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Cancer > The Role of Research in the Cancer patient pathway > Flashcards

The Role of Research in the Cancer patient pathway Flashcards

1
Q

what are clinical trials

A

Clinical trials are research studies that involve people. Through clinical trials, we seek to find new ways to improve treatments and the quality of life for our patients

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2
Q

why do we have clinical trials

A

■ Treat cancer
■ Find and diagnose cancer - early detection can provide a better outcome for treatment
■ Prevent cancer
■ Manage symptoms of cancer and side effects from its treatment

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3
Q

what is important in clinical trials before it is tested in patients

A

the risk of the drug and the side effects that it may cause

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4
Q

what rules are clinical trails performed under

A

Clinical trials are performed under very strict Research Governance under Good Clinical Practice and require Research Ethics Committee (REC) review

  • legal requirements
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5
Q

What should happen before any new treatment is used in people

A

Before any new treatment is used with people in clinical trials, researchers work to understand its effects on cancer cells in the lab and in animals.

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6
Q

what is research governance

A

Research Governance is the term covering the principles and processes by which standards are set in research.

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7
Q

How does research governance improve research and safeguards the pubic

A
  • enhancing ethical awareness and scientific quality
  • promoting good practice
  • reducing adverse incidents and ensuring lessons are learned
  • forestalling poor performance and misconduct
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8
Q

Who does research governance apply to

A

Research Governance applies for all staff, in all professional groups, no matter how senior or junior working in all health and social care research environments who:

  • design research studies
  • participate in research
  • host research in their organisation
  • fund research proposals or infrastructure
  • manage research
  • undertake research
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9
Q

What does the research governance framework entail

A

Ethics (The dignity, rights, safety & wellbeing of participants must be the primary consideration in any research study)

Science (must ensure only high quality, valid research is conducted as determined by independent scientific review of research proposals)

Health & Safety (research can use potentially dangerous equipment, substances or organisms so patient and researcher safety is paramount)

Information (allow public access to information on research being conducted and the findings from research)

Finance (financial probity, consideration of adequate insurance cover for research, arrangements for intellectual property, contracting)

Quality Research Culture (promotion of excellence in research in the UK)

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10
Q

What is good clinical practise

A

GCP is an international ethical and scientific quality standard for the design, conduct, recording and reporting of trials that involve the participation of human subjects

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11
Q

What is the purpose of good clinical practise

A
  • protects the rights and well being of research participants
  • ensures that the results of research are accurate and credible
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12
Q

Where are the origin of good clinical practise

A

in the Declaration of Helsinki

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13
Q

Name the UK regulations that are involved in the conduct of research in the UK

A

DH Research governance framework for health and social care (2nd Edition Sept 2005)

EU Clinical Trials Directive transposed into UK law through the Medicines for Human Use (Clinical Trials) Regulations 2004

EU Medical Devices Directives implemented in the UK through the Medical Devices Regulations 2002

Human Tissue Act 2004 (fully implemented Sept 2006)

Mental Capacity Act 2005 (fully implemented Oct 2007)

Data Protection Act 1998 and Freedom of Information Act 2000

Governance arrangements for NHS Research Ethics Committees (GAfREC)

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14
Q

How do you undertake research in the NHS

A

we need to:

  • aware of how clinical research is governed in the UK and the approvals that must be in place before the research begins
  • Obtain permission to conduct the research from NHS R&D and the trust where the research is to run
  • Prepare your submission to the REC which is completed through a system known as IRAS (Integrated Research Application System)
  • For certain research projects a new centralised system for NHS approval is used known as NIHR CSP: NHIR Co-ordinated System for gaining NHS Permission
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15
Q

what must all research conducted have

A

a sponsor

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16
Q

What is the sponosr

A

The Sponsor is the individual or organisation responsible for initiation, managing and financing of the research project.
e.g. it may be the trust, the medical school or a pharmaceutical company

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17
Q

What must the sponsor ensure

A

The research team hold the necessary contracts with the Trust and are appropriately qualified to conduct the research

Arrangements are in place locally to deliver the research as proposed in the research protocol

Through independent peer review the scientific quality of the research is assured

All necessary approvals are obtained prior to the research commencing (REC approval, MHRA approval, all local approvals etc)

Responsibilities for the management, monitoring and reporting of the research are delegated appropriately

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18
Q

what are the aims of the EU clinical trials directive

A

The aims of the Directive and the subsequent regulations were to harmonise the regulation of clinical trials, improve the rights, privacy and protection of research participants in accordance with Good Clinical Practice (GCP)

The Directive applies to any clinical trial of an Investigational Medicinal Product (IMP)

Recently Trust R&D has received applications for approval of trials involving ATMPs (Advanced Therapy Medicinal Products) as well as CTIMPs

19
Q

What does the human tissue act do

A

Identifies the range of activities for which a licence will be required
(the Trust and the University hold licences from the HTA)

Prohibits the conduct of certain activities without a licence

Establishes penalties (including custodial sentences)

Prohibits commercial dealing in human material

20
Q

What is the human tissue act

A
  • human tissue authority for the removal, storage, use and disposal of human bodies, organs and tissue from the living and deceased
21
Q

What is the fundamental principle of the human tissue act

A

consent

  • consent is broadly required to store and use relevant material from the living for a number of ‘scheduled purposes’, including ‘research in connection with disorders, or the functioning of, the human body’.
  • Consent is also required to remove, store and use relevant material from a deceased person.
  • This consent must be both appropriate and valid.
22
Q

What 4 things do you need to use human tissue samples in research

A
  • consent
  • ethics review from an NHS REC
  • HTA licence
  • transfer of tissue
23
Q

describe the 4 things needed to use human tissue samples in research

A

Consent

  • Need consent to collect and use tissue in research in most cases
  • Consent can be for use of tissue samples in a specific research project or generic to allow for use of samples in future unspecified research

Ethics review from an NHS REC
- Ethical approval from an NHS REC can be project specific or generic if it is obtained for the initiation of a Research Tissue Bank (RTB)

HTA Licence
- A licence is required for storage of tissue for research purposes only if you are storing licensable tissue (relevant material) for unspecified research purposes

Transfer of tissue
- Material Transfer Agreements (MTA) are required for the transfer of tissue to or from an RTB or other organisation

24
Q

What are the 5 types of cancer clinical trails

A
  1. Treatment trials
  2. Prevention trials
  3. Early-detection trials/screening trials
  4. Diagnostic trials
  5. .Quality-of-life studies/supportive care studies
25
Q

Describe the 5 types of cancer clinical trails

A
  1. Treatment trials seek to find out:
    · What new treatment approaches can help people who have cancer
    · What is the most effective treatment for people who have cancer
  2. Prevention trials seek to find out what approaches can prevent a specific type of cancer from developing in people who have not previously had cancer - action and agent studies
  3. Early-detection/screening trials seek to discover new ways of finding cancer in people before they have any cancer symptoms
  4. Diagnostic trials seek to find out how new tests or procedures can better identify cancer in people when we think it is there
  5. Quality-of-life/supportive care trials seek to find out what kinds of new approaches can improve the comfort and quality of life of people who have cancer
26
Q

in cancer prevention trials what is the purpose of it

A

Evaluate the effectiveness of ways to reduce the risk of cancer

27
Q

What are the two types of prevention trials

A

action studies - doing something

agent studies - taking something - these are also called chemoprevention studies

28
Q

What are the phases of a clinical trial

A

Phase 1
Phase 2
Phase 3
Phase 4

29
Q

What is the purpose of phase 1

A
  • To find a safe dose
  • To decide how (treatment schedule) the new treatment should be given
  • To see how the new treatment affects the human body
  • To look for a signal of efficacy in certain types of cancer
30
Q

what is the purpose of phase 2

A

• To assess the efficacy in a specific cancer type endpoints: response rates,
duration of response, overall survival
• To assess safety

31
Q

What is the purpose of phase 3

A

• To compare the new treatment (or new use of a treatment) with the current standard treatment

32
Q

what does randomised do

A
  • gets rid of biased
  • provides the best way to prove the effectivenss of a new agent or intervention
  • often requires stratification to ensure the groups are really simialr
33
Q

what phases can you combine

A

Some researchers design trials that combine two phases (phase 1/2 or phase 2/3 trials) in a single trial. This allows a seamless transition between trial phases, which may allow research questions to be answered more quickly or with fewer patients.

34
Q

What are phase 0 trials

A

Phase 0 trials are very small trials that help researchers decide if a new drug should be tested in a phase 1 trial.

35
Q

What does phase 4 trials look at

A

Phase 4 trials look at long‑term safety and effectiveness. They take place after a new treatment has been approved and is on the market

36
Q

when are placebos used

A

Placebos are used only when no standard treatment exists

Patients are told of this possibility before deciding to take part

There is a question of EQUIPOISE if the new treatment if clearly superior to the old standard

37
Q

placebos are almost …

A

Never used in cancer treatmetn trials

38
Q

What are placebos

A

treatments, often drugs, designed to look like the medicine being tested but that don’t contain any active ingredient

39
Q

What is the clinical trial protocol

A

A recipe or blueprint
Strict scientific guidelines:
- Purpose of study
- How many people will participate (set in advance)
- Who is eligible to participate (Eligibility Criteria)
- How the study will be carried out
- What information will be gathered about participants
- Endpoints

40
Q

What are the benefits of participation

A

Possible benefits:

  • Patients will receive, at a minimum, the best standard treatment
  • If the new treatment or intervention is proven to work, patients may be among the first to benefit
  • Patients have a chance to help others and improve cancer care
41
Q

How are patients rights protected

A

Informed consent

Scientific review

Institutional review boards (IRBs)

Data safety and monitoring boards

42
Q

Why do few cancer patients participate in clinical trials

A

Don’t know about clinical trials
Don’t have access to trials
May be afraid or suspicious of research
Can’t afford to participate
May not want to go against physician’s wishes

43
Q

Why do so few doctors participate in clinical trials

A

Lack awareness of appropriate clinical trials

Be unwilling to “lose control” of a person’s care

Believe that standard therapy is best

Be concerned that clinical trials add administrative burdens

Cancer (13 decks)

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