38 open-label study bias

› view › bias-patient-reportedBias for Patient-Reported Outcomes in Open-Label Cancer ... Feb 28, 2019 · A common concern with patient-reported outcomes (PROs) in open-label trials is that a patient’s knowledge of treatment received could influence their view and reporting of their symptoms. With this in mind, members of the US Food and Drug Administration explored the possibility of such bias in a recent viewpoint published in JAMA Oncology. “In light of the anticipated growth in PRO submissions to the FDA,” the authors reasoned, “we outline our thoughts on the ways in which open label ...

Open-label study bias

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