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Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective

Drug development in lupus has improved over the past 10 years but still lags behind that of other rheumatic disease areas. Assessment of prospective lupus therapies in clinical trials has proved challenging for reasons that are multifactorial including the heterogeneity of the disease, study design...

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Autores principales: Buie, Joy, Bloch, Lauren, Morand, Eric F, van Vollenhoven, Ronald F, Werth, Victoria P, Touma, Zahi, Lipsky, Peter, Kalunian, Kenneth, Askanase, Anca D, Ines, L, Reed, Christopher, Son, MaryBeth, Franson, Timothy, Costenbader, Karen, Schanberg, Laura Eve
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9930541/
https://www.ncbi.nlm.nih.gov/pubmed/37537705
http://dx.doi.org/10.1136/lupus-2023-000901
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author Buie, Joy
Bloch, Lauren
Morand, Eric F
van Vollenhoven, Ronald F
Werth, Victoria P
Touma, Zahi
Lipsky, Peter
Kalunian, Kenneth
Askanase, Anca D
Ines, L
Reed, Christopher
Son, MaryBeth
Franson, Timothy
Costenbader, Karen
Schanberg, Laura Eve
author_facet Buie, Joy
Bloch, Lauren
Morand, Eric F
van Vollenhoven, Ronald F
Werth, Victoria P
Touma, Zahi
Lipsky, Peter
Kalunian, Kenneth
Askanase, Anca D
Ines, L
Reed, Christopher
Son, MaryBeth
Franson, Timothy
Costenbader, Karen
Schanberg, Laura Eve
author_sort Buie, Joy
collection PubMed
description Drug development in lupus has improved over the past 10 years but still lags behind that of other rheumatic disease areas. Assessment of prospective lupus therapies in clinical trials has proved challenging for reasons that are multifactorial including the heterogeneity of the disease, study design limitations and a lack of validated biomarkers which greatly impacts regulatory decision-making. Moreover, most composite outcome measures currently used in trials do not include patient-reported outcomes. Given these factors, the Addressing Lupus Pillars for Health Advancement Global Advisory Committee members who serve on the drug development team identified an opportunity to convene a meeting to facilitate information sharing on completed and existing outcome measure development efforts. This meeting report highlights information presented during the meeting as well as a discussion on how the lupus community may work together with regulatory agencies to simplify and standardise outcome measures to accelerate development of lupus therapeutics.
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spelling pubmed-99305412023-02-16 Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective Buie, Joy Bloch, Lauren Morand, Eric F van Vollenhoven, Ronald F Werth, Victoria P Touma, Zahi Lipsky, Peter Kalunian, Kenneth Askanase, Anca D Ines, L Reed, Christopher Son, MaryBeth Franson, Timothy Costenbader, Karen Schanberg, Laura Eve Lupus Sci Med Meeting Report Drug development in lupus has improved over the past 10 years but still lags behind that of other rheumatic disease areas. Assessment of prospective lupus therapies in clinical trials has proved challenging for reasons that are multifactorial including the heterogeneity of the disease, study design limitations and a lack of validated biomarkers which greatly impacts regulatory decision-making. Moreover, most composite outcome measures currently used in trials do not include patient-reported outcomes. Given these factors, the Addressing Lupus Pillars for Health Advancement Global Advisory Committee members who serve on the drug development team identified an opportunity to convene a meeting to facilitate information sharing on completed and existing outcome measure development efforts. This meeting report highlights information presented during the meeting as well as a discussion on how the lupus community may work together with regulatory agencies to simplify and standardise outcome measures to accelerate development of lupus therapeutics. BMJ Publishing Group 2023-02-14 /pmc/articles/PMC9930541/ /pubmed/37537705 http://dx.doi.org/10.1136/lupus-2023-000901 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Meeting Report
Buie, Joy
Bloch, Lauren
Morand, Eric F
van Vollenhoven, Ronald F
Werth, Victoria P
Touma, Zahi
Lipsky, Peter
Kalunian, Kenneth
Askanase, Anca D
Ines, L
Reed, Christopher
Son, MaryBeth
Franson, Timothy
Costenbader, Karen
Schanberg, Laura Eve
Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective
title Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective
title_full Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective
title_fullStr Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective
title_full_unstemmed Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective
title_short Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective
title_sort meeting report: the alpha project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective
topic Meeting Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9930541/
https://www.ncbi.nlm.nih.gov/pubmed/37537705
http://dx.doi.org/10.1136/lupus-2023-000901
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