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Oct 16, 2019 · Background Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice. In addition, the different types of impact associated with PRO trial results, their barriers and facilitators, and appropriate ...
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Oct 10, 2014 · For example, the following quote from the PRO Guidance explicitly endorses the functionality of electronic data collection platforms and, hence, implicitly endorses the shift to ePRO: “If a patient diary or some other form of unsupervised data entry is used, we plan to review the clinical trial protocol to determine what steps are taken to ...
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