Interventional Study Design 2 Flashcards
Define study population
Subset of the population with the condition or characteristics of interest defined by the eligibility criteria
Study population considerations
Feasibility Anticipated effects Generalizability Risk/benefits Disease/pt characteristics
Define inclusion criteria
Factors which allow potential subjects to be included in the study
Precisely specified and defined
Characteristics, diagnostic criteria, disease state
Inclusion Criteria Determinants
Select those who might benefit
Those who you can detect the effect
Define exclusion criteria
Factors which allow potential subjects to be excluded from enrolling
Age, gender, stage, underlying disease, previous treatment, unacceptable risk, inability to perform necessary assessments
Exclusion Factor Determinants
High risk of AE
Competing risks
Types of variables
Predictor (Independent) variables
Outcome (dependent) variables
Confounding variables
Independent variables
Usually manipulated by the investigator (treatment or status)
Presumed to be the causes and should predict the outcome
Dependent variables
Outcome or effect that is measured (study endpoint)
Depends on independent variable
Define Primary endpoints
Improvement in overall survival
Define Secondary endpoints
Progression free survival
Define Definitive
Clinically meaningful
Define Surrogate
Measure that may be predictive of the clinically meaningful outcome
Define Composite endpoint
A combo of multiple endpoints
Valid surrogate endpoint must:
Correlate with outcome of interest Accurately predict outcome of interest Capture treatment effect Pro: easier and faster than definitive Cons: Cannot account for unknown aspects
