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Flashcards in Clinical Trials Deck (45)
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31

What is a retrospective study?

Looks backwards and examines exposure to risk factors in relation to outcome that are established at the start of the study

32

What can different studies involve comparisions with?

Placebo

Other therapy

Cross over design

33

What is a cross over design?

Patient is given additional treatment which is being tested

34

What is a randomised control study?

One where patients are assigned to one of the groups at random

35

What are some disadvantages of randomised control?

Generalised (subjects may not represent patient population)

Recruitment (twice as many new patients needed for the study)

Acceptability (some physicians or patients will refuse)

Administrative complexity (randomisation methods etc)

36

What does superiority design show?

New treatment is better than the control or standard treatment

37

What does non-inferiority design show?

Not worse than standard treatment by more than some margin

Would have beaten placebo if it had been included

38

What should the end points of a design be?

Simple, such as:

 

Death

Number of hospital admissions

Lowering of blood pressure

39

What do you need to consider when designing a study?

Choice of subjects (enough to be able to detect or reject differences between groups)

Choice of control drug (placebo or another drug)

Choice of patients (age, race, sex, diseases and drugs)

Exclusion and selection criteria (pregnant woman, children, seriously ill patients, elderly)

40

41

What are challenges with trials that involve the elderly?

They usually have multiple conditions

42

What do you need to consider when analysing and interpreting data?

Statistical test

Are differences due to chance

O<0.05 usually taken as significance

43

What are some ethics that must be considered?

Consent

Ethics committee

Placebos

Children

44

How long can overall development of the drug from initial research to its first launch take?

Up to 20 years

45

What is post marketting surveillance done by?

Medicines and Healthcare devices Regulatory Authority (MHRA)

Yellow card system