Evidence map›Paper›PMID 27550379›Full record

ArticleTrials2016

Stakeholders' views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs.

Shona Kalkman, Ghislaine J M W van Thiel, Diederick E Grobbee, Anna-Katharina Meinecke, Mira G P Zuidgeest, Johannes J M van Delden, Work Package 3 of the IMI GetReal Consortium

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Article in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
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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

7 authors.

Shona KalkmanDepartment of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, 3508, GA, Utrecht, The Netherlands. s.kalkman@umcutrecht.nl.
Ghislaine J M W van ThielDepartment of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, 3508, GA, Utrecht, The Netherlands.
Diederick E GrobbeeDepartment of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Anna-Katharina MeineckeGMACS GHEOR, Bayer Pharma AG, Wuppertal, Germany.
Mira G P ZuidgeestDepartment of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Johannes J M van DeldenDepartment of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, 3508, GA, Utrecht, The Netherlands.
Work Package 3 of the IMI GetReal Consortium

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe explored the views of key stakeholders to identify the ethical challenges of pragmatic trials investigating pharmaceutical drugs. A secondary aim was to capture stakeholders' attitudes towards the implementation of pragmatic trials in the drug development process.

methodsWe conducted semistructured, in-depth interviews among individuals from different key stakeholder groups (academia and independent research institutions, the pharmaceutical industry, regulators, Health Technology Assessment (HTA) agencies and patients' organizations) through telephone or face-to-face sessions. Interviews were structured around the question "what challenges were experienced or perceived during the design, conduct and/or review of pragmatic trials." Respondents were additionally asked about their views on implementation of pragmatic trials in the drug development process. Thematic analysis was used to identify the ethically relevant features across data sets.

resultsWe interviewed 34 stakeholders in 25 individual sessions and four group sessions. The four perceived challenges of ethical relevance were: (1) less controlled conditions creating safety concerns, (2) comparison with usual care potentially compromising clinical equipoise, (3) tailored or waivers of informed consent affecting patient autonomy, and (4) minimal interference with "real-world" practice reducing the knowledge value of trial results.

conclusionsWe identified stakeholder concerns regarding risk assessment, use of suboptimal usual care as a comparator, tailoring of informed consent procedures and ensuring the social value of pragmatic trials. These concerns increased when respondents were asked about pragmatic trials conducted before market authorization.

Indexed as

Attitude of Health PersonnelHealth Knowledge, Attitudes, PracticeResearch DesignStakeholder ParticipationComparative Effectiveness ResearchConsent FormsDrugs, InvestigationalFemaleHumansInformed ConsentInterviews as TopicMalePatient SafetyPhysician's RolePragmatic Clinical Trials as TopicQualitative ResearchDrugs, InvestigationalComparative effectivenessDrug researchPragmatic clinical trialQualitative studyResearch ethics

Identifiers

PMID27550379
PMCPMC4994208

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Registered trials

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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.