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

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...

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Autores principales:	Stefan F. Vermeulen, Marjolijn Hordijk, Nikkie Aarts, Eline M. Bunnik
Formato:	article
Lenguaje:	EN
Publicado:	Springer Nature 2021
Materias:	History of scholarship and learning. The humanities AZ20-999 Social Sciences H
Acceso en línea:	https://doaj.org/article/0f58b7b53e73487187e954871b3b8264
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spelling	oai:doaj.org-article:0f58b7b53e73487187e954871b3b82642021-11-21T12:28:14ZFactors of feasibility: an interview study of physicians’ experiences of expanded access to investigational drugs in three countries10.1057/s41599-021-00950-32662-9992https://doaj.org/article/0f58b7b53e73487187e954871b3b82642021-11-01T00:00:00Zhttps://doi.org/10.1057/s41599-021-00950-3https://doaj.org/toc/2662-9992Abstract 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.Stefan F. VermeulenMarjolijn HordijkNikkie AartsEline M. BunnikSpringer NaturearticleHistory of scholarship and learning. The humanitiesAZ20-999Social SciencesHENHumanities & Social Sciences Communications, Vol 8, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	History of scholarship and learning. The humanities AZ20-999 Social Sciences H
spellingShingle	History of scholarship and learning. The humanities AZ20-999 Social Sciences H Stefan F. Vermeulen Marjolijn Hordijk Nikkie Aarts Eline M. Bunnik Factors of feasibility: an interview study of physicians’ experiences of expanded access to investigational drugs in three countries
description	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.
format	article
author	Stefan F. Vermeulen Marjolijn Hordijk Nikkie Aarts Eline M. Bunnik
author_facet	Stefan F. Vermeulen Marjolijn Hordijk Nikkie Aarts Eline M. Bunnik
author_sort	Stefan F. Vermeulen
title	Factors of feasibility: an interview study of physicians’ experiences of expanded access to investigational drugs in three countries
title_short	Factors of feasibility: an interview study of physicians’ experiences of expanded access to investigational drugs in three countries
title_full	Factors of feasibility: an interview study of physicians’ experiences of expanded access to investigational drugs in three countries
title_fullStr	Factors of feasibility: an interview study of physicians’ experiences of expanded access to investigational drugs in three countries
title_full_unstemmed	Factors of feasibility: an interview study of physicians’ experiences of expanded access to investigational drugs in three countries
title_sort	factors of feasibility: an interview study of physicians’ experiences of expanded access to investigational drugs in three countries
publisher	Springer Nature
publishDate	2021
url	https://doaj.org/article/0f58b7b53e73487187e954871b3b8264
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Factors of feasibility: an interview study of physicians’ experiences of expanded access to investigational drugs in three countries

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