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). The consortium has been convened to generate recommendations to standardize the use, analysis, and interpretation of patient reported outcome (PRO) data in cancer clinical trials. 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.

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). The consortium has been convened to generate recommendations to standardize the use, analysis, and interpretation of patient reported outcome (PRO) data in cancer clinical trials. 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.

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). The consortium has been convened to generate recommendations to standardize the use, analysis, and interpretation of patient reported outcome (PRO) data in cancer clinical trials. 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.

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

Measures of health-related quality of life (HRQoL) and other patient-reported outcomes (PRO) generate important data in cancer randomized controlled trials (RCTs) to assist in evaluating the risks and benefits of cancer therapies, and fostering patient-centered cancer care.

However, the various ways these measures are analyzed and interpreted make it difficult to compare results across trials. This hinders the application of research findings to inform publications, product labelling, clinical guidelines and health policy.

To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL-IMI) initiative was established.

This international multidisciplinary consortium, convened by the European Organisation for Research and Treatment of Cancer (EORTC) 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.

SISAQOL-IMI kicked off at the beginning of January and will run for four years.

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

Measures of health-related quality of life (HRQoL) and other patient-reported outcomes (PRO) generate important data in cancer randomized controlled trials (RCTs) to assist in evaluating the risks and benefits of cancer therapies, and fostering patient-centered cancer care.

However, the various ways these measures are analyzed and interpreted make it difficult to compare results across trials. This hinders the application of research findings to inform publications, product labelling, clinical guidelines and health policy.

To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL-IMI) initiative was established.

This international multidisciplinary consortium, convened by the European Organisation for Research and Treatment of Cancer (EORTC) 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.

SISAQOL-IMI kicked off at the beginning of January and will run for four years.

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

Measures of health-related quality of life (HRQoL) and other patient-reported outcomes (PRO) generate important data in cancer randomized controlled trials (RCTs) to assist in evaluating the risks and benefits of cancer therapies, and fostering patient-centered cancer care.

However, the various ways these measures are analyzed and interpreted make it difficult to compare results across trials. This hinders the application of research findings to inform publications, product labelling, clinical guidelines and health policy.

To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL-IMI) initiative was established.

This international multidisciplinary consortium, convened by the European Organisation for Research and Treatment of Cancer (EORTC) 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.

SISAQOL-IMI kicked off at the beginning of January and will run for four years.

Public – private collaborative research

The SISAQOL-IMI consortium is comprised of leading researchers and statisticians, key individuals from various international oncologic and medical societies, advisory and regulatory bodies, academic societies, pharmaceutical industry, cancer institutes and crucially patient advocacy organizations (represented by the Workgroup for European Cancer Patient Advocacy Networks and led by Myeloma Patients Europe) – with 41 stakeholder groups involved in the project.

This project and its generated recommendations will be of critical importance to organisations like the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), as PRO data presented uniformly across trials and cancers will help support fair and informed decision making. Robust and meaningful PRO data may also lead to improved shared decision-making between patients and their treating physicians. This in turn may lead to improved patient satisfaction, an increased likelihood of adherence to treatment, higher likelihood of treatment success, and a reduction in health-care cost.

Public – private collaborative research

The SISAQOL-IMI consortium is comprised of leading researchers and statisticians, key individuals from various international oncologic and medical societies, advisory and regulatory bodies, academic societies, pharmaceutical industry, cancer institutes and crucially patient advocacy organizations (represented by the Workgroup for European Cancer Patient Advocacy Networks and led by Myeloma Patients Europe) – with 41 stakeholder groups involved in the project.

This project and its generated recommendations will be of critical importance to organisations like the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), as PRO data presented uniformly across trials and cancers will help support fair and informed decision making. Robust and meaningful PRO data may also lead to improved shared decision-making between patients and their treating physicians. This in turn may lead to improved patient satisfaction, an increased likelihood of adherence to treatment, higher likelihood of treatment success, and a reduction in health-care cost.

Public – private collaborative research

The SISAQOL-IMI consortium is comprised of leading researchers and statisticians, key individuals from various international oncologic and medical societies, advisory and regulatory bodies, academic societies, pharmaceutical industry, cancer institutes and crucially patient advocacy organizations (represented by the Workgroup for European Cancer Patient Advocacy Networks and led by Myeloma Patients Europe) – with 41 stakeholder groups involved in the project.

This project and its generated recommendations will be of critical importance to organisations like the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), as PRO data presented uniformly across trials and cancers will help support fair and informed decision making. Robust and meaningful PRO data may also lead to improved shared decision-making between patients and their treating physicians. This in turn may lead to improved patient satisfaction, an increased likelihood of adherence to treatment, higher likelihood of treatment success, and a reduction in health-care cost.

Project Outcomes

This four year collaborative project will develop a set of standards for the design, analysis, interpretation, and presentation of Patient Reported Outcome (PRO) data for cancer clinical trials. Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials.

Watch more here

Project Outcomes

This four year collaborative project will develop a set of standards for the design, analysis, interpretation, and presentation of Patient Reported Outcome (PRO) data for cancer clinical trials. Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials.

Watch more here

SISAQOL IMI | Abigirl Machingura

SISAQOL IMI | Karen Keating

SISAQOL IMI | Claire Snyder and Michael Brundage

SISAQOL IMI | Abigirl Machingura

SISAQOL IMI | Karen Keating

SISAQOL IMI | Claire Snyder and Michael Brundage

Project Outcomes

This four year collaborative project will develop a set of standards for the design, analysis, interpretation, and presentation of Patient Reported Outcome (PRO) data for cancer clinical trials. Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials.

Watch more here

SISAQOL IMI | Abigirl Machingura

SISAQOL IMI | Karen Keating

SISAQOL IMI | Claire Snyder and Michael Brundage