SISAQOL-IMI

Yesterday SISAQOL-IMI and FDA representatives attended an ASA Biopharmaceutical Section workshop. The panel discussed practical considerations with regards to the analysis, design and reporting of PRO data for Cancer Clinical Trials.

SISAQOL-IMI and FDA representatives will attend an ASA Biopharmaceutical Section workshop to discuss methodological issues surrounding the design and analysis of PRO data for cancer clinical trials. Practical considerations on how to align the PRO objective with the design and analysis using the estimand framework will be presented together with the guidelines on submitting PRO data to FDA and interpreting PRO findings. Speakers: Satrajit Roychoudhury, Weimeng Wang, Madeline Pe, Monica Morell, Mallorie Fiero, Flora Mulkey

We are thrilled to announce that #SISAQOL-IMI has been awarded the prestigious SPAIG Award for 2024 by the American Statistical Association - ASA. This award honours exceptional collaborations between academia, industry, and government.   The awards ceremony took place at the Joint Statistical Meetings (JSM) on Tuesday, August 6th, following the ASA President’s Address.   Congratulations to all SISAQOL-IMI Consortium members! Innovative Health Initiative (IHI) EORTC - European Organisation for Research and Treatment of Cancer Boehringer Ingelheim Amsterdam UMC Adelphi Values Medizinische Universität Innsbruck Duke University School of Medicine Critical Path Institute (C-Path) Klinički Bolnički Centar Rijeka - lokalitet Sušak Medicines and Healthcare products Regulatory Agency Health Canada | Santé Canada University of Toronto Queen's University Norwegian Medical Products Agency The PROTEUS Consortium AbbVie Bayer Evaluation Software Development (ESD) Ghent University Pfizer American Society of Clinical Oncology (ASCO) Modus Outcomes Myeloma Patients Europe (MPE) Leiden University Navarrabiomed, biomedical research centre Katholieke Universiteit Leuven (KU Leuven) CPROR UoB University of Leeds Universitätsklinikum Freiburg Akademie für medizinische Berufe Freiburg im Breisgau Hospital del Mar Research Institute Oslo University Hospital Merck University of Sydney ESMO - European Society for Medical Oncology Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) FDA European Medicines Agency @japan clinical oncology group @stratos initiative

Tomorrow SISAQOL-IMI consortium members will be presenting different stakeholder perspectives on PRO's at the "Are Clinical Outcome Assessments Sufficiently Valued?" webinar, run by ISPOR—The Professional Society for Health Economics and Outcomes Research. Sign up to attend here: https://lnkd.in/eZVh8pzT

Today is the 1st day of the SISAQOL-IMI Consensus meeting #4. WP1 kicks it off with an overview of SISAQOL-IMI's vision and work to date. Today we will vote on further recommendation statements for WP 2,3,6,7, and 8. #cancerclinicaltrials #QoL #PROs

Tomorrow #SISAQOL-IMI will meet in Hamburg for the fourth consensus meeting. During the meeting work packages will address scientific issues regarding the analysis of Patient Reported Outcome (PRO) data and subsequently all 41 stakeholders will vote on the updated proposed reccommendations. More information about SISAQOL-IMI: https://lnkd.in/eGS7xqyE #SISAQOL #PROs #cancerclinicaltrials #qualityoflife #QOL #QLG  

Many consortium members are attending the joint EORTC - European Organisation for Research and Treatment of Cancer and European Medicines Agency workshop on how PROs and HRQoL data can inform regulatory decisions for cancer treatments. Many interesting discussions are taking place on the challenges in the field from different stakeholder perspectives, hightlighting the importance of #SISAQOLIMI .

SISAQOL-IMI is a multi-stakeholder project allowing for fruitful discussions with varying perspectives. Find out more about the collaborative approaches from our project coordinators Madeline Pe and Anders Ingelgaard and their experiences working with academia and industry. https://lnkd.in/eYd-7zm2

Over the next 2 days the SISAQOL-IMI consortium will be meeting virtually to discuss potential revisions of SISAQOL-IMI recommendation statements, discuss plans for the 4th consensus meeting in 2024 and brainstorm the sustainability plan of SISAQOL-IMI after project ends. #sisaqolimi #qol #cancerclinicaltrials

Madeline Pe presented at ESMO - European Society for Medical Oncology on SISAQOL-IMI, what the current issues are in designing, analysing and reporting PRO data in cancer clinical trials, and the importance of the upcoming SISAQOL-IMI reccommendations. #sisaqol #prodata #ESMO2023