SISAQOL™ Training:

Standards for designing, analysing, interpreting, and presenting PRO data in cancer clinical trials

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Course features
  • Author: Name
  • Level: Advanced
  • Study time: X hours
  • Video time: X hours
  • Exams: X
Course overview
This e‑learning course provides an introduction to the SISAQOL™ international consensus recommendations for patient‑reported outcomes (PRO) and health‑related quality of life (HRQOL) in cancer clinical trials. Through expert-led presentations, the course guides participants through the core elements of the SISAQOL™ framework. Learners will become familiar with how to define PRO objectives, apply the estimand framework, describe key PRO concepts and endpoints, predefine and document strategies for handling intercurrent events and missing data, and ensure transparent, standardised, and reproducible reporting of PRO analyses for scientific, regulatory, and patient‑focused audiences.

What is included:

  • Clear and well‑defined PRO research objectives are essential—they must be aligned with the estimand framework to ensure appropriate design, analysis, and interpretation of PRO data. 
  • Handling intercurrent events (especially death) must be predefined and justified, as different strategies lead to different interpretations of treatment effects. 
  • Missing data and intercurrent events must be distinguished, with sensitivity and supplementary analyses required to ensure robust conclusions. 
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  • Repeated cross‑sectional or simple imputation methods are discouraged; longitudinal modelling and appropriate handling of uncertainty are recommended. 
  • Clinically meaningful change requires harmonized, fit‑for‑purpose thresholds, clearly differentiated for patient‑level and group‑level interpretation. 
  • Presentation of PRO results must follow consistent, transparent visual standards, including full scale ranges, directionality indicators, sample size reporting, and clear separation of confirmatory vs. exploratory findings. 

Course content

TEAM

Our faculty

Madeline Pe

Head of the Quality of Life Department at the EORTC 

Corneel Coens

Lead Statistician at the EORTC

Michael Schlichting

Director Biostatistics at Merck KGaA. Global

Prof. Saskia le Cessie

Medical Statistician 

Bernhard Holzner

Clinical Psychologist

Johannes M. Giesinger

Clinical Psychologist

Kristin Bjordal 

Professor

Beate Weiseler

Silene ten Seldam

Research Assistant 

Sjoukje Oosting

Cecilie D Amdal

Lisa Wintner