The Role of Physicians in Expanded Access to Investigational Drugs: A Mixed-Methods Study of Physicians’ Views and Experiences in The Netherlands

Eline M. Bunnik*, Nikkie Aarts

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

10 Citations (Scopus)

Abstract

Treating physicians have key roles to play in expanded access to investigational drugs, by identifying investigational treatment options, assessing the balance of risks and potential benefits, informing their patients, and applying to the regulatory authorities. This study is the first to explore physicians’ experiences and moral views, with the aim of understanding the conditions under which doctors decide to pursue expanded access for their patients and the obstacles and facilitators they encounter in the Netherlands. In this mixed-methods study, semi-structured interviews (n = 14) and a questionnaire (n = 90) were conducted with medical specialists across the country and analysed thematically. Typically, our respondents pursue expanded access in “back against the wall” situations and broadly support its classic requirements. They indicate practical hurdles related to reimbursement, the amount of time and effort required for the application, and unfamiliarity with the regulatory process. Some physicians are morally opposed to expanded access, with an appeal to safety risks, lack of evidence, and “false hope.” Some of these moral concerns and practical obstacles may be essential targets for change, if expanded access to unapproved drugs is to become available for wider groups of patients for whom standard treatment options are not—or no longer—available, on a more consistent and equal basis.

Original languageEnglish
Pages (from-to)319-334
Number of pages16
JournalJournal of Bioethical Inquiry
Volume18
Issue number2
DOIs
Publication statusPublished - 15 Feb 2021

Bibliographical note

Publisher Copyright:
© 2021, The Author(s).

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