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25 Cards in this Set
- Front
- Back
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Strength of evidence (weak to strong)
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tradition, clinical experience, descriptive study, analytical study, RCT
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Pyramid of evidence (weak to strong)
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in vitro, comparative, ideas/consensus reports, single case reports, case series, case control study, cohort study, blinded RCT, meta-analysis, systematic review
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Clinical trial is a
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planned experiment in animals/humans to determine safety and efficacy of new drugs/treatments
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Clinical trials compare
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outcomes of group in new therapy vs. comparable group in control therapy
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Clinical trials evaluate new
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drugs, treatments, technologies, preventions, screening and diagnosis, methods of providing care, and health care policies
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Phase I
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test new drug on small group to evaluate safety, safe dosage range, SE
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Phase II
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larger group, evaluate effectiveness and safety
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Phase III (population study)
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large group, evaluate effectiveness, SE, compared to commonly used tx
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Phase IV (post-marketing study)
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continue testing, collect info about various populations and SE of long term use
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Basic clinical trial design
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question, population of interest, intervention, how efficacy will be assessed
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Clinical trial goals
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limited treatment groups (2), limited number of goals, null hypothesis + alternative hypothesis, quantify goal
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Experimental unit
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smallest independent grouping of elements that could receive a different treatment given the method of allocation
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Method of allocation
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preferably random and blind, simple random, stratified, blocks, cross-over
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Choice of control group
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existing drug, placebo, nothing
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Follow Up procedures
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double blind, intervention with treatment, evaluate extent of compliance and % withdrawal
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Measuring outcomes
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preferably clinically relevant, measured objectively and quantitatively, blind if subjective
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Statistical methods
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significance, power, difference in means (student’s t-test), difference in incidence and prevalence (RR, AP, chi-squared), life table
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P=
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probability of random error (type I), indicates statistically significant difference
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If different but not statistically significant
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need more power- repeat with more observations or perform meta-analysis
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Type I error
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declare a difference where none exists
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Type II error
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declare no difference where a meaningful one does exist (prevented with adequate sample size)
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Internal validity
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is conclusion supported by study design?
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External validity
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are results generalizable to reference population?
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Alternatives to clinical trials without comparison
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case report, case series
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Alternatives to clinical trials with comparison
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historical controls, epidemiological designs, database studies
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