ONCOLOGY RESEARCH

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ONCOLOGY RESEARCH

• Louise Rivett
• Oncology Research Sister
• louise.rivett_at_ldh.nhs.uk
• 01582 718292

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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, CNSs, 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

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OBJECTIVES

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

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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 LD by Clinicians in collaboration
  with NCRN and West Anglia CLRN, sometimes with
  sponsorship from academic grants or charities
  e.g. CRUK

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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

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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

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• Governance
• Relating to Trial Activity

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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

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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

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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
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National Cancer Research Network (NCRN)

• Responsible for increasing involvement and
  recruitment into trials (government target 12)
• 33 Research Networks in total - LD forms part of
  the Mount Vernon Cancer Network
• Purpose - ultimately resulting in improved
  patient care

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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

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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

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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 RD approval
• Co-ordinate observational studies
• Liaise with clinical trial centres, and various
  departments to ensure smooth running of clinical
  trials for patients

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Current Number of Oncology Trials at the LD

• Breast ?
• Lung ?
• Colorectal ?
• Head Neck ?
• Urology ?
• Haematology ?
• Upper GI ?

• 14 (plus 1 in set-up)
• 3
• 3
• 3
• 2
• 6
• 2

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Types of Clinical Trial

• Randomised Controlled Trial (RCT)
• Blind
• Double blind
• Open labelled
• Placebo
• Non-Randomised Controlled Trial (non-RCT)
• Observational studies

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Trial Phases Phase 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

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Trial Phases Phase 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

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Trial Phases Phase 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
• LD Oncology Research Team offer mainly
• Phase III trials to its patients

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Randomisation

• What is randomisation?
• Its purpose?
• Preferred terms

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Patient Journey

• Potential patient identified and eligibility
  checked

Trial introduced by clinician nurse Information
given
Trial discussed with family, friends etc
Informed consent obtained after further
discussing trial
Patient randomised and treatment allocated
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
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Whats 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

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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

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Reasons why patients refuse trials

• Fear of the unknown
• Additional hospital visits
• Needle phobia
• Possible additional side effects

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Trial Misconceptions Issues surrounding
Informed Consent

• Guinea pigs?!
• Too much on plate
• Language issues
• Family influence

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ANY QUESTIONS ?