exam clinical trail information

Question 1

clinical trials are

Answer 1

research studies involving people that try to answer a scientific question, to find ways to prevent, diagnose or treat disease.

Question 2

why clinical trials

Answer 2

Effectiveness of treatment, safety of a new drug or device, defining dose administration, testing drug formulation, exploring combination therapies, evaluating effect of therapies on quality of life

Question 3

Types of clinical trials

Answer 3

Treatment
Prevention
Screening
Supportive and palliative care

Question 4

treatment trails participants

Answer 4

Use people already with cancer and new treatments

Question 5

why treatment trials

Answer 5

ew treatments
Drugs, vaccines, approaches to surgery or rt, combinations of treatments, many newer treatment trials require people to have their tumours tested for generic changes first to see if treatment targeting specific changes might work better for them than standard treatment

Question 6

treatment trails want to find out

Answer 6

Safe dose, how should the treatment be given, does it help people live longer, side effects,

Question 7

participants in prevention trials

Answer 7

Cancer prevention trials involve healthy people. They will either be people with a high risk of developing cancer or have had cancer in the past and have a high chance of developing a new one

Question 8

prevention trials are to

Answer 8

Looking at cancer risk and ways to reduce the risk

Question 9

Researchers want to know in prevention trials

Answer 9

How safe it is for a person to take this agent or do this activity
Does the new approach prevent cancer

Question 10

Two types of prevention trails

Answer 10

Actions studies - focus on finding out wether actions people take can prevent cancer, ie exercise, fruits and vegetables
Agent studies - focus on fiding out wether taking medicines, vitamines, minerals or dietary supplements may lower the risk of a certain type of cancer

Question 11

Goal of screening trials

Answer 11

Test new ways to find disease early, when its easier to be treated

Question 12

For screening trials they want to know

Answer 12

Does finding disease earlier, before people have any symptoms, save lives
Is one screening better than another
Do the large number of people who receive screening tests undergo unnecessary follow up tests and procedures

Question 13

why do they need effective screening tests

Answer 13

Reduce the number of deaths due to the cancer screening

Question 14

Quality of life/supportive care/palliative care trials look at

Answer 14

These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatments

Question 15

quality of life/supportive care/palliative care wants to find

Answer 15

New ways to help people cope with 
Pain
Nutrition problems 
Infection 
Nausea and vomiting
Sleep disorders
Depression 
Other health problems

Question 16

quality of life trials test

Answer 16

Drugs
Activities - support groups, exercising, talking to people
Help families and caregivers cope with own needs and for the person with cancer

basically by They want to know how cancer and treatments affect patients and love ones
How they can improve their quality of life

Question 17

In vitro

Answer 17

Studies carried out in a laboratory environment

Test tubes, petri dishes ect

Question 18

In vivo

Answer 18

Effect various biological entities tested on whole, living organisms usually animals plants

Question 19

Phase 1 trials

Answer 19

Find a safe dose
Decide how the treatment is administered
How the treatment affects the human body and fights cancer
Number of cancer patient 15-30
Usually when there are no other treatment options for the patient

Question 20

Phase 2

Answer 20

Determine if it has an effect on the cancer
See how it affects the body and fights cancer
Less than 100 cancer patients take part
Can be randomised
Usually when patients have been treated with chemo,surgery, rt but these treatments have not been successful

Question 21

Phase3

Answer 21

Compare new treatment with current standard
Is the new treatment better than standard
100 - 700 thousand patients take part
Participants have equal chance to be assigned to one of two or more groups

Question 22

Phase 4

Answer 22

Used to evaluate long term safety and effectiveness of treatment
Less common phase

Question 23

Patient protection

Answer 23

Patients rights protected by 
Informed consent 
Purpose 
Procedures 
Potential risk and benefits 
Code of rights 
Scientific review 
Review boards
Ethics committee 
Data safety and monitoring boards 
Regularly review data from ongoing trials 
Ensure risk is minimised 
Ensure data integrity and validity 
Sop a trial if safety concerns