Trade-offs between benefits and harms of drugs: a stated preference study with adult patients with cancer in Europe (Patient preferences)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44575
• EU PAS number:
  EUPAS41433
• Study ID:
  44575
• Official title and acronym:
  Trade-offs between benefits and harms of drugs: a stated preference study with adult patients with cancer in Europe (Patient preferences)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Poland

  Spain
• Study description:
  This is a cross-sectional study where data is collected using a patient preference (PP) survey aiming to assess the patient and disease characteristics that influence cancer treatment preferences towards key endpoints in European patients with cancer. This study will include two phases: A Qualitative Evidence Generation phase with approximately 30 patients with cancer and a Quantitative Evidence Generation phase with approximately 900 patients with cancer. A pilot/feasibility phase with approximately 20 patients with cancer will be included as part of the Quantitative Evidence Generation phase.
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA NL, Real-World-Evidence

Netherlands

Study timelines

Date when funding contract was signed

Planned: 01/12/2020

Actual: 01/11/2020

Study start date

Planned: 04/10/2021

Actual: 01/09/2022

Date of final study report

Planned: 04/03/2022

Actual: 28/04/2023

Sources of funding

EMA

Study protocol

Initial protocol

EMA patient preferences on benefits and harms of cancer drugs_Protocol_v3.0_Clean

Updated protocol

EMA patient preferences on benefits and harms of cancer drugs_Protocol 6 December 2021

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable