Lecture 15-17 - Interventional Study Desings Flashcards Preview

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What main factors differentiate the different phases of interventional studies?

-population studied (healthy/diseased)
-sample size
-duration (can vary between diseases)


What precedes most interventional studies?

-preclinical studies performed in a lab on tissue or animals


What is characteristic of a phase 0 study?

-explanatory, new drug investigation

1. Assess drug-target actions and possibly pharmacokinetics in single or few doses
2. Healthy (possibly diseased) volunteers
3. Very small sample size
4. Very short duration


What is characteristic of a Phase 1 study?

1. Assess safety/tolerance and pharmacokinetics of one or more doses
2. Healthy or diseased
3. Small sample size
4. Short duration


What is characteristic of a phase 2 study?

1. Assess efficacy (continue to assess safety/tolerability)
2. Diseased volunteers
3. Larger sample size
4. Short-to-medium


What is characteristic of a phase 3 study?

1. Assess efficacy (continue to assess safety/tolerability)
2. Disease volunteer
-expansion of inclusion criteria and comparison groups
-different statistical-perspectives can be taken
3. Larger sample size
4. Longer duration


What is characteristic of a phase 4 study?

Post FDA-approval

1. Assess long term safety, effectiveness, and optimal use
2. Diseased volunteers
-expand use criteria (comorbidities/multidrug)
3. Large populations
4. Wide range of duration (years to ongoing)


What are the main advantages of interventional studies?

-they can demonstrate causation
-only process used for FDA approval


What is a simple design of interventional studies?

-single randomized division process
-commonly only answers a single research question


What is a factorial design for interventional studies?

-randomized division of subjects into groups followed by randomized subdivisions
-frequently used to answer more than one research question


What is a parallel design of interventional studies?

-groups simultaneously and exclusively managed
-individuals do not switch between interventional groups


What is a cross-over design of interventional studies?

-individuals switch between interventional groups
-each individual serves as their own control -> less people needed


What is a wash-out phase?

-a period where the individual is receiving no treatment before they are switched between interventional groups
-ensures that previous treatment has worn off before starting new treatment


What is a lead-in phase?

-occurs before intervention is began
-“practice” used to ensure that individuals can comply with study protocol
-can act as a wash-out for patients normal medications


The word “randomize” indicates what type of study?

-interventional (phase 0-4) study


What is the purpose of randomization?

-attempt to eliminate bias
-attempt to make groups as equal as possible
-can take into account confounders


What differentiates random and non-random group allocation?

-subjects have an equal chance of being assigned to each group or they don’t


What are the types of randomized allocation and what defines them?

-equal probability of getting into each group

-randomized allocation but ensures equal group sizes (at the end of a block of distribution you look at how many are in each group and possibly force allocate to underpopulated group)

-randomized allocation within strata of known confounders


What are the types of masking used in interventional studies and what defines them?

-study subjects do not know what interventional group they are in

-both investigators and study subjects don’t know what interventional group the subject is in

-both investigator and study subject know which interventional group the study subject is in