Chapter 4 Flashcards
Types of clinical studies without intervention (2) and with intervention
Case-control
Descriptive study
RCT
Non-RCT
Phase of clinical trial that elucidate mechanisms, assesses safety in the novel population, and post-marketing surveillance
Phase IV (postmarketing trial) features mechanistic or other support for an indication, to extend a previous indication to a new population, or to meet a new regulatory requirement
Phase of clinical trial designed to provide information on efficacy and safety for regulatory evaluation
Phase III, pivotal study
-require assessment of approvable endpoints
Phase of clinical trial designed to confirm biologic activity of the experimental therapy in patients with the disease of interest and, in some cases, to determine the likely optimal dose for both efficacy and tolerability.
Phase II
-use surrogate endpoints rather than clinical endpoints
Phase of the clinical trial that assesses the safety and tolerability in the first human experience of a novel therapy using healthy volunteers.
Phase I
Purpose of different phases of clinical trials:
I safety and biologic plausibility
II Efficacy- dose finding, adverse events, pathophysiologic insights
III designed to allow for regulatory approval
IV elucidate mechanism, assess safety in novel populations, post marketing surveillance
Clinical trial design in which patients are randomized to 2 or more groups and endpoints are compared between groups.
Parallel group design
Clinical trial design wherein patients receive one therapy for a period of time and then received placebo or another therapy.
Crossover trial, typically used for phase II studies
Clinical trial design that uses parallel group design wherein a patient population would be randomized to treatment A vs B, etc, leaving 4 distinct treatment groups
Factorial design
Study design to reject the null hypothesis
Superiority trial
This study design is used when it is necessary to show that a novel therapy is as good as an established therapy.
Noninferiority trial
