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Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life endpoints

Setting International Standards in Analyzing

Patient-Reported Outcomes and Quality of Life

endpoints

Work Packages

SISAQOL-IMI aims to develop international consensus recommendations for the design, analysis, interpretation, and presentation of PRO data in cancer clinical trials (CCTs). To reach this goal, SISAQOL-IMI is organized into five scientific work packages (WP 2, 3, 4, 5, 6), and 3 cross-cutting work packages (WP 1, 7, 8).

The objective of WP 1 is to provide management governance, and coordination to the SISAQOL-IMI project consortium.

Main objective

This WP will support the overall coordination of the scientific, operational, and administrative aspects of the project including administrative and financial management, compliance with scientific and ethical standards, compliance with general data protection regulations and communication with IMI. The EORTC infrastructure and its processes will serve as a framework for this project.

Sub-objectives

  1. To provide the needed methodological work to improve current scientific practice by determining consensus standards on the design, analysis, and interpretation of PRO data in cancer RCTs. This includes obtaining the patient perspectives and treatment outcomes that would result in meaningful treatment effect estimates.
  2. To identify and recommend similar principles meeting those set standards that can be applied to RCTs across various cancer indications in order to gain efficiency within cancer RCTs and to enhance comparability across cancer RCTs.
  3. To build on and continue the development of the initial SISAQOL-IMI work, particularly with attention to incorporation of the estimand framework.

The overall objective of WP 3 is to investigate the feasibility of, and develop recommendations for, the use of PRO measures for non-RCTs in cancer studies with a specific focus on single-arm studies.

The objective of WP 4 is the development of the recommendations for the graphical presentation of PRO findings from cancer clinical trials, including templates for graphs and tables for each objective identified in WP 2 and WP 3. These graphical presentation templates will create standards that promote interpretable and meaningful visualisation of PRO data from clinical trials.

The objective of WP 5 is to independently validate the recommendations developed by the scientific working groups within the consortium.

WP 6 is responsible for harmonising the terminologies and definitions related to clinically meaningful change in cancer clinical trials. This is important for patients as statistical significance does not always provide information on what is clinically relevant or meaningful for patients.

WP 7 are responsible for developing international recommendations for the design, analysis, presentation and interpretation of PRO data for various stakeholders

WP 8 work on patient engagement, dissemination strategies and educational programmes/workshops for the SISAQOL-IMI consortium

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