Programme

08:00 – 09:00 Welcome coffee and registration
SESSION 1. Introduction to patient-reported outcomes (PROs) and health-related quality of life (HRQOL) in cancer clinical research
Chairs: Madeline Pe and Dagmara Kuliś
9:00 – 9:15 Welcome and meeting objectives
9:15 – 9:30 Importance of PROs from the patient community perspective – myths and reality of PRO use (Jan Geissler)
9:30 – 9:45 Using PROs in clinical trials and practice (Alexandra Gilbert)
9:45 – 10:00 Evaluating HRQOL in cancer clinical trials: The EORTC measurement strategy (Mogens Groenvold)
SESSION 2. EORTC and ESMO Special Session (ESMO-MCBS)
Chairs: Katarzyna Pogoda and Sjoukje Oosting
10:00 – 10:10 Introduction of session by Chairs
10:10 – 10:30 Why HRQOL is a critical component in the assessment of clinical benefit: The ESMO-MCBS (Sjoukje Oosting)
10:30 – 10:45 Case study: HRQOL endpoint in a breast cancer trial (Katarzyna Pogoda)
10:45 – 11:00 HRQOL benefit in de-escalation trials: Experience from cancer clinical trials in India (Priya Ranganathan)
11:00 – 11:15 The importance of QoL for measuring patient benefit (Ananda Plate)
11:15 – 11:45 Coffee break
SESSION 3. Current developments in EORTC measurement tools and their use in cancer clinical research
Chairs: Sally Wheelwright and Johannes Giesinger
11:45 – 11:55 Introduction of session by Chairs
11:55 – 12:10 Measuring HRQOL core outcomes and disease-specific symptoms: The EORTC QLQ-C30 and its modules (Samantha Sodergren and Francesca Martinelli)
12:10 – 12:25 Developing study-specific item lists with the EORTC Item Library (Claire Piccinin)
12:25 – 12:40 Personalised assessment of HRQOL: EORTC computer adaptive testing tools (Hugo Vachon)
12:40 – 12:55 Health utility assessment with the QLQ-C30: The QLU-C10D (Eva Gamper)
12:55 – 13:10 Addressing missing patient-specific HRQOL issues in questionnaires: The WISP (Write-In three Symptoms/Problems) Instrument (Claire Piccinin)
13:10 – 13:25 Development and translation of linguistically and culturally validated questionnaires (Dagmara Kuliś)
13:25 – 14:45 Lunch break
SESSION 4. Considerations in the assessment of PROs for special cancer patient populations – ”unmet needs”
Chairs: Ananda Plate and Mogens Groenvold
14:45 – 14:55 Introduction of session by Chairs
14:55 – 15:10 Benefits and challenges of PRO assessment in children with cancer (David Riedl)
15:10 – 15:25 Quality of life of adolescents and young adults with cancer (Anne-Sophie Darlington)
15:25 – 15:40 Rare cancers (Olga Husson)
15:40 – 15:55 Cognitively impaired patients (Jaap Reijneveld)
15:55 – 16:10 Older adults (Paolo Bossi)
16:10 – 16:25 Palliative care (Mogens Groenvold)
16:25 – 16:55 Coffee break
SESSION 5. What is a clinically relevant PRO score? Development and methodological considerations
Chairs: Jammbe Musoro and Antoine Regnault
16:55 – 17:05 Introduction of session by Chairs
17:05 – 17:20 Going beyond statistical significance: Is the difference clinically relevant? (Jammbe Musoro)
17:20 – 17:35 Interpreting individual patients’ scores: Determining whether a patient improved or worsened in their HRQOL (Johannes Giesinger)
17:35 – 17:50 The need for reference values and general population norm data for PRO measures (Monika Sztankay)
17:50 – 18:00 Summary and end of the day
18:00 – 19:00 Evening cocktail
08:00 – 09:00 Welcome coffee
SESSION 6. Use of PROs in regulatory and HTA decision-making
Chairs: Jan Geissler and Sigrid Klaar
9:00 – 9:10 Introduction of session by Chairs
9:10 – 9:25 Overview of the role of PROs/HRQOL in the regulatory and HTA framework (Anja Schiel)
9:25 – 9:40 EU regulatory views on the generation and use of patient experience data (Juan García Burgos)
9:40 – 9:55 Role of PROs/HRQOL in HTA evaluations (Kirsten Janke)
9:55 – 10:10 Use of HRQOL in economic evaluations (Jan Liliemark)
10:10 – 10:25 Industry views on the use of PROs in regulatory and HTA decision-making (Sigrid Klaar)
10:25 – 11:00 Coffee break
SESSION 7. Statistical considerations in the use of PROs in cancer clinical trials
Chairs: Madeline Pe and Naomi Kiyota
11:00 – 11:10 Introduction of session by Chairs
11:10 – 11:25 SISAQOL-IMI and the estimand framework (Corneel Coens)
11:25 – 11:40 Randomised controlled trials – example trial (Antoine Regnault)
11:40 – 11:55 Single arm studies – example trial (Jammbe Musoro)
11:55 – 12:10 Phase 1 and dose finding – example trial (Christina Yap)
12:10 – 13:15 Lunch break
SESSION 8. Use of PROs for real world evidence generation and patient management
Chairs: Anja Schiel and Jaap Reijneveld
13:15 – 13:25 Introduction of session by Chairs
13:25 – 13:40 The Cancer Care Ontario early adoption of PROs in clinical practice (Michael Brundage)
13:40 – 13:55 Symptom monitoring in daily clinical practice: Evidence gathered in the last 20 years (Galina Velikova)
13:55 – 14:10 Implementation of PROs in daily clinical practice: Case study (August Zabernigg)
14:10 – 14:25 Incorporation of PROs in registries (Lonneke van de Poll-Franse)
14:25 – 14:40 Implementing PROs in pragmatic precision medicine trials – lessons learned from the PRIME-ROSE community advisory board (Bettina Ryll)
14:40 – 14:55 Collecting PROs as real world data (Erik Briers)
14:55 – 15:15 Coffee break
SESSION 9. Electronic and digital outcome assessments
Chairs: Bettina Ryll and Lonneke van de Poll-Franse
15:15 – 15:25 Introduction of session by Chairs
15:25 – 15:40 Challenges in implementing PROs and digital health solutions in clinical trials led by industry (Paul O’Donohoe)
15:40 – 15:55 Challenges in implementing PRO and digital health solutions in clinical practice (Bernhard Holzner)
15:55 – 16:10 Consensus-developed eCOA resources and recommendations from the Critical Path Institute (Scottie Kern)
16:10 – 16:25 Cutting edge research and academic view on PROs and digital health (Katarzyna Wac)
16:25 – 16:45 Closing remarks and end of the conference