She has trained in research methodology and statistics for psychological and behavioural outcomes. Madeline has over 8 years of experience developing questionnaires, setting up studies and analysing patient/participant-reported data in different research fields, including education and mental health. Her various research experiences arm her with a broad knowledge of research methodologies and approaches that is useful in advancing the methodological practices in quality of life research. She is one of the scientific leads for the SISAQOL Consortium and is lead author in several SISAQOL publications. Additionally, she is involved in coordinating, and providing scientific and methodological support for various quality of life research activities in EORTC.

Corneel Coens is currently working as a lead statistician at the EORTC Headquarters (Brussels, Belgium). As part of his tasks for the EORTC Quality of Life Department, he is involved in various aspects of Quality of Life in oncological clinical trials ranging from instrument validation to design, analysis and reporting of patient-reported outcomes (PROs). He is one of the lead investigators in the international SISAQOL initiative (aimed at standardizing PROs analysis methods) and the designated study statistician for the EORTC Gynaecological Cancer Group since 2001. He is a regular contributor for various EORTC educational courses and has been course director for the Joint FECS/AACR/ASCO Workshop “Methods in Clinical Cancer Research”.

Michael Schlichting is Director Biostatistics at Merck KGaA. Global. He is biostatistical lead for several oncology compounds since 1995, a PRO subject matter expert, and lead HTA biostatistician.

Prof. Saskia le Cessie is a medical statistician working at the departments of Clinical Epidemiology and Biomedical Data Sciences of Leiden University Medical Center. Her research in medical statistics and epidemiological methods is generally inspired by collaboration with medical researchers. The focus of her current research is on epidemiological and statistical methods for observational studies. This involves (1) collaboration in research projects of clinical epidemiologists and other clinical researchers in order to provide cutting edged statistical analyses in observational clinical studies and (2) to perform research on statistical methodology for epidemiological studies. This has resulted in many publications (>350) as co-author on (bio) medical papers and in papers in methodological journals on causal inference, prediction models, mediation analysis, instrumental variables and meta analysis. She is a member of the Dutch Health Council, an associate editor of Clinical Trials and a member of the Steering Group of the STRATOS initiative, which aims to provide guidance in the design and analysis of observational studies.

Dr. Satrajit Roychoudhury is a Senior Director and a member of Statistical Research and Innovation group in Pfizer Inc. Prior to joining, he was a member of Statistical Methodology and consulting group in Novartis. He started his career as a research statistician in Schering Plough Research Institute (now Merck Co.). He has 14+ years of extensive experience in working with different phases of clinical trial. He has co-authored several publications/book chapters in this area and provided statistical training in major conferences. His area of research includes survival analysis, use of model-based approaches and Bayesian methods in clinical trials. Satrajit was a recipient of a Young Statistical Scientist Award from the International Indian Statistical Association in 2019. He served as the industry co-chair for ASA Biopharmaceutical Section Regulatory-Industry Workshop in 2018.

Bernhard Holzner, PhD, M.Eng., is a clinical psychologist, psychotherapist and clinical researcher. He is the academic leader of SISAQOL-IMI Work Package 4, which focuses on developing recommendations for the graphical representation of patient-reported outcome (PRO) data from cancer clinical trials. Being the founder and leader of the Patient-Reported Outcome (PRO) working group at the Medical University of Innsbruck, Bernhard has been involved in a wide range of PRO research activities over the last 25 years and has built up extensive expertise in the development of PRO measures, their electronic assessment as well as in the use and reporting of PRO data.

Jane Chang, MPH (Senior Director, Value & Evidence Lead for Genitourinary Cancers, Pfizer Oncology). She has over 15 years of experience HEOR within the pharmaceutical industry supporting products in a broad range of therapeutic areas including Oncology, Neuroscience, Dermatology, and Rheumatology in both global and US roles. Jane graduated from University of Michigan, Ann Arbor, with both her BS in Microbiology and MPH in Health Management and Policy. She then completed a 2-year outcomes research fellowship with Duke University and Novartis before being employed at Novartis and later at Bayer. In her 8 and half years at Bayer, Jane implemented market access strategy and HEOR plans for multiple oncology compounds in development and also during product launch. She has received multiple recognition awards at Bayer for her leadership and team work. At Pfizer, Jane has been supporting an Alliance immuno-oncology compound for the past 5 years leading the HEOR strategy and plans for several indications including implementing PROs into clinical trials.

Johannes M. Giesinger, PhD, is a clinical psychologist with a degree in biostatistics, who is leading the SISAQOL-IMI work package 6 on developing recommendations for clinically meaningful change objectives in cancer clinical trials. He has been engaged in research in patient-reported outcomes for 15 years conducting methodological and clinical studies, primarily in the oncological field. A number of his previous projects have focused on facilitating the interpretation of patient-reported outcomes.

Joseph C. Cappelleri earned his MS in statistics from the City University of New York (Baruch College), PhD in psychometrics from Cornell University, and MPH in epidemiology from Harvard University. He is an executive director of biostatistics and the head of HEOR Statistics in the Statistical Research and Data Science Center at Pfizer Inc, where he is the recipient of the Craig A. Saxton Clinical Development Excellence Award (Pfizer’s highest accolade). As an adjunct professor, he has served on the faculties at Brown University (biostatistics), Tufts University School of Medicine (medicine), and the University of Connecticut (statistics). Among the most published authors in the history of Pfizer and the pharmaceutical industry, Joe has co-authored hundreds and hundreds of publications and external presentations on clinical and methodological topics, including regression-discontinuity designs, meta-analysis, and health measurement scales. He is the lead author of the book Patient-Reported Outcomes: Measurement, Implementation and Interpretation and has co-authored or co-edited five other books. Joe is an elected Fellow of the American Statistical Association (ASA), elected recipient of the Long-Term Excellence Award from the Health Policy Statistics Section of the ASA, and elected recipient of the ISPOR Avedis Donabedian Outcomes Research Lifetime Achievement Award.

Kristin Bjordal has, since 2014, been the head of the regional Research Support Services, Oslo University Hospital, Norway, and a professor and the University of Oslo. Before that, she was working as senior consultant and head of unit in medical oncology and radiotherapy at the Norwegian Radium Hospital.

She started her research in 1990 and her PhD “Quality of life in patients treated for head and neck cancer, methodological and clinical issues”, University of Oslo 1996, was strongly influenced by the EORTC. Since 1990, she has been actively involved in various projects in the EORTC Quality of Life Group, such as the development of module development guidelines and the EORTC QLQ-HN35 and the start of the Item bank – later Item library. The last couple of years, she has been the co-chair of the PMDC (project and module development committee) and member of the Executive Committee of the EORTC Quality of Life Group.

She really enjoys discussions and collaborations with students and colleagues and is now happy to be able to use these experiences in this large SISAQOL-IMI-project. As the co-chair of WP7, the main challenge will be to facilitate a process that will end up with a widely recognized consensus-based international recommendation for analysis and interpretation of PRO results.

Silene ten Seldam, BSc, MSc, is a research assistant working in the evidence generation unit at Myeloma Patients Europe. Silene works to ensure that patient and family views are represented in research and decision making. Silene co-leads WP8 within SISAQOL-IMI.