lecture 6 Flashcards

clinical trials

1
Q

what factors must be considered when setting up and running clinical trial

A

consent, controls, randomisation, blinding

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2
Q

consent

A

given before research, full information given, enter freely

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3
Q

controls

A

control group used as a standard, don’t receive treatment

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4
Q

randomisation

A

treatments assigned to patients by chance, avoid bias

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5
Q

randomisation types

A

simple, block and stratified

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6
Q

simple randomisation

A

based on a single sequence of assignments, groups can still be uneven

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7
Q

block randomisation

A

researcher determines the block size, gives equal sample sizes, calculates all combinations

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8
Q

stratified randomisation

A

extension of block randomisation, controls and balances influenced of covariates, generates a separate block for each combination of covariates

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9
Q

blinding

A

prevents reuses from being influenced by researchers and participants, single/double blinding, allows accurate data collection

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10
Q

placebo

A

looks like the real thing but has no active ingredient

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11
Q

hypothesis

A

proposed assumption that may or may not be true

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12
Q

hypothesis testing

A

evaluation done to either confirm/dissaprove a hypothesis

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13
Q

null hypothesis

A

captures our current situation “new medicine is no better than the current treatment’

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14
Q

alternative hypothesis

A

captures what we want to achieve by doing the trial “new medicine is better than the current”

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15
Q

sample size must be

A

large enough to have a good chance of distinguishing real effects

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16
Q

types of end points

A

true and surrogate

17
Q

true endpoint

A

clinically meaningful endpoint that reflects how a patient feels, functions, or survives

18
Q

surrogate endpoint

A

occurs before the true endpoint and is used to predict the true endpoint