Health Care Professional survey on understanding of key risk minimisation measures related to interstitial lung disease (ILD) / pneumonitis with Trastuzumab Deruxtecan treatment

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46368
• EU PAS number:
  EUPAS46367
• Study ID:
  46368
• Official title and acronym:
  Health Care Professional survey on understanding of key risk minimisation measures related to interstitial lung disease (ILD) / pneumonitis with Trastuzumab Deruxtecan treatment
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Denmark

  France

  Germany

  Spain

  Sweden

  United Kingdom
• Study description:
  Interstitial lung disease (ILD) and/or pneumonitis have been identified as important risks for patients treated with Trastuzumab Deruxtecan, and fatal outcomes have been observed. To prevent / minimize the occurrence of severe ILD/pneumonitis, the Marketing Authorization Holder proposed additional risk minimisation measures (aRMM) for ILD/ pneumonitis and developed educational material. A prescriber survey will be performed in the EU Member States where Trastuzumab Deruxtecan is marketed to evaluate effectiveness of the taken key risk minimisation measures for ILD/ pneumonitis. The aim of this study is to evaluate the effectiveness of Trastuzumab Deruxtecan’s risk minimisation measures for the important identified risk of ILD/pneumonitis by assessing their correct implementation among physicians expected to prescribe Trastuzumab Deruxtecan. Physicians’ knowledge and understanding of the educational material will be evaluated.
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 12/01/2021

Actual: 17/06/2021

Study start date

Planned: 01/03/2022

Actual: 28/03/2022

Date of final study report

Planned: 30/06/2024

Actual: 26/06/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Daiichi Sankyo Europe GmbH

Study protocol

Initial protocol

DSE_T-DXd_HCP Survey_Protocol_v1.0_20Dec2021_blackened

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)