Carlos Shared "01 Public Health Sciences (Biostat)" - 7 Picmonics
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01 Public Health Sciences (Biostat)
(Asks) "What's Happening?"
Data at One Specific Point in Time
(Finds) Frequency of Disease
Case Control Study
Compares those with disease to those without
(Asks) "What happened?"
Studies risk from exposure
(Asks) "Who developed disease?"
(Asks) "Who will develop disease?"
Twin concordance study
Compares the frequency with which both monozygotic twins vs both dizygotic twins develop the same disease.
Measures heritability and influence of environmental factors (“nature vs nurture”).
Compares siblings raised by biological vs adoptive parents.
Measures heritability and influence of environmental factors.
In a crossover study, subjects are randomly allocated to a sequence of 2 or more treatments given consecutively.
The simplest model is the AB/BA type of study in which subjects allocated to the AB study arm receive treatment A followed by treatment B and vice versa in the BA arm.
Crossover trials allow the patients to serve as their own controls.
The principal drawback of crossover trials is that the effects of one treatment may "carry over" and alter the response to subsequent treatments. To limit this disadvantage, a washout (no treatment) period is often added between consecutive treatments.
The washout period is designed to be long enough to allow the effects of prior treatment to wear off.
Clinical Trial Phases
Experimental study involving humans.
Compares therapeutic benefits of 2 or more treatments, or of treatment and placebo.
Study quality improves when study is randomized, controlled, and double-blinded (ie, neither patient nor doctor knows whether the patient is in the treatment or control group)
Triple-blind refers to the additional blinding of the researchers analyzing the data.
Four phases (“Does the drug SWIM?”).
Small number of healthy volunteers or patients with disease of interest.
“Is it Safe?” Assesses safety, toxicity, pharmacokinetics, and pharmacodynamics.
Moderate number of patients with disease of interest
“Does it Work?” Assesses treatment efficacy, optimal dosing, and adverse effects.
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 (any Improvement?).
Postmarketing surveillance of patients after treatment is approved.
“Can it stay?” Detects rare or long-term adverse effects. Can result in treatment being withdrawn from Market.
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