Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation.
Progress with the treatment of cutaneous leishmaniasis (CL) has been hampered by inconsistent methodologies used to assess treatment effects. A sizable number of trials conducted over the years has generated only weak evidence backing current treatment recommendations, as shown by systematic reviews...
Published in: | PLOS Neglected Tropical Diseases |
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Online Access: | https://doi.org/10.1371/journal.pntd.0006141 https://doaj.org/article/ef3ff102cf1848f5a91bb95d75b6865e |
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ftdoajarticles:oai:doaj.org/article:ef3ff102cf1848f5a91bb95d75b6865e 2023-05-15T15:07:47+02:00 Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation. Piero Olliaro Max Grogl Marina Boni Edgar M Carvalho Houda Chebli Mamoudou Cisse Ermias Diro Gláucia Fernandes Cota Astrid C Erber Endalamaw Gadisa Farhad Handjani Ali Khamesipour Alejandro Llanos-Cuentas Liliana López Carvajal Lise Grout Badre Eddine Lmimouni Mourad Mokni Mohammad Sami Nahzat Afif Ben Salah Yusuf Ozbel Juan Miguel Pascale Nidia Rizzo Molina Joelle Rode Gustavo Romero José Antonio Ruiz-Postigo Nancy Gore Saravia Jaime Soto Soner Uzun Vahid Mashayekhi Ivan Dario Vélez Florian Vogt Olga Zerpa Byron Arana 2018-01-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0006141 https://doaj.org/article/ef3ff102cf1848f5a91bb95d75b6865e EN eng Public Library of Science (PLoS) http://europepmc.org/articles/PMC5785032?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0006141 https://doaj.org/article/ef3ff102cf1848f5a91bb95d75b6865e PLoS Neglected Tropical Diseases, Vol 12, Iss 1, p e0006141 (2018) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2018 ftdoajarticles https://doi.org/10.1371/journal.pntd.0006141 2022-12-31T00:20:12Z Progress with the treatment of cutaneous leishmaniasis (CL) has been hampered by inconsistent methodologies used to assess treatment effects. A sizable number of trials conducted over the years has generated only weak evidence backing current treatment recommendations, as shown by systematic reviews on old-world and new-world CL (OWCL and NWCL).Using a previously published guidance paper on CL treatment trial methodology as the reference, consensus was sought on key parameters including core eligibility and outcome measures, among OWCL (7 countries, 10 trial sites) and NWCL (7 countries, 11 trial sites) during two separate meetings.Findings and level of consensus within and between OWCL and NWCL sites are presented and discussed. In addition, CL trial site characteristics and capacities are summarized.The consensus reached allows standardization of future clinical research across OWCL and NWCL sites. We encourage CL researchers to adopt and adapt as required the proposed parameters and outcomes in their future trials and provide feedback on their experience. The expertise afforded between the two sets of clinical sites provides the basis for a powerful consortium with potential for extensive, standardized assessment of interventions for CL and faster approval of candidate treatments. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLOS Neglected Tropical Diseases 12 1 e0006141 |
institution |
Open Polar |
collection |
Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
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 Piero Olliaro Max Grogl Marina Boni Edgar M Carvalho Houda Chebli Mamoudou Cisse Ermias Diro Gláucia Fernandes Cota Astrid C Erber Endalamaw Gadisa Farhad Handjani Ali Khamesipour Alejandro Llanos-Cuentas Liliana López Carvajal Lise Grout Badre Eddine Lmimouni Mourad Mokni Mohammad Sami Nahzat Afif Ben Salah Yusuf Ozbel Juan Miguel Pascale Nidia Rizzo Molina Joelle Rode Gustavo Romero José Antonio Ruiz-Postigo Nancy Gore Saravia Jaime Soto Soner Uzun Vahid Mashayekhi Ivan Dario Vélez Florian Vogt Olga Zerpa Byron Arana Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
Progress with the treatment of cutaneous leishmaniasis (CL) has been hampered by inconsistent methodologies used to assess treatment effects. A sizable number of trials conducted over the years has generated only weak evidence backing current treatment recommendations, as shown by systematic reviews on old-world and new-world CL (OWCL and NWCL).Using a previously published guidance paper on CL treatment trial methodology as the reference, consensus was sought on key parameters including core eligibility and outcome measures, among OWCL (7 countries, 10 trial sites) and NWCL (7 countries, 11 trial sites) during two separate meetings.Findings and level of consensus within and between OWCL and NWCL sites are presented and discussed. In addition, CL trial site characteristics and capacities are summarized.The consensus reached allows standardization of future clinical research across OWCL and NWCL sites. We encourage CL researchers to adopt and adapt as required the proposed parameters and outcomes in their future trials and provide feedback on their experience. The expertise afforded between the two sets of clinical sites provides the basis for a powerful consortium with potential for extensive, standardized assessment of interventions for CL and faster approval of candidate treatments. |
format |
Article in Journal/Newspaper |
author |
Piero Olliaro Max Grogl Marina Boni Edgar M Carvalho Houda Chebli Mamoudou Cisse Ermias Diro Gláucia Fernandes Cota Astrid C Erber Endalamaw Gadisa Farhad Handjani Ali Khamesipour Alejandro Llanos-Cuentas Liliana López Carvajal Lise Grout Badre Eddine Lmimouni Mourad Mokni Mohammad Sami Nahzat Afif Ben Salah Yusuf Ozbel Juan Miguel Pascale Nidia Rizzo Molina Joelle Rode Gustavo Romero José Antonio Ruiz-Postigo Nancy Gore Saravia Jaime Soto Soner Uzun Vahid Mashayekhi Ivan Dario Vélez Florian Vogt Olga Zerpa Byron Arana |
author_facet |
Piero Olliaro Max Grogl Marina Boni Edgar M Carvalho Houda Chebli Mamoudou Cisse Ermias Diro Gláucia Fernandes Cota Astrid C Erber Endalamaw Gadisa Farhad Handjani Ali Khamesipour Alejandro Llanos-Cuentas Liliana López Carvajal Lise Grout Badre Eddine Lmimouni Mourad Mokni Mohammad Sami Nahzat Afif Ben Salah Yusuf Ozbel Juan Miguel Pascale Nidia Rizzo Molina Joelle Rode Gustavo Romero José Antonio Ruiz-Postigo Nancy Gore Saravia Jaime Soto Soner Uzun Vahid Mashayekhi Ivan Dario Vélez Florian Vogt Olga Zerpa Byron Arana |
author_sort |
Piero Olliaro |
title |
Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation. |
title_short |
Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation. |
title_full |
Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation. |
title_fullStr |
Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation. |
title_full_unstemmed |
Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation. |
title_sort |
harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2018 |
url |
https://doi.org/10.1371/journal.pntd.0006141 https://doaj.org/article/ef3ff102cf1848f5a91bb95d75b6865e |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 12, Iss 1, p e0006141 (2018) |
op_relation |
http://europepmc.org/articles/PMC5785032?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0006141 https://doaj.org/article/ef3ff102cf1848f5a91bb95d75b6865e |
op_doi |
https://doi.org/10.1371/journal.pntd.0006141 |
container_title |
PLOS Neglected Tropical Diseases |
container_volume |
12 |
container_issue |
1 |
container_start_page |
e0006141 |
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1766339206191251456 |