What is SISAQOL-IMI?

SISAQOL-IMI (Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials – IMI) is an international multidisciplinary consortium, co-led by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI). SISAQOL-IMI will establish guidance on how to use patient-reported outcomes in cancer clinical trials so that they can be used in a methodologically sound way, analysed in a statistically adequate manner, and intelligibly presented to ensure a high study quality and a better comparability of results across clinical trials.

What is SISAQOL-IMI?

SISAQOL-IMI (Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials – IMI) is an international multidisciplinary consortium, co-led by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI). SISAQOL-IMI will establish guidance on how to use patient-reported outcomes in cancer clinical trials so that they can be used in a methodologically sound way, analysed in a statistically adequate manner, and intelligibly presented to ensure a high study quality and a better comparability of results across clinical trials.

What is SISAQOL-IMI?

SISAQOL-IMI (Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials – IMI) is an international multidisciplinary consortium, co-led by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI). SISAQOL-IMI will establish guidance on how to use patient-reported outcomes in cancer clinical trials so that they can be used in a methodologically sound way, analysed in a statistically adequate manner, and intelligibly presented to ensure a high study quality and a better comparability of results across clinical trials.

Who are we?

SISAQOL-IMI is a public-private collaborative research project under the Innovative Medicines Initiative (IMI). Forty-one stakeholder groups are involved in the partnership, including researchers from the pharmaceutical industry, academia, non-profit associations, cancer institutes, regulators, and patient advocacy organisations.

Who are we?

SISAQOL-IMI is a public-private collaborative research project under the Innovative Medicines Initiative (IMI). Forty-one stakeholder groups are involved in the partnership, including researchers from the pharmaceutical industry, academia, non-profit associations, cancer institutes, regulators, and patient advocacy organisations.

Who are we?

SISAQOL-IMI is a public-private collaborative research project under the Innovative Medicines Initiative (IMI). Forty-one stakeholder groups are involved in the partnership, including researchers from the pharmaceutical industry, academia, non-profit associations, cancer institutes, regulators, and patient advocacy organisations.

Analysis & outcomes

With patient-centered care gaining a more central role in oncology, patient-reported outcomes, such as health-related quality of life and symptoms, are increasingly being captured in cancer randomized controlled trials (RCTs) to provide valuable information on treatment risks, benefits and tolerability.

Diverse ways of analyzing, interpreting and reporting PRO data hinders comparability and credibility of results across trials. Subsequent inconsistencies in the results cause inefficient resource use, fragmented reporting, and interpretational barriers.

Analysis & outcomes

With patient-centered care gaining a more central role in oncology, patient-reported outcomes, such as health-related quality of life and symptoms, are increasingly being captured in cancer randomized controlled trials (RCTs) to provide valuable information on treatment risks, benefits and tolerability.

Diverse ways of analyzing, interpreting and reporting PRO data hinders comparability and credibility of results across trials. Subsequent inconsistencies in the results cause inefficient resource use, fragmented reporting, and interpretational barriers.

Goals of the project

The goal of the SISAQOL-IMI initiative is to create international recommendations on how to analyze PRO data in clinical trials. In order to be successful, these recommendations need to be supported by a broad consensus, balancing different needs and requirements.

It is hoped that these guidelines and tools would facilitate the analysis of PRO outcomes and would result in more reliable findings, improved interpretability and faster dissemination of data that stem from a higher quality use of statistical methods.

Goals of the project

The goal of the SISAQOL-IMI initiative is to create international recommendations on how to analyze PRO data in clinical trials. In order to be successful, these recommendations need to be supported by a broad consensus, balancing different needs and requirements.

It is hoped that these guidelines and tools would facilitate the analysis of PRO outcomes and would result in more reliable findings, improved interpretability and faster dissemination of data that stem from a higher quality use of statistical methods.

Goals of the project

The goal of the SISAQOL-IMI initiative is to create international recommendations on how to analyze PRO data in clinical trials. In order to be successful, these recommendations need to be supported by a broad consensus, balancing different needs and requirements.

It is hoped that these guidelines and tools would facilitate the analysis of PRO outcomes and would result in more reliable findings, improved interpretability and faster dissemination of data that stem from a higher quality use of statistical methods.

Work packages

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.

Work packages

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.

Work packages

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

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

Stakeholders

Stakeholders

SISAQOL Consortium

The Setting International Standards in Analysing Patient-Reported Outcomes and
Quality of Life Endpoints (SISAQOL) Consortium was convened by the EORTC in 2016,
and has started engaging various international stakeholders (regulators, health
technology assessment bodies, payers, clinicians, methodological and applied
statisticians, PRO experts, and patient representatives) to address issues on the lack
of standards in the evaluation of PRO findings in cancer randomized controlled trials.

These various ways of evaluating PRO data may lead to erroneous and inconsistent
decisions from different stakeholders, which may adversely impact patient care and
outcomes.

The Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints (SISAQOL) Consortium was convened by the EORTC in 2016, and has started engaging various international stakeholders (regulators, health technology assessment bodies, payers, clinicians, methodological and applied statisticians, PRO experts, and patient representatives) to address issues on the lack of standards in the evaluation of PRO findings in cancer randomized controlled trials.

These various ways of evaluating PRO data may lead to erroneous and inconsistent decisions from different stakeholders, which may adversely impact patient care and outcomes.

The Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints (SISAQOL) Consortium was convened by the EORTC in 2016, and has started engaging various international stakeholders (regulators, health technology assessment bodies, payers, clinicians, methodological and applied statisticians, PRO experts, and patient representatives) to address issues on the lack of standards in the evaluation of PRO findings in cancer randomized controlled trials.

These various ways of evaluating PRO data may lead to erroneous and inconsistent decisions from different stakeholders, which may adversely impact patient care and outcomes.

The SISAQOL-IMI Consortium will build on the previous work of the SISAQOL
Consortium by further broadening the engagement of stakeholder groups,
harmonising available recommendations, and updating them based on
stakeholder needs and recent developments in the methodological literature.
To learn more about the work of the SISAQOL-Consortium, see the links below.

The SISAQOL-IMI Consortium will build on the previous work of the SISAQOL Consortium by further broadening the engagement of stakeholder groups, harmonising available recommendations, and updating them based on stakeholder needs and recent developments in the methodological literature.
To learn more about the work of the SISAQOL-Consortium, see the links below.

The SISAQOL-IMI Consortium will build on the previous work of the SISAQOL  Consortium by further broadening the engagement of stakeholder groups, harmonising available recommendations, and updating them based on stakeholder needs and recent developments in the methodological literature.
To learn more about the work of the SISAQOL-Consortium, see the links below.

Access the interactive tool
Access the list of publications

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Want to know more
about SISAQOL-IMI?

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