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Putting participants and study partners FIRST when clinical trials end early

Between 2018 and 2019, multiple clinical trials ended earlier than planned, resulting in calls to improve communication with and support for participants and their study partners (“dyads”). The multidisciplinary Participant Follow‐Up Improvement in Research Studies and Trials (Participant FIRST) Wor...

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Autores principales: Largent, Emily A., Walter, Sarah, Childs, Nancy, Dacks, Penny A., Dodge, Shana, Florian, Hana, Jackson, Jonathan, Llibre Guerra, Jorge J., Iturriaga, Erin, Miller, David S., Moreno, Monica, Nosheny, Rachel L., Obisesan, Thomas O., Portacolone, Elena, Siddiqi, Bernadette, Silverberg, Nina, Warren, Rueben C., Welsh‐Bohmer, Kathleen A., Edelmayer, Rebecca M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9926498/
https://www.ncbi.nlm.nih.gov/pubmed/35917209
http://dx.doi.org/10.1002/alz.12732
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author Largent, Emily A.
Walter, Sarah
Childs, Nancy
Dacks, Penny A.
Dodge, Shana
Florian, Hana
Jackson, Jonathan
Llibre Guerra, Jorge J.
Iturriaga, Erin
Miller, David S.
Moreno, Monica
Nosheny, Rachel L.
Obisesan, Thomas O.
Portacolone, Elena
Siddiqi, Bernadette
Silverberg, Nina
Warren, Rueben C.
Welsh‐Bohmer, Kathleen A.
Edelmayer, Rebecca M.
author_facet Largent, Emily A.
Walter, Sarah
Childs, Nancy
Dacks, Penny A.
Dodge, Shana
Florian, Hana
Jackson, Jonathan
Llibre Guerra, Jorge J.
Iturriaga, Erin
Miller, David S.
Moreno, Monica
Nosheny, Rachel L.
Obisesan, Thomas O.
Portacolone, Elena
Siddiqi, Bernadette
Silverberg, Nina
Warren, Rueben C.
Welsh‐Bohmer, Kathleen A.
Edelmayer, Rebecca M.
author_sort Largent, Emily A.
collection PubMed
description Between 2018 and 2019, multiple clinical trials ended earlier than planned, resulting in calls to improve communication with and support for participants and their study partners (“dyads”). The multidisciplinary Participant Follow‐Up Improvement in Research Studies and Trials (Participant FIRST) Work Group met throughout 2021. Its goals were to identify best practices for communicating with and supporting dyads affected by early trial stoppage. The Participant FIRST Work Group identified 17 key recommendations spanning the pre‐trial, mid‐trial, and post‐trial periods. These focus on prospectively allocating sufficient resources for orderly closeout; developing dyad‐centered communication plans; helping dyads build and maintain support networks; and, if a trial stops, informing dyads rapidly. Participants and study partners invest time, effort, and hope in their research participation. The research community should take intentional steps toward better communicating with and supporting participants when clinical trials end early. The Participant FIRST recommendations are a practical guide for embarking on that journey.
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spelling pubmed-99264982023-04-12 Putting participants and study partners FIRST when clinical trials end early Largent, Emily A. Walter, Sarah Childs, Nancy Dacks, Penny A. Dodge, Shana Florian, Hana Jackson, Jonathan Llibre Guerra, Jorge J. Iturriaga, Erin Miller, David S. Moreno, Monica Nosheny, Rachel L. Obisesan, Thomas O. Portacolone, Elena Siddiqi, Bernadette Silverberg, Nina Warren, Rueben C. Welsh‐Bohmer, Kathleen A. Edelmayer, Rebecca M. Alzheimers Dement Policy Forum Between 2018 and 2019, multiple clinical trials ended earlier than planned, resulting in calls to improve communication with and support for participants and their study partners (“dyads”). The multidisciplinary Participant Follow‐Up Improvement in Research Studies and Trials (Participant FIRST) Work Group met throughout 2021. Its goals were to identify best practices for communicating with and supporting dyads affected by early trial stoppage. The Participant FIRST Work Group identified 17 key recommendations spanning the pre‐trial, mid‐trial, and post‐trial periods. These focus on prospectively allocating sufficient resources for orderly closeout; developing dyad‐centered communication plans; helping dyads build and maintain support networks; and, if a trial stops, informing dyads rapidly. Participants and study partners invest time, effort, and hope in their research participation. The research community should take intentional steps toward better communicating with and supporting participants when clinical trials end early. The Participant FIRST recommendations are a practical guide for embarking on that journey. John Wiley and Sons Inc. 2022-08-02 2022-12 /pmc/articles/PMC9926498/ /pubmed/35917209 http://dx.doi.org/10.1002/alz.12732 Text en © 2022 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Policy Forum
Largent, Emily A.
Walter, Sarah
Childs, Nancy
Dacks, Penny A.
Dodge, Shana
Florian, Hana
Jackson, Jonathan
Llibre Guerra, Jorge J.
Iturriaga, Erin
Miller, David S.
Moreno, Monica
Nosheny, Rachel L.
Obisesan, Thomas O.
Portacolone, Elena
Siddiqi, Bernadette
Silverberg, Nina
Warren, Rueben C.
Welsh‐Bohmer, Kathleen A.
Edelmayer, Rebecca M.
Putting participants and study partners FIRST when clinical trials end early
title Putting participants and study partners FIRST when clinical trials end early
title_full Putting participants and study partners FIRST when clinical trials end early
title_fullStr Putting participants and study partners FIRST when clinical trials end early
title_full_unstemmed Putting participants and study partners FIRST when clinical trials end early
title_short Putting participants and study partners FIRST when clinical trials end early
title_sort putting participants and study partners first when clinical trials end early
topic Policy Forum
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9926498/
https://www.ncbi.nlm.nih.gov/pubmed/35917209
http://dx.doi.org/10.1002/alz.12732
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