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Radiation Biology > Statistics of clinical trials > Flashcards

Statistics of clinical trials Flashcards

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AP® Biology flashcards Biology 101 flashcards
1
Q

experimental study types

A

uncontrolled trials

controlled trials

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2
Q

Observational study types

A 
case report
case series
cross sectional study
case control study
cohort study
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3
Q

purpose of descriptive study

A

develop hypothesis

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4
Q

purpose of case control study

A

investigate it’s relationship to outcomes

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5
Q

purpose of cohort study

A

define it’s meaning with exposures

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6
Q

purpose of clinical trials

A

test link experimentally

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7
Q

phase I of clinical trials

A

establish safety, dose finding

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8
Q

phase II of clinical trials

A

establish biological activity or potential efficacy

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9
Q

phase III of clinical trials

A

randomized comparison of treatment

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10
Q

phase IV of clinical trials

A

long-term surveillance in broader population

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11
Q

MTD

A

Maximum tolerated dose of new drug. part of phase I

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12
Q

Two types of experimental comparative clinical trials

A

Fixed Sample - # of patients allocated to treatment group fixed before study begins
Sequential trial - add more patients as time goes on

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13
Q

Bias

A

systematic (non-random) error in an estimate

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14
Q

Treatment allocation bias

A

those receiving one treatment or more likely to do (better or worse) than an alternative.

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15
Q

How to control bias

A

randomization

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16
Q

Intent-to-treat analysis (ITT)

A

everyone included in the analysis; comparison b/w groups ignores that some were non-compliant

17
Q

As-treated (Per protocol - PP)

A

compare only compliant patients

18
Q

Null hypothesis

A

there is no difference

19
Q

alternative hypothesis

A

there is a difference

20
Q

type II error

A

false negative

21
Q

type I error

A

false positive

22
Q

Alpha (statistics)

A

probability of type I error

23
Q

Beta (statistics)

A

probability of Type II error

24
Q

Power

A

1 - beta: probability of statistical significance

25
Q

Bonferroni Approach

A

control for type I errors

Radiation Biology (10 decks)

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