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Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures.

Publication ,  Journal Article
Pe, M; Alanya, A; Falk, RS; Amdal, CD; Bjordal, K; Chang, J; Cislo, P; Coens, C; Dirven, L; Speck, RM; Fitzgerald, K; Galinsky, J; Holzner, B ...
Published in: Lancet Oncol
June 2023

Patient-reported outcomes (PROs), such as symptoms, functioning, and other health-related quality-of-life concepts are gaining a more prominent role in the benefit-risk assessment of cancer therapies. However, varying ways of analysing, presenting, and interpreting PRO data could lead to erroneous and inconsistent decisions on the part of stakeholders, adversely affecting patient care and outcomes. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) Consortium builds on the existing SISAQOL work to establish recommendations on design, analysis, presentation, and interpretation for PRO data in cancer clinical trials, with an expanded set of topics, including more in-depth recommendations for randomised controlled trials and single-arm studies, and for defining clinically meaningful change. This Policy Review presents international stakeholder views on the need for SISAQOL-IMI, the agreed on and prioritised set of PRO objectives, and a roadmap to ensure that international consensus recommendations are achieved.

Duke Scholars

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Published In

Lancet Oncol

DOI

EISSN

1474-5488

Publication Date

June 2023

Volume

24

Issue

6

Start / End Page

e270 / e283

Location

England

Related Subject Headings

  • Quality of Life
  • Patient Reported Outcome Measures
  • Oncology & Carcinogenesis
  • Neoplasms
  • Humans
  • Consensus
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
 

Citation

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Chicago
ICMJE
MLA
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Pe, M., Alanya, A., Falk, R. S., Amdal, C. D., Bjordal, K., Chang, J., … SISAQOL-IMI Consortium, . (2023). Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures. Lancet Oncol, 24(6), e270–e283. https://doi.org/10.1016/S1470-2045(23)00157-2
Pe, Madeline, Ahu Alanya, Ragnhild Sorum Falk, Cecilie Delphin Amdal, Kristin Bjordal, Jane Chang, Paul Cislo, et al. “Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures.Lancet Oncol 24, no. 6 (June 2023): e270–83. https://doi.org/10.1016/S1470-2045(23)00157-2.
Pe M, Alanya A, Falk RS, Amdal CD, Bjordal K, Chang J, Cislo P, Coens C, Dirven L, Speck RM, Fitzgerald K, Galinsky J, Giesinger JM, Holzner B, Le Cessie S, O’Connor D, Oliver K, Pawar V, Quinten C, Schlichting M, Ren J, Roychoudhury S, Taphoorn MJB, Velikova G, Wintner LM, Griebsch I, Bottomley A, SISAQOL-IMI Consortium. Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures. Lancet Oncol. 2023 Jun;24(6):e270–e283.
Journal cover image

Published In

Lancet Oncol

DOI

EISSN

1474-5488

Publication Date

June 2023

Volume

24

Issue

6

Start / End Page

e270 / e283

Location

England

Related Subject Headings

  • Quality of Life
  • Patient Reported Outcome Measures
  • Oncology & Carcinogenesis
  • Neoplasms
  • Humans
  • Consensus
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis