14 Examples from Infectious Disease Epidemiology Flashcards Preview

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Flashcards in 14 Examples from Infectious Disease Epidemiology Deck (12)
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When is a placebo acceptable as a comparator?

When there is no current standard of care


What is generalizability?

Same as external validity
Can the results of this study be expected to be similar in my patients
Is the outcome relevant to my patient population
Does the study compare the new treatment to the treatment currently used for my patients


Catastrophic disability

Loss of independence in 3 or more basic levels of care
Often means going to a nursing home or needing an in home nurse


Internal validity

How well a study was conducted and how reliable the results from the study are
How assured you can be if there is a difference in the trial that it is due to the vaccine and not something else


How to calculate efficacy

((Rate in those who receive placebo) - (rate in those who receive treatment)) / rate in those who receive placebo


Phase 1 of clinical studies

20-80 study subjects
Done in healthy adults
Non-comparative study
Aim is to determine safe dose ranges, immunogenicity, and local/systemic reactions


Phase 2 of clinical studies

100-300 study subjects
Looking at optimal dose/schedule in target population(s)
Usually controlled
Preliminary assessment of efficacy
Ongoing safety assessment


Phase 3 of clinical studies

1000 - > or equal to 3000 study subjects
Immunogenicity/efficacy in target populations
Ongoing safety assessment


Phase 4 of clinical studies

Done in the general population so the number of study subjects varies
Looking at "real world" effectiveness
Immunogenicity/efficacy in unstudied populations
Possible vaccine-vaccine interactions
Expanded safety assessment to look for rare or unexpected adverse events


3 principles of informed consent

Voluntary: must be able to consent or refuse without coercion or duress
Capacity: must understand the nature of the trial, the anticipated effect, and the alternatives to participation
Properly informed: fully aware of proposed study procedures and treatments, understand alternatives to participation, and understand the risks


2 reasons to register clinical trials

Understanding the potential benefits of a new treatment requires assessment of all clinical trials data
Failure to publish all trial data results in a body of published literature that may not reflect the true performance or safety of a new product in clinical trials


Publication bias

The tendency by authors and journals to be more likely to publish positive results