Evidence map›Paper›PMID 33590374›Full record

ArticleJournal of bioethical inquiry2021

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

Abstract read
In one paragraph

Article in Journal of bioethical inquiry, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. The economic impact of compassionate use of medicines.BMC health services research · 2021
    Article
  9. Article
  10. Goodbye Hippocrates?Journal of bioethical inquiry · 2021
    Article
  11. Global & regional health technology assessment
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Eline M BunnikDepartment of Medical Ethics, Philosophy and History of Medicine, Erasmus MC, University Medical Centre Rotterdam, Wytemaweg 80, 3015, CN, Rotterdam, The Netherlands. e.bunnik@erasmusmc.nl.ORCID http://orcid.org/0000-0003-1481-6222
Nikkie AartsDepartment of Medical Ethics, Philosophy and History of Medicine, Erasmus MC, University Medical Centre Rotterdam, Wytemaweg 80, 3015, CN, Rotterdam, The Netherlands.

Funding

Nederlandse Organisatie voor Wetenschappelijk Onderzoek 313-99-311
6 · The paper itself

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.

Indexed as

Drugs, InvestigationalPhysiciansHumansNetherlandsResearchTherapies, InvestigationalDrugs, InvestigationalClinical decision-makingCompassionate useEthical issuesExpanded accessMixed methodsMoral responsibilitiesPhysicians’ attitudes

Identifiers

PMID33590374
PMCPMC8324586

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.