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.
Rizzo A., Mollica V., Dall'Olio F.G., Ricci A.D., Maggio I., Marchetti A., et al. (2021). Quality of life assessment in renal cell carcinoma Phase II and III clinical trials published between 2010 and 2020: A systematic review. FUTURE ONCOLOGY, 17(20), 2671-2681 [10.2217/fon-2021-0069].
Quality of life assessment in renal cell carcinoma Phase II and III clinical trials published between 2010 and 2020: A systematic review
Mollica V.;Dall'Olio F. G.;Ricci A. D.;Maggio I.;Marchetti A.;Rosellini M.;Santoni M.;Ardizzoni A.;Massari F.
2021
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
