Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials

Andrew Bottomley, Madeline Pe, Jeff Sloan, Ethan Basch, Franck Bonnetain, Melanie Calvert, Alicyn Campbell, Charles Cleeland, Kim Cocks, Laurence Collette, Amylou C. Dueck, Nancy Devlin, Hans Henning Flechtner, Carolyn Gotay, Eva Greimel, Ingolf Griebsch, Mogens Groenvold, Jean Francois Hamel, Madeleine King, Paul G. KluetzMichael Koller, Daniel C. Malone, Francesca Martinelli, Sandra A. Mitchell, Carol M. Moinpour, Jammbe Z. Musoro, Daniel O’Connor, Kathy Oliver, Elisabeth Piault-Louis, Martine Piccart, Francisco L. Pimentel, Chantal Quinten, Jaap C. Reijneveld, Christoph Schürmann, Ashley Wilder Smith, Katherine M. Soltys, Rajeshwari Sridhara, Martin J.B. Taphoorn, Galina Velikova, Corneel Coens

Research output: Contribution to journalArticlepeer-review

40 Scopus citations


Background: There is currently a lack of consensus on how health-related quality of life and other patient-reported outcome measures in cancer randomized clinical trials are analyzed and interpreted. This makes it difficult to compare results across randomized controlled trials (RCTs) synthesize scientific research, and use that evidence to inform product labeling, clinical guidelines, and health policy. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials (SISAQOL) Consortium aims to develop guidelines and recommendations to standardize analyses of patient-reported outcome data in cancer RCTs. Methods and Results: Members from the SISAQOL Consortium met in January 2017 to discuss relevant issues. Data from systematic reviews of the current state of published research in patient-reported outcomes in cancer RCTs indicated a lack of clear reporting of research hypothesis and analytic strategies, and inconsistency in definitions of terms, including “missing data,”“health-related quality of life,” and “patient-reported outcome.” Based on the meeting proceedings, the Consortium will focus on three key priorities in the coming year: developing a taxonomy of research objectives, identifying appropriate statistical methods to analyze patient-reported outcome data, and determining best practices to evaluate and deal with missing data. Conclusion: The quality of the Consortium guidelines and recommendations are informed and enhanced by the broad Consortium membership which includes regulators, patients, clinicians, and academics.

Original languageEnglish (US)
Pages (from-to)624-630
Number of pages7
JournalClinical Trials
Issue number6
StatePublished - Dec 1 2018


  • Guidelines
  • cancer clinical trials
  • health-related quality of life
  • patient-reported outcomes
  • standards

ASJC Scopus subject areas

  • Pharmacology


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