BS - Epi/Biostat (Studies & Clinical Trials) Flashcards Preview

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Flashcards in BS - Epi/Biostat (Studies & Clinical Trials) Deck (19)
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1
Q

Which of the following studies are observational, prospective, and/or retrospective: (1) Cross-sectional study (2) Case-control study (3) Cohort study?

A

(1) Observational (2) Observational and Retrospective (3) Observation and Prospective or Retrospective

2
Q

Describe the design of cross-sectional study. What question does it ask?

A

Collects data from a group of people to assess frequency of disease (and related risk factors) at a particular point in time. Asks, “What is happening?”

3
Q

What is a measure/example of cross-sectional study?

A

Disease prevalence

4
Q

How does cross-sectional study relate to risks and causality?

A

Can show risk factor association with disease but does not establish causality

5
Q

Describe the design of the case-control study. What does it look for? What question does it ask?

A

Compares a group of people with disease to a group without disease. Looks for prior exposure or risk factor. Asks, “What happened?”

6
Q

What is a measure/example of case-control study?

A

Odds ratio (OR); “Patients with COPD had higher odds of a history of smoking than those without COPD had”

7
Q

Describe the design of a cohort study. What does it look for? What questions can it ask?

A

Compares a group with a given exposure or risk factor to a group without such exposure. Looks to see if exposure increases the likelihood of disease. Can be prospective (asks, “Who will develop disease?”) or retrospective (asks, “Who developed the disease [exposed v. unexposed]?”)

8
Q

What is a measure/example of cohort study?

A

Relative risk (RR); “Smokers had a higher risk of developing COPD than nonsmokers had.”

9
Q

Describe the design of twin concordance study.

A

Compares the frequency with which both monozygotic twins or both dizygotic twins develop same disease

10
Q

What does twin concordance study measure? What other study measures this as well?

A

Measures heritability and influence of environmental factors (“nature vs. nurture”); Adoption study

11
Q

Describe the design of adoption study.

A

Compares siblings raised by biological vs. adoptive parents

12
Q

What is a clinical trial? Describe its design.

A

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

13
Q

What improves the study quality of clinical trials?

A

Study quality improves when study is randomized, controlled, and double-blinded (i.e., neither patient nor doctor knows whether patient is in the treatment or control group)

14
Q

What defines triple-blind in the context of a clinical trial?

A

Triple-blind refers to the additional blinding of the researchers analyzing the data.

15
Q

How many major phases of a drug trial are there?

A

(1) Phase I (2) Phase II (3) Phase III (4) Phase IV

16
Q

What is the the typical study sample in Phase I of a clinical trial? What question does it ask? What is its purpose?

A

Small number of healthy volunteers; “Is it safe?” Assesses safety, toxicity, and pharmacokinetics

17
Q

What is the the typical study sample in Phase II of a clinical trial? What question does it ask? What is its purpose?

A

Small number of patients with disease of interest; “Does it work?” Assesses treatment efficacy, optimal dosing, and adverse effects

18
Q

What is the the typical study sample in Phase III of a clinical trial? What question does it ask? What is its purpose?

A

Large number of patients randomly assigned either to the treatment under investigation or to the best available treatment (or placebo); “Is it as good or better?” Compares the new treatment to the current standard of care

19
Q

What is the the typical study sample in Phase VI of a clinical trial, and in what context does it occur? What question does it ask? What is its purpose? What can result from it?

A

Postmarketing surveillance trial of patients after approval; “Can it stay?” Detects rare or long-term adverse effects. Can result in a drug being withdrawn from market.