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44 Cards in this Set
- Front
- Back
types of randomization
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1. blocking
2.stratification 3.adaptive randomization by covariates 4. adaptive randomization by response 5.play the winner (zelen) |
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randomization within strata
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stratification
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minimization of allocation
need to keep running total of balance by each factor assign next case to best balance simple randomization for ties *trying to keep covariates between groups as similar as possible |
adaptive randomization by covariates
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use coutcome data obtained during trial to influence allocation of patient to treatment
data driven assumes patient response known before next patient *goal is to allocate as few patients as possible to a seemingly inferior treatment |
adaptive randomization by response
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treatment assigned depends on previous patient outcome.
adv- more patients receive treatment disadv-investigator knows next assignment a. 1st subject- toss coin b. subsequent subjects are assigned previous treatment if sucessful, otherwise receive other treatment |
play the winner (zelen)
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what are the five parts to interim analysis
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1. recruitment rate
2.safety 3.outcomes consistent with expectations 4.treatment effects 5.futility of the trial |
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why is interim analysis done
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to periodically assess if it is likely that the clinical trial will actually answer the questions it was designed to answer
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what is the problem with multiple looks
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the more looks, the higher the false positive rate
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which phase of trial: information on chronic administration
postmarketing surveillance new treatment along with other conditions and treatments |
phase IV
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elements of a protocol
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1. schema
2. introduction 3.background/rationale 4.test a specific hypothesis 5.objectives- primary vs secondary 6. treament lan 7. potential tox and dose mod 8. data acquisition/submission 9.criteria for reponse, defn of endpoints |
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manual of operations
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step by step instructions for each procedures
detail specification of trial procuedure |
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types of measures for evaluation of patient response
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1.objective/factual
2. standardized measures 3.clinical assements 4. patient opinion 5.role of reading center |
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t/f: can randomize if there is a standard treatment
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FALSE. can randomize when there is NO standard treatment
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t/f: can randomize when standard treament has been shown to be no better than placeo
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TRUE
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T/F. can randomize with there effective treatment is not available to patients due to cost
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true
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t/f can randomize patients who respond well to standard therapy
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F. can randomize if patients refractory to standard treatment and when there is no standard second line treatment
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t/f. can randomize when testing add on treatment to standard treatment vs. standard treatment alone
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yup!
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t/f. can randomize when patients providing an informed refusal of standard therapy for minor condition for which many patients commonly refuse treatment
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true
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t/f. can randomize when standard therapy vs alternative therapy provide evidence that alternative therpay is at least as effective as standard therapy
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true
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t/f randomization occurs before eligiblity is determined and after the patient agrees to randomization
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FALSE. randomize only AFTER eligibity determien and patient agrees to be randomized.
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refers to the assignment of treatment to homogeneous groups defined by patient-relaed characteristics that may affect outcome
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stratification
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which one of these is not an advantage of stratification
1. keeps variability small 2.avoid imbalance in distribution of treatment groups within strata 3.increase efficiency 4.protect against Type l and type ll errors 5. increases confounding |
5. increases confounding. actually, one of the advantages of stratification is that in AVOIDS confounding
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two types of adaptive randomization
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1. covariate adjustment
2.reponse adjustment |
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who should be blinded
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patient
treatment team evaluator |
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why should patients be blinded
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patient expectations may introduce bias
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why should treatment team be blinded
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treatment team may be tempted to modify treatment as well as be biassed when evaluating the effects of outcome
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why should evaluator be blinded
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may introduce experimenter expectations which introduces bias
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refers to analyzing patients in the group that they have been randomized to independtly of what treatment they actually received
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intent to treat principal
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all NIH (gov't ) trials must be registered
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true
clinicaltrials.gove |
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used as a surrogate for hard to measure endpoints
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biomarkers
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adv. of biomarkers
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it is a quantitative measure which may give much higher power
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which phase of trial: provide evidence leading to a scientific basis for consideration of a chnge in health policy or standard of care
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phase III
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NIH requirments for DSMBs
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1.accrual
2.safety 3.statistics 4.fiding outside of trial |
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power and sample size is an optional part of any study? T/F
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FALSE power and sample size is an OBLIGATORY part of any study
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why pharmacogenetics
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because differing reponses to drug are due to genetic variation
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three type of pharmacogentic/biomarkers study design
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1.correlative
2. comparative 3. imbedded |
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correlative study objective
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exploratory or hypothesis testing/ association study
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this pharmo/biomarker study design is crossed with treament groups
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comparative study
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this pharmo/biomarker study design is added onto existing trial
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imbedded study
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The IRB is required for all human studies that receive_____?
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federal research funds
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components of informed consent
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1. purpose
2.procedure 3.heath/financial risks and benefits 4.confidentiality 5.alternatives 6. assent 7. conflict of interest 8.signature/witness |
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t/f. copies must have irb stamp but participants do not need a copy
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FALSE. copies of consent must have irb stamp and participants MUST be given a copy
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what is not an SAE
1.death 2.life threatening 3.hospitalization 4.disability 5.congenital anomaly 6.requires interventin to prevent permanent impairment or damage 7. none of the above |
NONE OF THE ABOVE
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when reporting SAEs. SAEs should be reported within ?? days and death should be reported??
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1. 5
2. immediatlely |