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

dc.rights.licenseopenen_US
dc.contributor.authorOLAYINKA, Adebola Tolulope
dc.contributor.authorBOURNER, Josephine
dc.contributor.authorAKPEDE, George O
dc.contributor.authorOKOEGUALE, Joseph
dc.contributor.authorABEJEGAH, Chukwuyem
dc.contributor.authorAJAYI, Nnennaya A.
dc.contributor.authorAKUDE, Christian
dc.contributor.authorAYODEJI, Oluwafemi
dc.contributor.authorBAUSCH, Daniel G.
dc.contributor.authorDE CLERCK, Hilde
dc.contributor.authorDAN-NWAFOR, Chioma
dc.contributor.authorDUNNING, Jake
dc.contributor.authorERAMEH, Cyril
dc.contributor.authorEZE, Justus Ndulue
dc.contributor.authorFORMENTY, Pierre
dc.contributor.authorGILLESEN, Annelies
dc.contributor.authorJALLOH, Sulaiman
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorJASPARD, Marie
dc.contributor.authorJEGEDE, Tolulope
dc.contributor.authorMAIKERE, Jacob
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorMALVY, Denis
dc.contributor.authorOGBAINI-EMOVON, Ephraim
dc.contributor.authorOJO, Olalekan Ezekial
dc.contributor.authorOKOGBENIN, Sylvanus
dc.contributor.authorO'NEILL, Kwame
dc.contributor.authorORJI, Maria-Lauretta
dc.contributor.authorOWHIN, Sampson Omagbemi
dc.contributor.authorRAMHARTER, Michael
dc.contributor.authorSAMUELS, Robert J.
dc.contributor.authorSHEHU, Nathan
dc.contributor.authorMERSON, Laura
dc.contributor.authorSALAM, Alex Paddy
dc.contributor.authorKAYEM, Nzelle Delphine
dc.contributor.authorHORBY, Peter
dc.contributor.authorIHEKWEAZU, Chikwe
dc.contributor.authorOLLIARO, Piero
dc.date.accessioned2022-03-07T11:26:32Z
dc.date.available2022-03-07T11:26:32Z
dc.date.issued2022-01-06
dc.identifier.issn1935-2735 (Electronic) 1935-2727 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/128851
dc.description.abstractEnBACKGROUND: Only 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. RESULTS: A 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. CONCLUSIONS: This 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.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.title.enA standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever
dc.typeArticle de revueen_US
dc.identifier.doi10.1371/journal.pntd.0010089en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed34990453en_US
bordeaux.journalPLoS Neglected Tropical Diseasesen_US
bordeaux.volume16en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue1en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamGHIGS_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDBill and Melinda Gates Foundationen_US
hal.identifierhal-03599628
hal.version1
hal.date.transferred2022-03-07T11:26:38Z
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=PLoS%20Neglected%20Tropical%20Diseases&rft.date=2022-01-06&rft.volume=16&rft.issue=1&rft.eissn=1935-2735%20(Electronic)%201935-2727%20(Linking)&rft.issn=1935-2735%20(Electronic)%201935-2727%20(Linking)&rft.au=OLAYINKA,%20Adebola%20Tolulope&BOURNER,%20Josephine&AKPEDE,%20George%20O&OKOEGUALE,%20Joseph&ABEJEGAH,%20Chukwuyem&rft.genre=article


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