Fichas
Interventional study design
Fichas del conjunto (42)
- 1clinical trial, clinical study, experimental study, human study, investigational studyinterventional study designs
- 2natural studyobservational
- 3phase 0does it do what it should do?
exploratory, investigational new drug
asses drug target actions and pharmacokinetics
healthy volunteers
small number participants <20
very short duration - 4phase 1assess safety/tolerance and pharmacokinetics of one or more doses
healthy or disease volunteers depending on disease
small number of participants 20-80
short duration - 5phase 2assess effectiveness (continue to assess safety/tolerance, expands on phase one)
diseased volunteers
larger number of participants 100-300
short-to-medium duration - 6phase 3assess effectiveness (continue to assess safety/tolerability)
diseased volunteers
larger number of participants 500-3000 - 7Phase 4post FDA approval
assess long-term safety, effectiveness, optimal use (risk/benefits)
diseased volunteers
large population hundreds of thousands to millions
long duration - 8advantages of interventional trialscause precedes effect (can demonstrate causation)
only design-family used by FDA for approval process on label - 9disadvantages of interventional trialscost
complex/time consuming
ethical considerations (risk vs. benefit)
generalizability/external validity; is study population similar to general population and will methodology and findings be applicable to them
explicit, very detailed inclusion criteria - 10pragmatic trialshave greater flexibility in pt. selection
multiple diseases on multiple drugs
flexibility on what drugs to put them on based on their person. more variables
worry there is too much flexibility
gain more real life - 11Pragmatic trial disadvantagefix issue of being too restrictive (interventional)
but now maybe too much ability for confounding factors - 12Simple studyrandomizes/divides subject into 2 groups
1 randomization process only
used to test a single hypothesis - 13Factoraldivides/randomizes subjects into 2 or more groups and then further randomization in each of the groups into subgroups
used to test multiple hypothesis at the same time - 14Factoral benefitsimproves efficiency for answering clinical questions
increases study population sample size - 15Factoral disadvantagesincreases complexity which may be a barrier to recruitment
increases risk of drop outs
may restrict generalizability of results - 16parallel studygroups simultaneously and exclusively managed
no switching of intervention groups after initial randomization
(simple and factoral are also parallel) - 17Cross-over aka self-controlgroups serve as their own control by crossing over intervention after some time (washout time)
- 18cross-over/self control advantageallows for smaller sample sizes
no better comparison for a person than that same person - 19cross-over/self-control study disadvantagemuch longer than most studies
only suitable for long term conditions which are not curable
complex data analysis - 20composite outcomesmultiple endpoints combined into a single outcome
hospital or MI or HTN - 21secondary/tertiary studylesser importance yet still valuable
possible for future hypothesis generation - 22Primary outcomemost important, key outcomes
main research question used for developing/conducting the study - 23patient oriented endpointsnot focused on numbers, outcomes are interesting to participants in particular so they want to participate
- 24Non-random study designsubjects dont have an equal probability of being selected or assigned to each intervention group
convenience sampling
A-F 1st group G-M 2nd group etc...
except A names having a different confounder than the rest somehow - 25Random study groupmost commonly utilized
subjects do have an equal probability of being assigned to each intervention group - 26Randomization disadvantagesEquality of groups not guaranteed
flipping a quarter 10 times 8 might be head - 27Simple randomizationflipping a coin
equal probability - 28Blocked randomizationmake sure there are a specific number of patients per group. makes sure not all end up in one group
approaching 20 pt.s may allocate them to another smaller group - 29Stratified randomizationcomputer generated randomization into age groups or similar
but if 2 get put into one group for example, the rxer may put the next ones into the other group - 30Single blind studyDr.s know which group you are in
good for objective studies, only number data etc. - 31Double blindsubjective studies, interviewing etc.
no one knows what group they are in except one person - 32Open label/unmasked/unblindedsubjects and researchers know
- 33placebo/dummy therapytreatments look identical in every aspects
- 34placebo-effectimprovement in condition by power of suggestion
- 35Hawthorne-effectsubjects change behavior d/t being aware they are being studied
- 36post-hoc group analysisdata-dredging or fishing
is ok when planned for - 37Intension to treatinclude drop outs anyways
last known assessment used or carried forward into the study - 38intension to treat benefitspreserves randomization process
preserves baseline characeristics and group balance at baseline
maintains stats - 39per-protocolmust complete 80-90% of study to be considered in statistical data
- 40as treatedas switching occurs or changes (PCP gives them the drug being studied) adds them to stats in other group
- 41measuring drug levels pill counts at each visit bottle counter-topsassessing adherence/compliance
- 42frequent follow-up/visits treatment alarms/notification medication blister packs or dosage containersmethods of improving adherence/compliance
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- Epidemiology Fichas sobre Interventional study design, creado por Alexis Bartschi el 20/10/2017.
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- Alexis Bartschi
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