intro to clinical trials

Question 1

during clinical trials you always need to…

Answer 1

compare with a control group

Question 2

what can you assess through clinical trials

Answer 2

devices, biomarkers, diagnostic tests, screening programmes

Question 3

what are clinical trials

Answer 3

specific experimental ways of testing a clinical question

Question 4

differences in outcomes between treatment groups may be due too

Answer 4

treatment effect
bias
chance

Question 5

the best way to create a control group similar to the treatment group is too…

Answer 5

randmise all aspects

Question 6

what are randomised clinical trials

Answer 6

therapies are allocated by a chance mechanism

Question 7

what are the advantages of randomised control trials

Answer 7

1. eliminates selection bias
2. balance prognostic factors
3. validity of statistical tests

Question 8

what is a controlled clinical trials

Answer 8

prospective study comparing effects and value of intervention against a control of Human subjects

Question 9

what are randomised clinical trials

Answer 9

controlled trials where therapies are allocated by a chance mechanism

Question 10

what is an uncontrolled clinical trial

Answer 10

involves no control group

Question 11

which is the best design that reduces bias

Answer 11

randomised control

Question 12

randomisation reduces what type of bias

Answer 12

selection and allocation bias

Question 13

what is a placebo

Answer 13

a control group receives on inactive substance that looks like the drug or treatment being tested

Question 14

blind trials strengthen what…

Answer 14

randomisation

Question 15

what is a single blind trial

Answer 15

patient does not know if they are in experimental or control group

Question 16

what is a double blind trial

Answer 16

patient and clinical does not know the experimental or control group

Question 17

a placebo must be

Answer 17

identical to the active drug in taste, appearance and texture

Question 18

what is non-compliance

Answer 18

when not every participant remains in the trial or when not every patient complies with their allocated treatment

Question 19

to understand if the new treatment is better than the standard treatment there are two things we need to address…

Answer 19

1- Is the physiological action of the new treatment better than the standard.
2. IS the new treatment better than the standard treatment in routine practise

Question 20

what are explanatory trials

Answer 20

analyses only those who completed follow-up and complied with treatment

Question 21

what is a negative of an explanatory trial

Answer 21

loses randomisation

Question 22

explanatory trials are also called

Answer 22

as-treated analysis

Question 23

pragmatic trials are also called

Answer 23

intention to treat

Question 24

which type of trial gives a larger sample size

Answer 24

as-treated

Question 25

which type of trial reflect effects in clinical practise

Answer 25

intention to treat

Question 26

what is clinical equipoise

Answer 26

reasonable uncertainty that the person assigning people to groups does not know which treatment is better thus randomisation does not deny the patient the best treatment