EMA and European Organisation for Research and Treatment of Cancer (EORTC) workshop: How can patient-reported outcomes (PRO) and health-related quality of life (HRQoL) data inform regulatory decisions?

• Date:
  Thursday, 29 February 2024, 13:00 (CET) - 19:00 (CET)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands
  Live Broadcast

Event summary

The European Medicines Agency (EMA) and the European Organisation for Research and Treatment of Cancer (EORTC) are jointly organising a workshop on how patient-reported outcomes (PRO) as well as health-related quality of life (HRQoL) data can inform regulatory decisions (please see the draft agenda attached).

This workshop will bring together international experts from academia, learned societies, patients, regulatory agencies, health technology assessment bodies, and industry.
 The aims of the workshop are to:

• Understand the current global landscape on the use of PROs and HRQOL for evaluation of anti-cancer treatments across different stakeholder groups.
• Understand the use of validated PRO questionnaires to measure core HRQOL outcomes and disease-related symptoms; and PRO Item Libraries in the development of trial-specific/treatment-specific item lists.
• Facilitate interactions among relevant stakeholders aiming at international collaboration. 

Please note that in-person participation will be subject to confirmation by 22nd January 2024 to ensure equal input from all stakeholders and taking into consideration the capacity of the venue.

The recording of this meeting will be made available after the event.

Video recording

Documents

Agenda - How can Patient Reported Outcomes (PROs) and Health Related Quality of Life (HRQoL) data inform regulatory decisions for cancer treatments?

Adopted

Presentation - Patients’ Involvement, what Does that Mean? Variability between diseases and patients (P. Demolis)

Presentation - Evaluating cancer treatments based on overall survival and quality of life (W. van der Graaf)

Presentation - The tale of two trials: Improving the use of PROs and HRQoLin cancer clinical research (J. Reijneveld)

Presentation - EMA current and future activities on Patient Experience Data (PED), including PROs and HRQoL in medicines’ development and evaluation (J. Garcia Burgos, EMA)

Presentation - Learnings from a review of patient reported outcomes used for regulatory approval of oncology medicinal products in the European Union between 2017 and 2020 (C. Torre)

Presentation - Patient-Reported Outcomes in Oncology Trials (V. Bhatnagar)

Presentation - Application and importance of HRQoL/PRO assessment from the HTA perspective (B. Wieseler)

Presentation - Enhancing Benefit Risk Assessment: Integrating Survival Data and Longitudinal Patient reported Outcome Data (D. Postmus)

Presentation - EORTC’s strategy on the development and implementation of PRO and HRQoLmeasures for cancer clinical research (M. Groenvold)

Presentation - Measuring HRQOL core outcomesand disease-specific symptoms (Classified as public by the European Medicines Agency (J. M. Giesinger)

Presentation - Measuring treatment-specific side effects from the patient perspective: Trial-specific item lists from PRO item libraries (A. Gilbert, C. Piccinin)

Presentation - Use of static and flexible PRO measures in global cancer trials: Challenges and opportunities (J. Shaw)