TABLE 7-1Considerations for Study Design Restrictions

DomainDefinition of Domain Terminology
Participant eligibility criteriaConsiderations include the intended treatment population of interest as identified by the study's authors.
Intervention flexibilityConsiderations include posology, dose, dosing interval, windows allowed for dosing; permitted concomitant treatments. The domain should be considered separately for experimental and comparisons treatment interventions.
Medical practice setting/practitioner expertiseConsiderations include experience, skills, and resources of the practitioner and the treatment team; the health care delivery system; standards of care at the site; and local cultural practices that may influence medical delivery or outcomes. The domain should be considered separately for experimental and comparisons treatment interventions.
Follow-up intensity and durationConsiderations include frequency and length of visits and the number and the scope of the assessments.
Outcome(s)Considerations include evaluation of measure(s) by which the interventions' effects are assessed and how well they reflect outcomes that are used and considered important to real-world practice.
Participant adherenceConsiderations include the degree to which the subjects are encouraged and tracked for adherence to study-related procedures.

SOURCES: Alphs presentation, July 17, 2018; Alphs and Bossie, 2016.

From: 7, How Tightly Should Investigators Attempt to Control or Restrict Treatment Quality in a Pragmatic or Real-World Trial?

Cover of Examining the Impact of Real-World Evidence on Medical Product Development
Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series.
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Forum on Drug Discovery, Development, and Translation; Shore C, Gee AW, Kahn B, et al., editors.
Washington (DC): National Academies Press (US); 2019 Feb 6.
Copyright 2019 by the National Academy of Sciences. All rights reserved.

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