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Behavioral > Clinical trials and type of studies > Flashcards

Clinical trials and type of studies Flashcards

1
Q

Clinical trial - definition

A

Experimental study involving humans. Compares therapeutic benefits of 2 or more treatments, or the treatment and placebo

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1
Q

Double blinded study

A

Neither patient nor doctor knows whether the patient is in the treatment or control group

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2
Q

Clinical trial study quality improves when study is

A
  1. Randomized
  2. Controlled
  3. Double blinded
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3
Q

Triple blind refers to

A

The additional blinding of the researchers analyzing data

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4
Q

Clinical trial. Number of phases

A

4 (I-IV)

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5
Q

Clinical trial phase 1 sample

A

Small number of healthy volenteers

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6
Q

Clinical trial phase 1 purpose

A

Assesses

  1. safety (is it safe?)
  2. toxicity
  3. pharmacokinetics
  4. Pharmacodynamics
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7
Q

Clinical trial phase 2 sample

A

Small number of patients with disease of interest

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8
Q

Clinical trial phase 2 purpose

A

Assess treatment

  1. efficacy (does it work?)
  2. optimal dosing
  3. adverse effects
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9
Q

Clinical trial phase 3 sample

A

Large number of patients randomly assigned either to the treatment under investigation or the best available treatment (or placedo)

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10
Q

Clinical trial phase 3 purpose

A

Compares the new treatment to the current standard of care (is it as good or better?)

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11
Q

Clinical trial phase 4 sample

A

Postmarketing surveillance trial of patients after approval

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12
Q

Clinical trial phase 4 purpose

A

Detects rare or long term adverse effects. Can result in a drug withdrawn from market (can it stay?)

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13
Q

Types of studies

A
  1. Cross-sectional study
  2. Case-control study
  3. Cohort study
  4. Twin concordance
  5. Adoption study
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14
Q

Adoption study design

A

Compares sibling raised by biological vs adoptive parents

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15
Q

Adoption study measures

A

Heritability and influence of environmental factors

16
Q

Twin concordance study measures

A

Heritability and influence of environmental factors (nature vs nurture)

17
Q

Twin concordance study design

A

Compares frequency with which both monozygotes twins or both dizygotic twins develop same disease

18
Q

Cross-sectional study type

A

Observational

19
Q

Cross-sectional study design

A

Collects data from a group of people to assess frequency of disease and related factors at a particular point in time (disease PREVALENCE)

20
Q

Cross-sectional study/ask

A

What is happening?

21
Q

Case control study type

A

Observational and retrospective

22
Q

Cross-sectional study measures

A
  1. Disease prevalence

2. Can show risk factor association with disease (but does not establish causality)

23
Q

Case control study/asks

A

What happened

24
Q

Case control study design

A
  1. Compares a group of people with disease to a group without disease
  2. Look for prior exposure or risk factors
25
Q

Case control study measure

A

Odds ration (OR)

26
Q

Case control study example (copd-smoking)

A

Patients with copd had higher odds of a history of smoking than those without copd

27
Q

Cohort study type

A

Observational and prospective or retrospective

28
Q

Cohort study design

A
  1. Compares a group with a given exposure of risk factor to a group without such exposure
  2. Looks to see if exposure increases the likehood of disease
  3. Can be prospective (who will develop the disease) or retrospective (historical) (who developed the disease)
29
Q

Cohort study measure

A

Relative risk

30
Q

Cohort study/ask

A

Who developed the disease
Or
Who will develop the disease (exposed vs not exposed)

31
Q

Cohort study example (copd/smoker)

A

Smokers had a higher risk of developing copd than nonsmokers

32
Q

Odd ratio study

A

Case control study

34
Q

Relative risk study

A

Cohort study

35
Q

cohort vs case control according to design

A

cohort: exposure vs no exposure

case control study: disease vs no disease (control)

36
Q

Cohort study type according to time

A
  1. prospective (concurrent)

2. cohort (historical - nonconcurrent)

37
Q

Clinical treatment trials - type of study (why)

A

cohort study –> some members with a specific illness are given one treatment and other members are given another treatment or placebo

38
Q

Clinical trial compares

A

2 or more treamtments or

Treatment and placebo

Behavioral (13 decks)

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