Clinical Trial Design

Question 1

uses of a clinical study

Answer 1

tests and proves the efficacy of a drug, also gives ideas as to the risks involved in drug use

Question 2

basic consideration involved in trial design

Answer 2

aims, how many subjects, randomised or double blind or crossover or parallel, placebo or not, ethics, results assessment, dosage regime

Question 3

parallel design

Answer 3

compares two or more treatments. Participants are randomly assigned to either group, treatments are administered, and then the results are compared. phase 3 clinical trials(1). random assignment is a key element

Question 4

importance of statistical power

Answer 4

Having enough statistical power is necessary to draw accurate conclusions about a population using sample data

Question 5

statistical significance and clinical significance difference

Answer 5

clinical significance is the practical importance of a treatment effect—whether it has a real genuine, palpable, noticeable effect on daily life. statistical significance is assigned to a result when an event is found to be unlikely to have occurred by chance.

Question 6

phase 1

Answer 6

to see side effects and what happens to treatment in the body. small. not random

Question 7

phase 2

Answer 7

medium sized. sometimes random, sees how well the treatment works in the body

Question 8

phase 3

Answer 8

large. usually random. compare new treatment to the standard treatment

Question 9

phase 0

Answer 9

test to check if harmful

Question 10

phase 4

Answer 10

drug is licensed and works. trial to see long term effects