The role of research in the cancer patient pathway

Question 1

What is the purpose of clinical trials for cancer?

Answer 1

• to treat cancer
• find and diagnose cancer
• prevent cancer
• manage symptoms of cancer and side effects of treatment

Question 2

What is a clinical trial?

Answer 2

• research studies involving people

- to seek and find new ways to improve treatments and quality of life for patients

Question 3

What are the requirements which clinical trials are performed under?

Answer 3

• Research governance under good clinical practice
• require research ethics committee review
• helpful guidance by national research ethics services

Question 4

What is research governance?

Answer 4

• covers principles and processes by which standards are set in research
• enhance ethical awareness and scientific quality
• promote good practice
• reduce adverse incidents and ensure lessons are learned
• forestall poor performance and misconduct

Question 5

Who does research governance apply to?

Answer 5

• design research studies
• participate in research
• host research in their organisation
• fund research proposals
• manage research
• undertake research

Question 6

What is GCP?

Answer 6

Good Clinical Practice
International, ethical and scientific quality standard for the design, conduct, recording and reporting of trials involving participation of human subjects
- ensures protection of rights and well being of research participants
- ensures research results are accurate and reliable

Question 7

What is the significance of a sponsor?

Answer 7

• all research conducted must have an identified sponsor

- responsible for the initiation, managing and financing of project

Question 8

What are the types of cancer clinical trials?

Answer 8

• treatment trials
• prevention trials
• early detection/screening trials
• diagnostic trials
• quality of life/supportive care studies

Question 9

What are the phases of clinical trials?

Answer 9

Phase 1: find a safe dose, decide how treatment given, how affects human body, look for signal of efficacy
Phase 2: assess efficacy in specific cancer type, response rate, duration of response, overall survival, assess safety
Phase 3: compare new treatment with current standard treatment
Phase4: look at LT safety and effectiveness, after new treatment approved and on the market

Question 10

What are the benefits of participation?

Answer 10

• patients receive minimum best standard treatment
• if new treatment proven to work patients among first to benefit
• patients have chance to help others and improve cancer care