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Clinical research associates experience with missing patient reported outcomes data in cancer randomized controlled trials

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Missing patient reported outcomes data threaten the validity of PRO‐specific findings and conclusions from randomized controlled trials by introducing bias due to data missing not at random. Clinical Research Associates… Click to show full abstract

Missing patient reported outcomes data threaten the validity of PRO‐specific findings and conclusions from randomized controlled trials by introducing bias due to data missing not at random. Clinical Research Associates are a largely unexplored source for informing understanding of potential causes of missing PRO data. The purpose of this qualitative research was to describe factors that influence missing PRO data, as revealed through the lived experience of CRAs.

Keywords: reported outcomes; research; randomized controlled; missing patient; outcomes data; patient reported

Journal Title: Cancer Medicine
Year Published: 2021

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