Issues in Generalizing Results from Clinical Trials

Steven Piantadosi ()
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Steven Piantadosi: Brigham and Women’s Hospital, Harvard Medical School, Department of Surgery, Division of Surgical Oncology

Chapter 113 in Principles and Practice of Clinical Trials, 2022, pp 2227-2240 from Springer

Abstract: Abstract Generalization is inference from the specific circumstances of a clinical trial to other settings or populations with the condition of interest. Accomplishing this is complex because trials are not population samples, methods supporting both internal and external validity must be assessed, the trial data must be fit for purpose, and relevant shared biology must be a foundation for extrapolation of results. In the context of the large-scale randomized evidence from the COVID-19 vaccine trials, this chapter discusses these issues and how generalizations might be enhanced. Laboratory experiments are a useful microcosm of the same issues and carry important lessons for this process.

Keywords: External validity; Generalizing results; Clinical trial analyses; Metadata; Data reduction; Biological similarity (search for similar items in EconPapers)
Date: 2022
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DOI: 10.1007/978-3-319-52636-2_236

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