10 - The role of research in Cancer

Question 1

What is a research governance

Answer 1

The principles and processes by which standards are set in research

Question 2

How does research governance improve research and safeguard the public

Answer 2

Enhancing ethical awareness
Promoting good practice
Reducing adverse incidents

Question 3

What is the research governance framework

Answer 3

Developed by the DH to set out the principles, requirements and standards expected for the conduct of clinical and non-clinical research in the UK

Question 4

What does the research governance framework cover

Answer 4

	Ethics
	Science
	Health and safety 
	Information
	Finance
	Quality Research Culture

Question 5

What is the Good Clinical Practice

Answer 5

• International ethical and scientific quality standard for the design, conduct, recording and reporting of trials that involve the participation of human subjects

Question 6

Purpose of GCP

Answer 6

o The protection of the rights and well being of research participants
o That results of research are accurate and credible

Question 7

Origin of CGP

Answer 7

Declaration of Helsinki

Question 8

What is a sponsorship

Answer 8

o individual or organisation which takes responsibility for the initiation, management and financing of the research project.

Question 9

Who may a sponsor be

Answer 9

o The sponsor may be the Trust, the Medical School, or a Pharamceutical Company

Question 10

What do you need to use human tissue samples in research

Answer 10

o Consent
o Ethics review from an NHS REC
o HTA Licence
o Transfer or tissue licence

Question 11

Action studies

Answer 11

Doing something

Question 12

Agent studies

Answer 12

taking something

Question 13

Phase 1 of clinical trial

Answer 13

Safe dose
how treatment given
How the treatment affects the human body
Signal of efficacy in cancers

Question 14

Phase 2 of clinical trial

Answer 14

o	To assess the efficacy in a specific cancer type endpoints:
	response rates
	duration of response
	survival 
o	To assess safety

Question 15

Phase 3 of clinical trials

Answer 15

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

Question 16

Phase 0

Answer 16

small trials to help researchers decide if a new drug should be tested in a phase 1 trial

Question 17

Phase 4

Answer 17

look at long-term safety and effectiveness

after the treatment is on the market

Question 18

Placebos in cancer trails

Answer 18

Never used unless no standard treatment

- pts are told

Question 19

Clinical trial protocol

Answer 19

o Purpose of study
o How many people will participate (set in advance)
o Who is eligible to participate (Eligibility Criteria)
o How the study will be carried out
o What information will be gathered about participants
o Endpoints

Question 20

How are patients rights protected

Answer 20

• Informed consent
• Scientific review
• Institutional review boards (IRBs)
• Data safety and monitoring boards