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News2021-06-22T13:02:04+00:00

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Second SISAQOL-IMI Consensus Meeting

16 and 17 March 2022

On 16 and 17 March, the SISAQOL-IMI consortium will convene virtually for a second consensus meeting involving all 41 members.

SISAQOL-IMI aims to generate international recommendations on how to analyse, interpret and present patient reported outcome (PRO) data collected in cancer clinical trials. A primary aim is that the recommendations generated in SISAQOL-IMI will be agreed through consensus and used by all stakeholders involved PRO data analysis to ensure consistency and improve patient-centred treatment and care. You can read more about consortium goals here.

About the consensus meeting

The SISAQOL-IMI consensus meeting will help stakeholders discuss, debate and agree the recommendations generated so far via literature reviews. These recommendations are on the following topics:

  • The design, analysis and interpretation of PRO data in cancer randomized controlled trials (RCT) – work package 2
  • The use of PRO measures for single arm trials – work package 3
  • Terminologies and definitions related to clinically meaningful change in cancer clinical trials – work package 6

During the consensus meeting, 47 recommendation “statements” will be discussed, debated and voted by a representative from each of the 41 SISAQOL-IMI stakeholder groups.

Any disagreements raised on day one will be addressed and aimed to be resolved on day two. By the end of the consensus process, it is hoped that the consortium will have a series of recommendations to take forward.

Next steps

Following the consensus meeting, the next steps will be to create a detailed technical document including the statements and how to implement them. The technical document will be supported by a layperson version that will be interpretable for patients and the general public.

Further consensus meetings are planned in the coming years to agree recommendations generated from other SISAQOL-IMI work packages.

If you have any questions about the meeting or SISAQOL-IMI please contact us.

SISAQOL-IMI Projekt: Internationale Standards für die Integration der Patientenperspektive in onkologische Studien

27th May 2021

Knapp 6 Millionen Euro investieren die Innovative Medicine Initiative (IMI) der EU und die European Federation of Pharmaceutical Industries and Associations (EFPIA) in die Einbindung patientenberichteter Daten (PROs) in klinische Krebsstudien. Neu entwickelte internationale Standards werden den einheitlichen Einsatz von PROs in der Forschung fördern und damit den klinischen Alltag positiv beeinflussen. Experten der Medizin Uni Innsbruck und deren Teams sind federführend beteiligt.

Die Beurteilung der Krankheitsfolgen und Behandlungseffekte direkt durch die betroffenen PatientInnen mithilfe von PRO-Instrumenten liefert wichtige Informationen für die onkologische Forschung und Therapie. Beginnend mit 2016 hat es sich das SISAQOL (Setting International Standards of Patient-Reported Outcomes and Quality of Life) Konsortium zur Aufgabe gemacht, die bisher uneinheitliche Verwendungspraxis von PROs in klinischen onkologischen Studien mit strukturierten Empfehlungen zu harmonisieren. Nach ersten Erfolgen hinsichtlich der Definition einzelner Studienendpunkte und deren statistischer Analyse, wurde das Konsortium 2019 erweitert und nachdem sich SISAQOL-IMI im zweistufigen Antragsprozess eines IMI Förderaufrufs durchsetzen konnte, startete das Projekt offiziell mit 01. Januar 2021.

Internationale ExpertInnen entwickeln einheitliche Standards

Unter der Leitung der European Organisation for Research and Treatment of Cancer (EORTC) – einer gemeinnützigen Organisation für Studien zur Krebstherapie mit Sitz in Brüssel ­- und dem Pharmaunternehmen Boehringer Ingelheim arbeiten in dem internationalen, multidisziplinären SISAQOL-IMI-Konsortium 41 sowohl öffentliche als auch private Organisationen zusammen. ForscherInnen und ExpertInnen aus akademischen Institutionen, medizinischen Einrichtungen, gemeinnützigen Vereinen, Patientenvertretungsorganisationen, Zulassungsbehörden, Klein- und mittelständischen Unternehmen sowie aus der pharmazeutischen Industrie machen es sich zur Aufgabe, wissenschaftliche Methoden bei der Verwendung von PRO-Instrumenten und -Daten in der onkologischen Forschung auf einen Nenner zu bringen. Im Speziellen bedeutet das, dass diese Standards ForscherInnen dabei anleiten werden PRO-Studienendpunkte optimal zu definieren, zu erheben, detailliert zu analysieren, sowie die Ergebnisse verständlich grafisch aufzubereiten.

Innsbruck prominent im SISAQOL-IMI-Konsortium vertreten

Gleich zwei der acht Schwerpunkte des SISAQOL-IMI-Projektes werden an der Universitätsklinik für Psychiatrie II von langjährig im Bereich der PRO- und Lebensqualitätsforschung tätigen Psychologen geleitet. Sowohl Bernhard Holzner, als auch Johannes M. Giesinger zeichnen sich für die Umsetzung je eines Arbeitspaketes verantwortlich. Die Koordination dieser Arbeitspakete wird von Lisa M. Wintner und Micha Pilz unterstützt. Im Sinne der gemeinsamen Projektdurchführung durch öffentliche Organisationen und private Unternehmen, erfolgt die Leitung der Arbeitspakete jeweils gemeinsam mit Jane Chang bzw. Carla Mamolo vom Pharmaunternehmen Pfizer Inc.

Das Arbeitspaket von Bernhard Holzner erstellt Empfehlungen für die zielgruppenorientierte, grafische Darstellung von PRO-Daten aus klinischen Studien. „Mittels definierter Vorlagen soll es über verschiedene Studien hinweg ermöglicht werden, Patient-Reported Outcome-Daten aus der Onkologie verständlich und informativ aufzubereiten und zu präsentieren“, sagt Holzner. Davon profitiere die Vergleichbarkeit von Studienergebnissen sowie deren Potenzial, in der klinischen Routine handlungs- und entscheidungsleitend zu sein.

Johannes M. Giesinger entwickelt in seinem Arbeitspaket Richtlinien, mit deren Hilfe klinisch relevante Unterschiede in PROs zwischen verschiedenen Behandlungsgruppen in klinisch-onkologischen Studien bestimmt werden sollen. Die Beurteilung des klinischen Nutzens aber auch der negativen Auswirkungen einer Behandlung wird so maßgeblich erleichtert. „Die Perspektive der Patientinnen und Patienten erhält dadurch stärkeres Gewicht“, betont Giesinger.

Vier arbeitsreiche Jahre im Zeichen der Konsensfindung

Die Zusammenarbeit der Schwerpunkte innerhalb von SISAQOL-IMI ist sehr eng, da die Arbeitspakete vielschichtig miteinander verknüpft sind. Folglich gilt es nicht nur den eigenen Bereich voranzutreiben, sondern sich thematisch auch in den anderen Arbeitsgruppen zu engagieren. Das erfolgt auf verschiedenen Ebenen mittels interner Reviews, Kommentarrunden und größeren Meetings zur Konsensfindung. „Die Meinung von über 200 VertreterInnen des Konsortiums auf einen Nenner zu bringen, wird nicht einfach sein.“, sind sich Holzner, wie auch Giesinger sicher. Das große gemeinsame Ziel, die Qualität zukünftiger klinischer PRO-Forschung zu verbessern und zu sichern, sei allerdings auch ein großer Motivator. Neben der Entwicklung der Standards wird zudem eine erste Validierung der erarbeiteten Empfehlungen im Rahmen von SISAQOL-IMI geleistet, dessen Ergebnisse am Ende der vierjährigen Projektlaufzeit, Ende 2024, verfügbar sein werden.

Hintergrund

Die Innovative Medicines Initiative (IMI) ist Europas größte öffentlich-private Forschungsinitiative mit dem Ziel, die Entwicklung innovativer Medikamente und den Zugang der Patienten zu diesen Medikamenten zu beschleunigen, insbesondere in Bereichen, in denen ein ungedeckter medizinischer oder sozialer Bedarf besteht. Die Initiative unterstützt gemeinschaftliche Forschungsprojekte und baut Netzwerke von industriellen und akademischen Experten auf, um die pharmazeutische Innovation in Europa zu fördern.

(27.05.2021, Text: T. Mair, Foto: MUI/David Bullock)

Links:

SISAQOL-IMI Projekt;
https://www.imi.europa.eu/projects-results/project-factsheets/sisaqol-imi
https://event.eortc.org/sisaqol/

Patient Reported Outcomes an der Universitätsklinik für Psychiatrie II, Innsbruck
https://psychosomatik.tirol-kliniken.at/page.cfm?vpath=forschung/-patient-reported-outcomes

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Collaborating for consensus: Standardizing the design, analysis and interpretation of patient-reported outcomes in cancer clinical trials

12th April 2021

Patient-reported outcomes, or PROs, are important considerations when new cancer therapies are being investigated, including in benefit and risk assessments. PROs include how patients themselves experience and report their symptoms, as well as other health-related quality of life (HRQOL) issues.

The importance of patient involvement in the development of cancer therapies must not be underestimated if we are to truly transform the lives of people living with cancer.

Over the past few years, we have seen an increase in the collection of PROs in cancer clinical trials. However, to date, a set of robust, international recommendations to standardize the design, analysis, presentation and interpretation of these data has been lacking. Individual researchers and organizations currently have their own standards, which can lead to varying conclusions being drawn from the same trials, and different decisions being made across stakeholders. Ultimately, this lack of consistency could negatively impact patient care and outcomes.

Launching SISAQOL-IMI

The SISAQOL (Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials) Consortium was first convened by the European Organisation for Research and Treatment of Cancer (EORTC) in 2016, to engage a range of international stakeholders to address the issues of inconsistency in using PRO data.

In February this year, the launch of SISAQOL-IMI was announced – a four-year project with the ambition of improving how PROs are used in cancer clinical trials. Co-led by my colleagues and I at Boehringer Ingelheim as the Project Lead, and the EORTC as the Project Coordinator, SISAQOL-IMI will develop a consensus-based set of best practice recommendations for the design, analysis and interpretation of PRO endpoints in cancer clinical trials. This will be done with the view that some of these findings may also be relevant to other therapeutic areas.

The launch of this project signifies the SISAQOL Consortium responding to the Innovative Medicines Initiative’s (IMI) call to broaden stakeholder engagement work, harmonize available recommendations, and update them based on stakeholder needs and recent developments in the methodological literature.

SISAQOL-IMI’s ambition is to create recommendations that:

·        address the interests and needs of a broad range of international stakeholders, based on a consensus among them,

·        are of acceptable and high methodological quality, and

·        are able to be interpreted by stakeholders both with and without statistical backgrounds, including lay people.

Although there have been other large-scale initiatives of this nature in the past, we have rarely seen any other broad, global and multi-stakeholder outreach projects on the same scale as SISAQOL-IMI. This is one of the largest initiatives to date in terms of integrating valuable input from a wide range of relevant decision-makers and – importantly – the cancer patient perspective.

Key stakeholders and how the recommendations will benefit the cancer community

As a public-private collaborative project, SISAQOL-IMI brings together 41 stakeholder groups, including researchers from the pharmaceutical industry, academia, cancer institutes, PRO experts, regulators, non-profit associations, and patient representatives and advocacy organizations.

Buy-in of the final consensus recommendations by all stakeholders will be critical to the success of this project and to ensure this happens, we are involving them throughout the process.

To begin with, stakeholders’ needs are being assessed, before their role turns to being advisors who shape the recommendations and methods of standardization. A crucial part of SISAQOL-IMI will be the consensus meetings, which will be held at key milestones over the four years of the project to allow partners to discuss recommendations, resolve areas of disagreement, and agree on next steps. Each milestone will result in a consensus report, which when collated will form the basis of the standards.

The final recommendations will benefit the cancer community by improving their understanding of the role of PRO measures in academic research, drug development, and drug approval by regulators and Health Technology Assessment (HTA) bodies. It will also guide the community in using PROs in a methodologically robust manner, analyzing them in a statistically adequate way, and presenting findings intelligibly. This will ensure a high study quality and better comparability of results across trials.

A project designed with patients in mind

Patients bring a deep understanding of their experience with cancer and its treatments, and this allows for more impactful delivery of patient-relevant outcomes. Therefore, patients’ insight on the research objectives, study design and interpretation of PRO findings must be highly valued.

In the SISAQOL-IMI project, patient representatives and clinicians will be involved throughout the development of the recommendations, including contributing to a layperson version for patients and the wider public. This will ensure that the outputs from SISAQOL-IMI are understandable and meaningful to stakeholders with a non-statistical background.

In the long run, we would like to see these standards provide a more robust and reliable basis for joint decision-making between patients and physicians, which will undoubtedly lead to improved outcomes and treatment satisfaction.

What next?

SISAQOL-IMI is a strong example of how researchers from academia and industry can truly partner with regulators and patient organizations to develop useful recommendations for cancer clinical trials, and in doing so, address an unmet need.

The initial aim is to map and understand stakeholders’ needs in terms of standardizing the use of PRO data. The end goal, four years from now, is to see conclusions based on PRO data from cancer clinical trials being reliable, robust, interpretable, clinically meaningful, replicable and trustworthy. SISAQOL-IMI will raise the standards and optimize the use of these valuable data, ensuring that cancer patients’ voices are accurately represented and efficiently communicated in the benefit and risk assessments of cancer therapies.

Launching the project is just the first step. There is a lot of work ahead of us, but we will collaborate for consensus, with the benefits this will provide to cancer patients at the core of our efforts.

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PRESS RELEASE: Generating recommendations for the design, analysis and interpretation of patient- reported outcome (PRO) data for cancer clinical trials: the launch of SISAQOL-IMI

17th February 2021

An international multidisciplinary consortium, co-led by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI), 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 (Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials – 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 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. The project aims to improve the interpretability of cancer clinical trials and thereby (in the long run) also provide a more solid and reliable basis for shared decision making between patients and physicians to improve outcomes, treatment satisfaction, and care treatment decisions in clinical practice.

Andrew Bottomley, Assistant Director and Head of the Quality of Life Department at the EORTC and SISAQOL-IMI project coordinator said,

“Outcomes from this project will help us understand more about the impact of treatment on the lives of patients. We are looking forward to working with our project partners to generate recommendations that will be useful to so many different stakeholders ”

Kathy Oliver, Chair and Co-Director of the International Brain Tumour Alliance also commented,

“The SISAQOL-IMI initiative is a ground-breaking project which will set much-needed international standards for PRO data analysis in cancer clinical trials. We look forward to WECAN’s involvement with this exciting initiative”

Dr Ingolf Griebsch Head of Corporate Market Access Oncology at Boehringer Ingelheim and SISAQOL-IMI project leader said,

“SISAQOL-IMI is a great example of how researchers from academia and industry can truly partner with regulators and patient organisations to develop useful recommendations for interpreting PRO data in the future”

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

More Information

Please contact: galinsky@mpeurope.org

For more information on IMI projects: https://www.imi.europa.eu

Disclaimer

This communication reflects the author’s view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 945052. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

Stakeholder organisations

AbbVie

Adelphi Values

American Society for Clinical Oncology

Bayer

Boehringer Ingelheim

Clinical Hospital Center Rijeka

Complejo Hospitalario de Navarra

Critical Path Institute

Duke University School of Medicine (to represent ISPOR)

European Medicines Agency

European Organisation for Research and Treatment of Cancer

European Society for Medical Oncology

Evaluation Software Development

Health Canada

Institut Hospital del Mar d’Investigacions Mèdiques

Institute for Quality and Efficiency in Health Care

John Hopkins University (representing PROTEUS and PRO Data Presentation Stakeholder Group)

KU Leuven

Leiden University

Medical University of Innsbruck

Medicines and Healthcare products Regulations Agency

Merck Healthcare KGaA

Modus Outcomes

Myeloma Patients Europe (representing WECAN)

National Cancer Center Hospital (representing the Japanese Clinical Oncology Group)

Norwegian Medicines Agency

Oslo University Hospital

Patient Relevant Evidence

Pfizer

Queen’s Cancer Research Institute

Region Hovedstaden

The Princess Margaret Cancer Centre/University Health Network

Therapeutic Goods Administration

University of Birmingham (to represent SPIRIT-PRO/CONSORT-PRO)

University of Freiburg (representing STRATOS)

University of Ghent (representing STRATOS)

University of Leeds (representing NCRI)

University of Sydney (representing Australian Clinical Trial Group)

University of Texas (MD Anderson Cancer Center)

US Food and Drug Administration

VU Amsterdam

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Lancet website

Read our systematic review on patient-reported outcomes in metastatic breast cancer

There is little consensus on how PRO and HRQoL data should be analyzed in randomized clinical trials. This systematic review evaluates the current situation in the field of metastatic breast cancer, revealing the many statistical issues that need to be addressed to improve the analysis and interpretation of PRO data.

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The SISAQOL initiative during the 5th EORTC Quality of Life Conference in Brussels

Several SISAQOL Consortium members presented during the 5th EORTC Quality of Life Conference in Brussels.
Recordings from the conference presentations, including the presentation on the SISAQOL work, are available on the conference website.

Visit the conference website
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