clinical trials

Question 1

interventional trial vs observational trials

Answer 1

interventional- want to see how a particular intervention affects people
observational- want to see what happens to people in different situations

Question 2

pilot studies and feasibility studies

Answer 2

Feasibility studies are designed to see if it is possible to do the main study.
Pilot studies are small versions of the main study.

Question 3

prevention trials

Answer 3

look at wether a particular treatment can help prevent cancer

Question 4

screening trials

Answer 4

tests for early signs of cancer before they have symptoms

Question 5

treatment trials

Answer 5

Researchers run treatment trials in stages. These stages are called phases. The early phases aim to find out more about the safety and side effects of a new treatments. Later phases aim to see if a new treatment works better than the current treatment.

Question 6

multi-arm multi-stage trials

Answer 6

A multi arm trial is a trial that has:
several treatment groups as well as the standard treatment group

Multi-arm multi-stage (MAMS) trials have the same control group all the way through. The other treatment groups can change as the trial goes on.

multi-arm starts at phase 3

Question 7

types of observational studies

Answer 7

Cohort studies, case control studies and cross sectional studies are all types of observational studies.

Question 8

cohort study

Answer 8

look at groups of people

A research team may recruit people who do not have cancer and collect information about them for a number of years. The researchers see who in the group develops cancer and who doesn’t. They then look to see whether the people who developed cancer had anything in common.

Question 9

case control study

Answer 9

Case control studies work the opposite way to cohort studies. The research team recruits a group of people who have a disease (cases) and a group of people who don’t (controls). They then look back to see how many people in each group were exposed to a certain risk factor.

Question 10

cross sectional studies

Answer 10

Cross sectional studies are carried out at one point in time, or over a short period of time. They find out who has been exposed to a risk factor and who has developed cancer, and see if there is a link.

Question 11

phase 0

Answer 11

• 10-20 people
• test a low dose to see it isn;t harmful
• not randomized

Question 12

phase 1

Answer 12

20-50 people

• finding out about side effects
• not randomized

Question 13

phase 2

Answer 13

• 10s-100 of people
• finding out more about side effects and seeing how well the treatment works
• sometimes randomized

for patients not responding to standard of care

Question 14

phase 3

Answer 14

• 100s to 1000s of people
• compares new treatment to standard
• usually randomized

takes several years

Question 15

phase 4

Answer 15

• medium to large number of people, variable
• find out more about long term benefits anf side effects
• not randomized
• minimum of 2 years

Question 16

pre-clinical trial

Answer 16

done on animals