - L&D forms part of the Mount Vernon Cancer Network • Purpose - ultimately resulting in improved patient care

  12. West Anglia CLRN • West Anglia Comprehensive Local Research Network (CLRN) is one of 25 CLRNs across England which form part of the NIHR Comprehensive Clinical Research Network (CCRN) • CCRN provides support for clinical trials and other well designed studies in all areas of disease and clinical need

  13. Role of Research Nurses • Develop the service for trial activity • Raise the profile of trials in the Trust • Screen, recruit, treat & follow up patients • Ensure accuracy of data reporting • Ensure principles of GCP adhered to

  14. Role of Trial Coordinator • Co-ordinate, manage and take responsibility for accurate and complete clinical trial data in accordance with protocol and the Data Protection Act • Trial protocol amendments • Trial set up – includes ethical and R&D approval • Co-ordinate observational studies • Liaise with clinical trial centres, and various departments to ensure smooth running of clinical trials for patients

  15. Current Number of Oncology Trials at the L&D Breast  Lung  Colorectal  Head & Neck  Urology  Haematology  Upper GI  14 (plus 1 in set-up) 3 3 3 2 6 2

  16. Types of Clinical Trial Randomised Controlled Trial (RCT) • Blind • Double blind • Open labelled • Placebo Non-Randomised Controlled Trial (non-RCT) • Observational studies

  17. Trial PhasesPhase I Studies are offered to people whose cancer has come back or spread and there is no standard treatment that may help them, or to healthy, paid volunteers. Phase I clinical trials aim to find out: • What effect the drug has on the body (Pharmacodynamics) • What effect the body has on the drug (Pharmocokinetics) • Side effects • Whether the drug has anti-cancer properties

  18. Trial PhasesPhase II Aim of Phase II clinical trials is to see: • How many people the drug is effective for • What types of cancer it may be used for

  19. Trial PhasesPhase III The aim of clinical trials in Phase III is to: • Compare the effectiveness of the new treatment or intervention with that of the current “gold standard” treatment L&D Oncology Research Team offer mainly Phase III trials to its patients

  20. Randomisation • What is randomisation? • Its purpose? • Preferred terms

  21. Patient Journey Potential patient identified and eligibility checked Trial introduced by clinician & nurse Information given Trial discussed with family, friends etc… Patient randomised and treatment allocated Informed consent obtained after further discussing trial Treatment phase then follow up Evidence reviewed by NICE & new drugs or regimens approved & licenced, or new standards of care recommended Trial results published in medical journals

  22. What’s new and exciting? As well as testing new drugs or combinations of drugs, trials can test new uses of old drugs! • Thalidomide • Celecoxib • Metformin • Pravastatin • Daltaparin • Zometa

  23. Reasons why patients enter trials • Access to new drugs before they are widely available • Reassurance of additional visits to Oncology Clinic • Contribution to medical research • Belief that trial participation may give improved outcome

  24. Reasons why patients refuse trials • Fear of the unknown • Additional hospital visits • Needle phobia • Possible additional side effects

  25. Trial Misconceptions &Issues surrounding Informed Consent • Guinea pigs?! • Too much on plate • Language issues • Family influence

  26. ANY QUESTIONS ?

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