FIGURE 7-2. Decision aid on questions to consider regarding participant safety and investigator control of treatments in a trial taking place in a community care setting.

FIGURE 7-2Decision aid on questions to consider regarding participant safety and investigator control of treatments in a trial taking place in a community care setting

NOTE: This decision aid was drafted by some individual workshop participants based on the discussions of individual workshop participants at the first and second workshops in the real-world evidence series. The questions raised are those of the individual participants and do not necessarily represent the views of all workshop participants; the planning committee; or the National Academies of Sciences, Engineering, and Medicine, and the figure should not be construed as reflecting any group consensus.

SOURCE: Graff presentation, July 17, 2018.

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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