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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

by Gerlinger, Christoph , Cruz Rivera, Samantha , Keating, Karen , Tschuggnall, Michael , Bhatnagar, Vishal , Kiesewetter, Barbara , Boele, Florien , Gilbert, Alexandra , Van Lancker, Kelly , Frigolett Catalan, Cristián , Horodniceanu, Erica , Ge, Miaomiao , Wolf, Birgit , Arraras, Juan , Coons, Stephen Joel , Cappelleri, Joseph , Roychoudhury, Satrajit , Dafni, Ourania , Sail, Kavita , Barbachano, Yolanda , Emechebe, Nnadozie , Regnault, Antoine , Sasseville, Maxime , Thomas, Stefanie , Voorhaar, Maarten , Brundage, Michael , Bottomley, Andrew , Kuljanic, Karin , Eremenco, Sonya , Snyder, Claire , Shelley Wang, Xin , Sen, Rohini , Garin, Olatz , Schürmann, Christoph , Gross, Franziska , Peil, Barbara , Peacock, Rosemary , Giesinger, Johannes M , Cleeland, Charlie , Pawar, Vivek , Cislo, Paul , Taphoorn, Martin J B , Fiero, Mallorie , De Vries, Corinne , Sauerbrei, Willi , Rodriguez, Lisa , Johnson, Laura Lee , Ren, Jinma , Quinten, Chantal , Dekanic Arbanas, Gracia , Petersen, Morten , Turner, Sean C , Terada, Mitsumi , Galinsky, Jayne , O'Connor, Daniel , Machingura, Abigirl , Roitberg, Felipe , Verbeke, Geert , Schoepf, Felix , Kluetz, Paul , Vilagut, Gemma , Thoma

in Cancer / Cancer therapies / Clinical outcomes / Clinical trials / Consensus / Consortia / Data analysis / Data collection / Decision making / Hematology, Oncology, and Palliative Medicine / Humans / International standards / Neoplasms - drug therapy / Patient Reported Outcome Measures / Patients / Quality of Life / Risk assessment / Stakeholders

2023

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Journal Article

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

Gerlinger, Christoph,

Cruz Rivera, Samantha,

Keating, Karen,

Tschuggnall, Michael,

Bhatnagar, Vishal,

Kiesewetter, Barbara,

Boele, Florien,

Gilbert, Alexandra,

Van Lancker, Kelly,

Frigolett Catalan, Cristián,

Horodniceanu, Erica,

Ge, Miaomiao,

Wolf, Birgit,

Arraras, Juan,

Coons, Stephen Joel,

Cappelleri, Joseph,

Roychoudhury, Satrajit,

Dafni, Ourania,

Sail, Kavita,

Barbachano, Yolanda,

Emechebe, Nnadozie,

Regnault, Antoine,

Sasseville, Maxime,

Thomas, Stefanie,

Voorhaar, Maarten,

Brundage, Michael,

Bottomley, Andrew,

Kuljanic, Karin,

Eremenco, Sonya,

Snyder, Claire,

Shelley Wang, Xin,

Sen, Rohini,

Garin, Olatz,

Schürmann, Christoph,

Gross, Franziska,

Peil, Barbara,

Peacock, Rosemary,

Giesinger, Johannes M,

Cleeland, Charlie,

Pawar, Vivek,

Cislo, Paul,

Taphoorn, Martin J B,

Fiero, Mallorie,

De Vries, Corinne,

Sauerbrei, Willi,

Rodriguez, Lisa,

Johnson, Laura Lee,

Ren, Jinma,

Quinten, Chantal,

Dekanic Arbanas, Gracia,

Petersen, Morten,

Turner, Sean C,

Terada, Mitsumi,

Galinsky, Jayne,

O'Connor, Daniel,

Machingura, Abigirl,

Roitberg, Felipe,

Verbeke, Geert,

Schoepf, Felix,

Kluetz, Paul,

Vilagut, Gemma,

Thoma

2023

Overview

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.

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Elsevier Ltd,Elsevier Limited

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