Evidence map›Paper›PMID 34990453›Full record

ArticlePLoS neglected tropical diseases2022

A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever.

Adebola Tolulope Olayinka, Josephine Bourner, George O Akpede, Joseph Okoeguale, Chukwuyem Abejegah, Nnennaya A Ajayi, Christian Akude, Oluwafemi Ayodeji, Daniel G Bausch, Hilde de Clerck and 26 more

Open access · goldAbstract read
In one paragraph

Article in PLoS neglected tropical diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 8% of its field
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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. 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

36 authors at 14 institutions in 8 countries.

Adebola Tolulope OlayinkaNigeria Centre for Disease Control, Abuja, Nigeria.ORCID 0000-0002-6023-8403
Josephine BournerCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.ORCID 0000-0003-4687-8380
George O AkpedeIrrua Specialist Teaching Hospital, Irrua, Edo, Nigeria.ORCID 0000-0003-1035-4067
Joseph OkoegualeIrrua Specialist Teaching Hospital, Irrua, Edo, Nigeria.
Chukwuyem AbejegahFederal Medical Center, Owo, Ondo State, Nigeria.ORCID 0000-0001-9088-9197
Nnennaya A AjayiAlex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.
Christian AkudeBingham University Teaching Hospital, Jos, Nigeria.
Oluwafemi AyodejiFederal Medical Center, Owo, Ondo State, Nigeria.
Daniel G BauschUK Public Health Rapid Support Team, Public Health England, London, United Kingdom.ORCID 0000-0002-7209-6983
Hilde de ClerckMédecins sans Frontières, Brussels, Belgium.ORCID 0000-0003-0145-4242
Chioma Dan-NwaforNigeria Centre for Disease Control, Abuja, Nigeria.ORCID 0000-0002-3294-2276
Jake DunningCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.ORCID 0000-0002-4035-4562
Cyril EramehIrrua Specialist Teaching Hospital, Irrua, Edo, Nigeria.ORCID 0000-0001-7783-2495
Justus Ndulue EzeAlex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.ORCID 0000-0002-4695-071X
Pierre FormentyWorld Health Organisation, Geneva, Switzerland.ORCID 0000-0002-9482-5411
Annelies GillesenCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.ORCID 0000-0002-3170-8226
Sulaiman JallohOla During Children's Hospital, Freetown, Sierra Leone.
Marie JaspardThe Alliance for International Medical Action (ALIMA), Dakar, Senegal.
Tolulope JegedeFederal Medical Center, Owo, Ondo State, Nigeria.ORCID 0000-0002-1983-7957
Jacob MaikereMédecins sans Frontières, Brussels, Belgium.
Denis MalvyThe Alliance for International Medical Action (ALIMA), Dakar, Senegal.
Ephraim Ogbaini-EmovonIrrua Specialist Teaching Hospital, Irrua, Edo, Nigeria.
Olalekan Ezekial OjoFederal Medical Center, Owo, Ondo State, Nigeria.ORCID 0000-0001-9429-4000
Sylvanus OkogbeninIrrua Specialist Teaching Hospital, Irrua, Edo, Nigeria.
Kwame O'NeillMinistry of Health and Sanitation, Freetown, Sierra Leone.
Maria-Lauretta OrjiAlex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.ORCID 0000-0001-7082-8506
Sampson Omagbemi OwhinFederal Medical Center, Owo, Ondo State, Nigeria.ORCID 0000-0003-1258-2995
Michael RamharterBernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.ORCID 0000-0002-9259-1885
Robert J SamuelsKenema Government Hospital, Kenema, Sierra Leone.
Nathan ShehuJos University Teaching Hospital, Jos, Plateau State, Nigeria.ORCID 0000-0001-8802-4928
Laura MersonCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.ORCID 0000-0002-4168-1960
Alex Paddy SalamCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
Nzelle Delphine KayemCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
Peter HorbyCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
Chikwe IhekweazuNigeria Centre for Disease Control, Abuja, Nigeria.
Piero OlliaroCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.ORCID 0000-0003-1426-3680
University of Oxford · GBFederal Medical Centre · NGIrrua Specialist Teaching Hospital · NGFederal Teaching Hospital Abakaliki · NGNigeria Centre for Disease Control · NGInserm · FRMédecins Sans Frontières · BEPublic Health England · GBBingham University · NGJos University Teaching Hospital · NGMinistry of Health and Sanitation · SLUniversität Hamburg · DEUniversity of Sierra Leone · SLWorld Health Organization · CH

Funding

Wellcome TrustWorld Health Organization 001
6 · The paper itself

Abstract

backgroundOnly one recommendation currently exists for the treatment of Lassa fever (LF), which is ribavirin administered in conjunction with supportive care. This recommendation is primarily based on evidence generated from a single clinical trial that was conducted more than 30 years ago-the methodology and results of which have recently come under scrutiny. The requirement for novel therapeutics and reassessment of ribavirin is therefore urgent. However, a significant amount of work now needs to be undertaken to ensure that future trials for LF can be conducted consistently and reliably to facilitate the efficient generation of evidence. METHODOLOGY: We convened a consultation group to establish the position of clinicians and researchers on the core components of future trials. A Core Eligibility Criteria (CEC), Core Case Definition (CCD), Core Outcome Set (COS) and Core Data Variables (CDV) were developed through the process of a multi-stakeholder consultation that took place using a modified-Delphi methodology.

resultsA consensus position was achieved for each aspect of the framework, which accounts for the inclusion of pregnant women and children in future LF clinical trials. The framework consists of 8 core criteria, as well as additional considerations for trial protocols.

conclusionsThis project represents the first step towards delineating the clinical development pathway for new Lassa fever therapeutics, following a period of 40 years without advancement. Future planned projects will bolster the work initiated here to continue the advancement of LF clinical research through a regionally-centred, collaborative methodology, with the aim of delineating a clear pathway through which LF clinical trials can progress efficiently and ensure sustainable investments are made in research capacity at a regional level.

Indexed as

Antiviral AgentsClinical Trials, Phase III as TopicDrug DevelopmentDrug DiscoveryHumansLassa FeverLassa virusResearch DesignSurveys and QuestionnairesAntiviral Agents

Identifiers

PMID34990453
PMCPMC8769305
OpenAlexW4205558600

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.