Evidence map›Paper›PMID 42332644›Full record

ArticleBMC medical ethics2026

Motivations and experiences in controlled human infection trials vs. phase I clinical trials: a survey study.

Victor M Cnossen, Olivia A C Lamers, Rogier P van Leeuwen, Paul Zimmer-Harwood, Meta Roestenberg, Ingrid M C Kamerling, Marie-Astrid Hoogerwerf

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medical ethics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Victor M Cnossen *Centre for Human Drug Research, Zernikedreef 8, Leiden, 2333 CL, The Netherlands. VCnossen@CHDR.nl.ORCID http://orcid.org/0009-0007-5529-2839
Olivia A C Lamers *Leiden University Center for Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands.
Rogier P van LeeuwenCentre for Human Drug Research, Zernikedreef 8, Leiden, 2333 CL, The Netherlands.
Paul Zimmer-Harwood1DaySooner, Claymont, USA.
Meta RoestenbergLeiden University Center for Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands.
Ingrid M C KamerlingCentre for Human Drug Research, Zernikedreef 8, Leiden, 2333 CL, The Netherlands.
Marie-Astrid HoogerwerfLeiden University Center for Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundControlled human infection (CHI) trials deliberately expose healthy participants to a pathogen. Although they share design features with phase I clinical trials, CHI trials may differ in participant burden and administrative burden. Literature on CHI participant motivations and trial experience compared to phase I participants is limited.

methodsWe conducted a survey comparing motivation, decision-making, and ethical views among CHI and phase I participants, using a previously validated questionnaire. Descriptive and comparative analyses assessed motivational drivers and ethical attitudes.

resultsIn total, 70 CHI and 98 phase I participants were included. Distribution of motivation was different for CHI compared to phase I participants, with reimbursement being a less prominent motivator, and more altruistic factors reported. CHI participants experienced more severe symptoms and reported symptoms as an important factor in the decision to participate. Views on key ethical principles such as reimbursement and burden of participation were similar between participant groups.

conclusionOverall, findings suggest CHI participants experienced more symptoms than phase I participants, but that CHI participation was a well-informed decision, with symptom burden taken into account. This informs future CHI trial design and warrants further research on symptoms and participant experience in CHI trials.

Indexed as

Clinical Trials, Phase I as TopicDecision MakingHuman Challenge Trials as TopicMotivationResearch SubjectsAdultAgedAltruismFemaleHumansMaleMiddle AgedSurveys and QuestionnairesYoung AdultClinical trialsControlled human infection modelParticipant experienceParticipant motivationParticipant-reported outcomesPhase I trialsQuestionnaireSurvey

Identifiers

PMID42332644
PMCPMC13540935

What OpenQuestion holds

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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.