A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever.
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 meth...
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ftdoajarticles:oai:doaj.org/article:b60018e400ac4403b5581934cbaa9fe3 2023-05-15T15:13:32+02:00 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 Chioma Dan-Nwafor Jake Dunning Cyril Erameh Justus Ndulue Eze Pierre Formenty Annelies Gillesen Sulaiman Jalloh Marie Jaspard Tolulope Jegede Jacob Maikere Denis Malvy Ephraim Ogbaini-Emovon Olalekan Ezekial Ojo Sylvanus Okogbenin Kwame O'Neill Maria-Lauretta Orji Sampson Omagbemi Owhin Michael Ramharter Robert J Samuels Nathan Shehu Laura Merson Alex Paddy Salam Nzelle Delphine Kayem Peter Horby Chikwe Ihekweazu Piero Olliaro 2022-01-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0010089 https://doaj.org/article/b60018e400ac4403b5581934cbaa9fe3 EN eng Public Library of Science (PLoS) https://doi.org/10.1371/journal.pntd.0010089 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0010089 https://doaj.org/article/b60018e400ac4403b5581934cbaa9fe3 PLoS Neglected Tropical Diseases, Vol 16, Iss 1, p e0010089 (2022) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2022 ftdoajarticles https://doi.org/10.1371/journal.pntd.0010089 2022-12-31T13:45:45Z 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. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLOS Neglected Tropical Diseases 16 1 e0010089 |
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Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
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English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 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 Chioma Dan-Nwafor Jake Dunning Cyril Erameh Justus Ndulue Eze Pierre Formenty Annelies Gillesen Sulaiman Jalloh Marie Jaspard Tolulope Jegede Jacob Maikere Denis Malvy Ephraim Ogbaini-Emovon Olalekan Ezekial Ojo Sylvanus Okogbenin Kwame O'Neill Maria-Lauretta Orji Sampson Omagbemi Owhin Michael Ramharter Robert J Samuels Nathan Shehu Laura Merson Alex Paddy Salam Nzelle Delphine Kayem Peter Horby Chikwe Ihekweazu Piero Olliaro A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
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. |
format |
Article in Journal/Newspaper |
author |
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 Chioma Dan-Nwafor Jake Dunning Cyril Erameh Justus Ndulue Eze Pierre Formenty Annelies Gillesen Sulaiman Jalloh Marie Jaspard Tolulope Jegede Jacob Maikere Denis Malvy Ephraim Ogbaini-Emovon Olalekan Ezekial Ojo Sylvanus Okogbenin Kwame O'Neill Maria-Lauretta Orji Sampson Omagbemi Owhin Michael Ramharter Robert J Samuels Nathan Shehu Laura Merson Alex Paddy Salam Nzelle Delphine Kayem Peter Horby Chikwe Ihekweazu Piero Olliaro |
author_facet |
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 Chioma Dan-Nwafor Jake Dunning Cyril Erameh Justus Ndulue Eze Pierre Formenty Annelies Gillesen Sulaiman Jalloh Marie Jaspard Tolulope Jegede Jacob Maikere Denis Malvy Ephraim Ogbaini-Emovon Olalekan Ezekial Ojo Sylvanus Okogbenin Kwame O'Neill Maria-Lauretta Orji Sampson Omagbemi Owhin Michael Ramharter Robert J Samuels Nathan Shehu Laura Merson Alex Paddy Salam Nzelle Delphine Kayem Peter Horby Chikwe Ihekweazu Piero Olliaro |
author_sort |
Adebola Tolulope Olayinka |
title |
A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever. |
title_short |
A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever. |
title_full |
A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever. |
title_fullStr |
A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever. |
title_full_unstemmed |
A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever. |
title_sort |
standardised phase iii clinical trial framework to assess therapeutic interventions for lassa fever. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2022 |
url |
https://doi.org/10.1371/journal.pntd.0010089 https://doaj.org/article/b60018e400ac4403b5581934cbaa9fe3 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 16, Iss 1, p e0010089 (2022) |
op_relation |
https://doi.org/10.1371/journal.pntd.0010089 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0010089 https://doaj.org/article/b60018e400ac4403b5581934cbaa9fe3 |
op_doi |
https://doi.org/10.1371/journal.pntd.0010089 |
container_title |
PLOS Neglected Tropical Diseases |
container_volume |
16 |
container_issue |
1 |
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e0010089 |
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