Ontology highlight
ABSTRACT:
SUBMITTER: Selker HP
PROVIDER: S-EPMC3904553 | biostudies-literature | 2014 Feb
REPOSITORIES: biostudies-literature
Selker H P HP Oye K A KA Eichler H-G HG Stockbridge N L NL Mehta C R CR Kaitin K I KI McElwee N E NE Honig P K PK Erban J K JK D'Agostino R B RB
Clinical pharmacology and therapeutics 20130923 2
We propose an "efficacy-to-effectiveness" (E2E) clinical trial design, in which an effectiveness trial would commence seamlessly upon completion of the efficacy trial. Efficacy trials use inclusion/exclusion criteria to produce relatively homogeneous samples of participants with the target condition, conducted in settings that foster adherence to rigorous clinical protocols. Effectiveness trials use inclusion/exclusion criteria that generate heterogeneous samples that are more similar to the gen ...[more]