The work of SISAQOL-IMI is split up into work packages. These are as follows:
Work package 1: The objective of WP 1 is to provide management governance, and coordination to the SISAQOL-IMI project consortium.
Work Package 2: The objective of WP 2 is to provide the methodological work to improve current 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.
Work Package 3: 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.
Work Package 4: 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.
Work Package 5: The objective of WP 5 is to independently validate the recommendations developed by the scientific working groups within the consortium.
Work Package 6: 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.
Work Package 7: WP 7 are responsible for developing international recommendations for the design, analysis, presentation and interpretation of PRO data for various stakeholders
Work Package 8: WP 8 work on patient engagement, dissemination strategies and educational programmes/workshops for the SISAQOL-IMI consortium.