Evidence map›Paper›PMID 42836097›Full record

ArticleTrends open2026

Clinical trial laboratory principles for emerging infectious disease research in resource-limited settings.

Daniel Mukadi-Bamuleka, Kathryn Shaw-Saliba, Emily Yox, Michael Kombozi Basika, Nadeeka Randunu, Nella Bisento, Amie Jarra, Tina Bakutumba, Sara Zufan, Michel Ngimba and 13 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trends open, 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
–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

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

23 authors.

Daniel Mukadi-BamulekaInstitut National de Recherche Biomédicale, INRB, Kinshasa, Democratic Republic of the Congo.
Kathryn Shaw-SalibaDivision of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda and Frederick, MD, USA.
Emily YoxClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Michael Kombozi BasikaInstitut National de Recherche Biomédicale, INRB, Kinshasa, Democratic Republic of the Congo.
Nadeeka RandunuClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Nella BisentoInstitut National de Recherche Biomédicale, INRB, Kinshasa, Democratic Republic of the Congo.
Amie JarraIntegrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Fort Detrick, Frederick, MD, USA.
Tina BakutumbaInstitut National de Recherche Biomédicale, INRB, Kinshasa, Democratic Republic of the Congo.
Sara ZufanIntegrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Fort Detrick, Frederick, MD, USA.
Michel NgimbaInstitut National de Recherche Biomédicale, INRB, Kinshasa, Democratic Republic of the Congo.
Dido MpunguInstitut National de Recherche Biomédicale, INRB, Kinshasa, Democratic Republic of the Congo.
Grace Kilonda PelaInstitut National de Recherche Biomédicale, INRB, Kinshasa, Democratic Republic of the Congo.
Lebon MatendoInstitut National de Recherche Biomédicale, INRB, Kinshasa, Democratic Republic of the Congo.
Nsengi NtamabyaliroInstitut National de Recherche Biomédicale, INRB, Kinshasa, Democratic Republic of the Congo.
H Clifford LaneDivision of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda and Frederick, MD, USA.
Placide Mbala-KingebeniInstitut National de Recherche Biomédicale, INRB, Kinshasa, Democratic Republic of the Congo.
Richard DaveyDivision of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Jens H KuhnIntegrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Fort Detrick, Frederick, MD, USA.
Ian CrozierClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Lori E DoddDivision of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda and Frederick, MD, USA.
Olivier Tshiani MbayaInstitut National de Recherche Biomédicale, INRB, Kinshasa, Democratic Republic of the Congo.
Veronique NussenblattDivision of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda and Frederick, MD, USA.
Irina Maljkovic BerryIntegrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Fort Detrick, Frederick, MD, USA.

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI BRISCOE, LYNN · 2019 to 2025
$3932.6M
NIH HHS 75N91019D00024NIH HHS HHSN272201800013C
6 · The paper itself

Abstract

For emerging and re-emerging viral diseases, the timing and location of outbreaks are typically unpredictable and may require rapid implementation of randomized controlled trials (RCTs) to evaluate safety and efficacy of candidate vaccines or therapeutics. In austere and hard-to-reach settings, establishing effective laboratory operations for RCTs requires considerable effort to address both anticipated and unforeseen challenges. Here, we describe key principles and practical challenges associated with effective research laboratory operationalization in the context of a double-blinded, placebo-controlled RCT for evaluation of an mpox candidate therapeutic in the Democratic Republic of the Congo. The solutions implemented and lessons learned may inform the planning and operationalization of clinical trial laboratories in resource-limited outbreak settings and provide a framework to guide future efforts.

Indexed as

clinical trial laboratoryemerging disease outbreakmpoxresearch responseresource-limited

Identifiers

PMID42836097
PMCPMC13637558

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.