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HSPH Y2 > Randomised Control Trials > Flashcards

Randomised Control Trials Flashcards

1
Q

Clinical trial

A

Experiment in which a treatment is administered to humans in order to evaluate its efficacy and safety

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2
Q

Uncontrolled trial

A

Everyone gets treatment

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3
Q

Controlled trial

A

Treated group compared to untreated group or group having normal treatment

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4
Q

Randomised controlled trial

A

Controlled trial with allocation to groups determined by chance

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5
Q

Geographical control

A

Pts w same disorder seen at another hospital/clinic where new intervention not provided

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6
Q

Historical control

A

Pts w same disorder seen in the past before the use of new intervention

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7
Q

What type of bias is introduced by the selection of individuals, groups, or data for analysis in such a way that proper randomization is not achieved, thereby failing to ensure that the sample obtained is representative of the population intended to be analyzed

A

Selection bias

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8
Q

Why is alternate allocation not used for clinical trials

A

Clinician/patient can predict treatment to be recieved

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9
Q

Benefits of randomised controls

A

Ensure groups being studied are similar
Avoids selection/allocation bias
Only systematic difference between treatment and control groups is the treatment

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10
Q

Are trial patients allocated to groups before or after being deemed eligible and consenting to the trial

A

After

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11
Q

Single blind trial

A

Pt doesn’t know what treatment they are on

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12
Q

Double blind trial

A

Pt and observers do not know what treatment they are on

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13
Q

2 types of randomised controlled trial

A

Parallel
Cross over

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14
Q

What is an AB/BA crossover study

A

Pts in group A and B ->1 group treated 1 not -> outcomes recorded -> groups switch which is treated and which isnt -> outcomes recorded

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15
Q

When are parallel trials used

A

When effect of treatment not reversible

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16
Q

When are crossover trials used

A

When effect of treatment is reversible

17
Q

Advantages of cross over trials

A

Each pt is their own control
Smaller sample size needed for same nbr of observations
Useful for subjective measurements

18
Q

Disadvantages of crossover trials

A

More time consuming
Carry over effects

19
Q

How are carry over effects prevented in crossover trials

A

Washout period between 1st and second treatment periods

20
Q

Cluster randomised trials

A

pre-existing groups of individuals are randomly allocated to treatment arms, eg villages, schools, gps

21
Q

Factorial controlled trial

A

test the effect of two or more treatments simultaneously using various combinations of the treatments.

22
Q

What stage of developing a drug uses in vitro and in vivo animal testing

A

Preclinical

23
Q

Purposes of each stage of drug testing

A

Preclinical - preliminary efficacy, toxicity and pharmacokinetics in animals
Phase 0 - pharmacokinetics and pharmacodynamics
Phase 1 - safety
Phase 2 - efficacy and safety
Phase 3 - therapeutic effect
Phase 4 - pharmacovigilance

24
Q

Advantages of trial registries

A

Assist in planning
Avoid research duplication
Encourage collaboration
Optimise use of funds
Incr pt access to info
Improve recruitment
Detect bias

25
Q

How to calculate relative risk of death in treatment group compared to control

A

Risk of death in treatment/risk of death in control

26
Q

Intention to treat

A

Comparison of all subjects based on treatment group assigned regardless of whether they complied

27
Q

On treatment

A

Comparison of subjects who actually took treatment

28
Q

How can compliance in trials be increased

A

Selection of patients
Double blind design
Run in period where all are treated to identify those who can’t tolerate treatment

29
Q

How to calculate how many people need a treatment to prevent an event

A

100/ difference in risk between treatment and control groups

30
Q

Purpose of meta analysis

A

Bring together all evidence to more powerfully estimate effect size

31
Q

What type of graph are meta analysis results usually shown in

A

Forest plot

32
Q

Issues in meta analysis

A

Heterogeneity in study results
Publication bias

33
Q

What causes heterogeneity in study results

A

Different study designs
Different participant characteristics
Differences in intervention
Chance

34
Q

What causes publication bias

A

Studies with significant/favourable results more likely to be published

HSPH Y2 (7 decks)

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