Evidence map›Paper›PMID 41299424›Full record

ArticleBMC medical ethics2025

Research ethics and integrity challenges in accelerated clinical trials, an interview study.

Clàudia Pallisé Perelló, Giulia Inguaggiato, Loïs van Eck, Hanna K de Jong, Sabine M Hermans, Martin P Grobusch, Mariëtte van den Hoven, Natalie Evans

Abstract read
In one paragraph

Article in BMC medical ethics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

8 authors.

Clàudia Pallisé PerellóDepartment of Ethics, Law and Humanities, Amsterdam Public Health Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, 1081HV, The Netherlands. c.palliseperello@amsterdamumc.nl.ORCID 0000-0003-1812-6405
Giulia InguaggiatoDepartment of Ethics, Law and Humanities, Amsterdam Public Health Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, 1081HV, The Netherlands.ORCID 0000-0003-2340-908X
Loïs van EckDepartment of Infectious Diseases, Centre for Tropical Medicine and Travel Medicine, Amsterdam Public Health - Global Health, and Amsterdam Institute for Immunology and Infectious Diseases, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands.
Hanna K de JongDepartment of Infectious Diseases, Centre for Tropical Medicine and Travel Medicine, Amsterdam Public Health - Global Health, and Amsterdam Institute for Immunology and Infectious Diseases, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands.
Sabine M HermansDepartment of Infectious Diseases, Centre for Tropical Medicine and Travel Medicine, Amsterdam Public Health - Global Health, and Amsterdam Institute for Immunology and Infectious Diseases, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0001-5146-2932
Martin P GrobuschDepartment of Infectious Diseases, Centre for Tropical Medicine and Travel Medicine, Amsterdam Public Health - Global Health, and Amsterdam Institute for Immunology and Infectious Diseases, Amsterdam UMC, location University of Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0002-0046-1099
Mariëtte van den HovenDepartment of Ethics, Law and Humanities, Amsterdam Public Health Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, 1081HV, The Netherlands.ORCID 0000-0003-1416-0972
Natalie EvansDepartment of Ethics, Law and Humanities, Amsterdam Public Health Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, 1081HV, The Netherlands.ORCID 0000-0001-7124-9282

Funding

European Union 101058094
6 · The paper itself

Abstract

backgroundAccelerated clinical trials for drugs and vaccines during global health crises allow for rapid access but pose research ethics and integrity challenges. Understanding these challenges is crucial for preserving research participants' safety and supporting research fairness and trustworthiness. This study aims to explore the research ethics and research integrity challenges associated with the acceleration of clinical trials.

methodsThis qualitative interview study used semi-structured online interviews with key stakeholders in the regulation, design, implementation, and publication of clinical trials as professionals (i.e. trial experts from academia, pharmaceutical companies, non-governmental organizations and national and international regulatory authorities and publishers) recruited using purposive sampling. Interviews were conducted online from April to July of 2023. Transcripts were thematically analysed using deductive and inductive coding through MAXQDA software.

resultsThe main challenges identified were: amplified familiar challenges related to participant recruitment and informed consent; lack of guidance for, and pressure on, ethics and scientific review processes; missing strategies and ambiguous responsibilities in public communication; and poor collaboration, coordination and competition for research resources and supportive structures among research groups Recommendations included: greater engagement with patients throughout the accelerated clinical trial process from design to implementation; providing Research Ethics Committees with specific training on accelerated trials; promoting transparent public communication; fostering international collaboration; and shifting from an industry-centred to a people-centred acceleration.

conclusionThese findings highlight the need for systemic changes in the conduct of accelerated clinical trials, including the openness of clinical research and international coordination to address ethical and integrity issues, ensuring scientific rigor and public trust and promoting justice.

Indexed as

Biomedical ResearchClinical Trials as TopicEthics, ResearchEthics Committees, ResearchFemaleHumansInformed ConsentInterviews as TopicMalePatient SelectionQualitative ResearchResearch DesignResearch PersonnelClinical trialsPandemicResearch ethicsResearch integrityResponsible conduct of research

Identifiers

PMID41299424
PMCPMC12659254

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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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 Socratic graph.