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. 2021 Jul;17(20):2671-2681.
doi: 10.2217/fon-2021-0069. Epub 2021 Apr 21.

Quality of life assessment in renal cell carcinoma Phase II and III clinical trials published between 2010 and 2020: a systematic review

Alessandro Rizzo  1 , Veronica Mollica  1 , Filippo Gustavo Dall'Olio  1 , Angela Dalia Ricci  1 , Ilaria Maggio  2 , Andrea Marchetti  1 , Matteo Rosellini  1 , Matteo Santoni  3 , Andrea Ardizzoni  1 , Francesco Massari  1
Affiliations

Quality of life assessment in renal cell carcinoma Phase II and III clinical trials published between 2010 and 2020: a systematic review

Alessandro Rizzo et al. Future Oncol. 2021 Jul.

Abstract

Aims: Quality of life (QoL) assessment is frequently not included among the end points of clinical trials (CTs) on renal cell carcinoma. Herein we aimed to describe the assessment and reporting of QoL in Phase II and Phase III CTs published between 2010 and 2020. Methods: A total of 25 CTs were included; 76% of trials included were conducted in metastatic renal cell carcinoma patients, while 20% of studies evaluated adjuvant systemic treatments. Results: In 13/25 publications, QoL was not listed among the end points, with secondary publications dedicated to QoL present in a minority of cases. Conclusions: QoL was not included among the end points of a large percentage of CTs. Implementing the inclusion of QoL represents an urgent need.

Keywords: clinical trials; health-related quality of life; kidney cancer; quality of life questionnaire; randomized controlled trials; renal cell carcinoma.

Plain language summary

Lay abstract Recent years have seen growing attention toward quality of life (QoL) in medical oncology clinical trials and statistical measurement of this aspect of cancer treatment. Nonetheless, although most clinicians and researchers agree that QoL should represent a fundamental component of clinical trials, the inclusion of QoL results is still inadequate, and our systematic review confirms that implementing the inclusion of QoL remains an urgent need.

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