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

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A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever. / Olayinka, Adebola Tolulope; Bourner, Josephine; Akpede, George O; Okoeguale, Joseph; Abejegah, Chukwuyem; Ajayi, Nnennaya A; Akude, Christian; Ayodeji, Oluwafemi; Bausch, Daniel G; de Clerck, Hilde; Dan-Nwafor, Chioma; Dunning, Jake; Erameh, Cyril; Eze, Justus Ndulue; Formenty, Pierre; Gillesen, Annelies; Jalloh, Sulaiman; Jaspard, Marie; Jegede, Tolulope; Maikere, Jacob; Malvy, Denis; Ogbaini-Emovon, Ephraim; Ojo, Olalekan Ezekial; Okogbenin, Sylvanus; O'Neill, Kwame; Orji, Maria-Lauretta; Owhin, Sampson Omagbemi; Ramharter, Michael; Samuels, Robert J; Shehu, Nathan; Merson, Laura; Salam, Alex Paddy; Kayem, Nzelle Delphine; Horby, Peter; Ihekweazu, Chikwe; Olliaro, Piero.

In: PLOS NEGLECT TROP D, Vol. 16, No. 1, e0010089, 01.2022.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Olayinka, AT, Bourner, J, Akpede, GO, Okoeguale, J, Abejegah, C, Ajayi, NA, Akude, C, Ayodeji, O, Bausch, DG, de Clerck, H, Dan-Nwafor, C, Dunning, J, Erameh, C, Eze, JN, Formenty, P, Gillesen, A, Jalloh, S, Jaspard, M, Jegede, T, Maikere, J, Malvy, D, Ogbaini-Emovon, E, Ojo, OE, Okogbenin, S, O'Neill, K, Orji, M-L, Owhin, SO, Ramharter, M, Samuels, RJ, Shehu, N, Merson, L, Salam, AP, Kayem, ND, Horby, P, Ihekweazu, C & Olliaro, P 2022, 'A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever', PLOS NEGLECT TROP D, vol. 16, no. 1, e0010089. https://doi.org/10.1371/journal.pntd.0010089

APA

Olayinka, A. T., Bourner, J., Akpede, G. O., Okoeguale, J., Abejegah, C., Ajayi, N. A., Akude, C., Ayodeji, O., Bausch, D. G., de Clerck, H., Dan-Nwafor, C., Dunning, J., Erameh, C., Eze, J. N., Formenty, P., Gillesen, A., Jalloh, S., Jaspard, M., Jegede, T., ... Olliaro, P. (2022). A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever. PLOS NEGLECT TROP D, 16(1), [e0010089]. https://doi.org/10.1371/journal.pntd.0010089

Vancouver

Olayinka AT, Bourner J, Akpede GO, Okoeguale J, Abejegah C, Ajayi NA et al. A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever. PLOS NEGLECT TROP D. 2022 Jan;16(1). e0010089. https://doi.org/10.1371/journal.pntd.0010089

Bibtex

@article{1b90a6122c204d5890ab8694eae22375,
title = "A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever",
abstract = "BACKGROUND: 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.",
keywords = "Antiviral Agents/pharmacology, Clinical Trials, Phase III as Topic/methods, Drug Development/methods, Drug Discovery/methods, Humans, Lassa Fever/drug therapy, Lassa virus/drug effects, Research Design, Surveys and Questionnaires",
author = "Olayinka, {Adebola Tolulope} and Josephine Bourner and Akpede, {George O} and Joseph Okoeguale and Chukwuyem Abejegah and Ajayi, {Nnennaya A} and Christian Akude and Oluwafemi Ayodeji and Bausch, {Daniel G} and {de Clerck}, Hilde and Chioma Dan-Nwafor and Jake Dunning and Cyril Erameh and Eze, {Justus Ndulue} and Pierre Formenty and Annelies Gillesen and Sulaiman Jalloh and Marie Jaspard and Tolulope Jegede and Jacob Maikere and Denis Malvy and Ephraim Ogbaini-Emovon and Ojo, {Olalekan Ezekial} and Sylvanus Okogbenin and Kwame O'Neill and Maria-Lauretta Orji and Owhin, {Sampson Omagbemi} and Michael Ramharter and Samuels, {Robert J} and Nathan Shehu and Laura Merson and Salam, {Alex Paddy} and Kayem, {Nzelle Delphine} and Peter Horby and Chikwe Ihekweazu and Piero Olliaro",
year = "2022",
month = jan,
doi = "10.1371/journal.pntd.0010089",
language = "English",
volume = "16",
journal = "PLOS NEGLECT TROP D",
issn = "1935-2735",
publisher = "Public Library of Science",
number = "1",

}

RIS

TY - JOUR

T1 - A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever

AU - Olayinka, Adebola Tolulope

AU - Bourner, Josephine

AU - Akpede, George O

AU - Okoeguale, Joseph

AU - Abejegah, Chukwuyem

AU - Ajayi, Nnennaya A

AU - Akude, Christian

AU - Ayodeji, Oluwafemi

AU - Bausch, Daniel G

AU - de Clerck, Hilde

AU - Dan-Nwafor, Chioma

AU - Dunning, Jake

AU - Erameh, Cyril

AU - Eze, Justus Ndulue

AU - Formenty, Pierre

AU - Gillesen, Annelies

AU - Jalloh, Sulaiman

AU - Jaspard, Marie

AU - Jegede, Tolulope

AU - Maikere, Jacob

AU - Malvy, Denis

AU - Ogbaini-Emovon, Ephraim

AU - Ojo, Olalekan Ezekial

AU - Okogbenin, Sylvanus

AU - O'Neill, Kwame

AU - Orji, Maria-Lauretta

AU - Owhin, Sampson Omagbemi

AU - Ramharter, Michael

AU - Samuels, Robert J

AU - Shehu, Nathan

AU - Merson, Laura

AU - Salam, Alex Paddy

AU - Kayem, Nzelle Delphine

AU - Horby, Peter

AU - Ihekweazu, Chikwe

AU - Olliaro, Piero

PY - 2022/1

Y1 - 2022/1

N2 - BACKGROUND: 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.

AB - BACKGROUND: 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.

KW - Antiviral Agents/pharmacology

KW - Clinical Trials, Phase III as Topic/methods

KW - Drug Development/methods

KW - Drug Discovery/methods

KW - Humans

KW - Lassa Fever/drug therapy

KW - Lassa virus/drug effects

KW - Research Design

KW - Surveys and Questionnaires

U2 - 10.1371/journal.pntd.0010089

DO - 10.1371/journal.pntd.0010089

M3 - SCORING: Journal article

C2 - 34990453

VL - 16

JO - PLOS NEGLECT TROP D

JF - PLOS NEGLECT TROP D

SN - 1935-2735

IS - 1

M1 - e0010089

ER -