Patient-reported outcomes in ovarian cancer clinical trials

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Patient-reported outcomes in ovarian cancer clinical trials.

There is general acceptance of the importance of incorporating patient-reported outcome (PRO) measures including health-related quality of life (HRQOL) into clinical trials, and there are now a number of guidance documents available on how to use PRO's for regulatory authorities and in comparative effectiveness research. The methods used to collect, analyse and report PRO data in clinical trial...

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OBJECTIVES Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group...

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Every cancer treatment, irrespective of its clinical effectiveness, has an impact on patients' quality of life (QoL). Even recently developed targeted therapies might have side effects and significantly impact patients' QoL. Thus, understanding the advantages and disadvantages of different treatments from the patient's standpoint has become a must in clinical research and is highly valued by ma...

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With increasing limits on the resources available to conduct cancer clinical trials, the inclusion of patient-reported outcomes (PROs) in treatment and symptom management trials must be prioritized. Although it has been suggested on occasion that phase III trials should take precedence over phase II trials, we argue that there is a clear and important role for PRO assessment in phase II trials ...

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ژورنال

عنوان ژورنال: Annals of Oncology

سال: 2013

ISSN: 0923-7534

DOI: 10.1093/annonc/mdt474