Factors of feasibility: an interview study of physicians’ experiences of expanded access to investigational drugs in three countries

Stefan F. Vermeulen, Marjolijn Hordijk, Nikkie Aarts, Eline M. Bunnik*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Seriously ill patients who have exhausted all approved treatment regimens and who cannot be enrolled in clinical trials may resort to expanded access programmes in order to gain access to unapproved, investigational drugs. It seems that in some countries, expanded access to investigational drugs is offered in clinical practice on a more routine basis than in other countries. This study is the first to investigate the experiences of physicians with expanded access to investigational drugs in different healthcare systems, with a focus on factors that facilitate or hinder expanded access. Semi-structured interviews (n = 36) were carried out with medical specialists in the Netherlands (n = 14), Turkey (n = 9) and the United States of America (n = 13), and analysed thematically. This study identifies five sets of factors pointed out by physicians that determine the degree to which expanded access to investigational drugs is deemed feasible in clinical practice: the suitability of investigational treatments, the application process, hospital policies, support by pharmaceutical companies, and funding and reimbursement arrangements. Based on the interviews conducted, we conclude that, while legally allowed and technically possible, expanded access is not always feasible for—and not always considered an option by—treating physicians. This is mainly due to lack of familiarity with expanded access, the extensive time and effort required for the application process, willingness or ability of pharmaceutical companies to supply the drugs, and funding issues.

Original languageEnglish
Article number275
JournalHumanities and Social Sciences Communications
Volume8
Issue number1
DOIs
Publication statusPublished - 17 Nov 2021

Bibliographical note

Funding Information:
This article is part of the research project ‘Nice to meet? Meeting unmet medical needs: a social innovation to facilitate early access to investigational drugs’ (grant no. 313-99-311) funded within the Responsible Innovation (MVI) programme of the Dutch Research Council (NWO). myTomorrows is involved in the research project as a private partner. The funding organization and the private partner have not been involved in the design or conduct of the study, the collection, analysis or interpretation of data, or the writing or publication of this manuscript. myTomorrows is an online platform that informs physicians and patients around the world about expanded access and offers expanded access programmes.

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

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