Cargando…
Regulatory oversight on the use of experimental therapies during a pandemic: The case of early access to convalescent plasma therapy in three LMICs
Clinicians, especially in low- and middle-income countries (LMICs), contend with limited economic and healthcare resources in deciding appropriate and feasible care for their patients. Some of the LMICs affected by COVID-19 implemented convalescent plasma therapy without sufficient regulatory guidan...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The Author(s). Published by Elsevier Ltd.
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8664719/ https://www.ncbi.nlm.nih.gov/pubmed/34906688 http://dx.doi.org/10.1016/j.drudis.2021.12.002 |
_version_ | 1784613902947975168 |
---|---|
author | Bernabe, Rosemarie Torres, Cristina Wangge, Grace Jimenez, Edlyn Karbwang, Juntra |
author_facet | Bernabe, Rosemarie Torres, Cristina Wangge, Grace Jimenez, Edlyn Karbwang, Juntra |
author_sort | Bernabe, Rosemarie |
collection | PubMed |
description | Clinicians, especially in low- and middle-income countries (LMICs), contend with limited economic and healthcare resources in deciding appropriate and feasible care for their patients. Some of the LMICs affected by COVID-19 implemented convalescent plasma therapy without sufficient regulatory guidance. Based on this experience, there are several requirements going forward, including: the need for an immediately accessible data gathering and processing system; the necessity of establishing regulatory pathways for early access to experimental treatment during emergency situations; and the accompanying reporting and monitoring requirements must be set. The different stakeholders must also be properly incorporated in the system that such a pathway will create, without neglecting to properly inform the public of the patient rights especially during an emergency situation. |
format | Online Article Text |
id | pubmed-8664719 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | The Author(s). Published by Elsevier Ltd. |
record_format | MEDLINE/PubMed |
spelling | pubmed-86647192021-12-14 Regulatory oversight on the use of experimental therapies during a pandemic: The case of early access to convalescent plasma therapy in three LMICs Bernabe, Rosemarie Torres, Cristina Wangge, Grace Jimenez, Edlyn Karbwang, Juntra Drug Discov Today Feature Clinicians, especially in low- and middle-income countries (LMICs), contend with limited economic and healthcare resources in deciding appropriate and feasible care for their patients. Some of the LMICs affected by COVID-19 implemented convalescent plasma therapy without sufficient regulatory guidance. Based on this experience, there are several requirements going forward, including: the need for an immediately accessible data gathering and processing system; the necessity of establishing regulatory pathways for early access to experimental treatment during emergency situations; and the accompanying reporting and monitoring requirements must be set. The different stakeholders must also be properly incorporated in the system that such a pathway will create, without neglecting to properly inform the public of the patient rights especially during an emergency situation. The Author(s). Published by Elsevier Ltd. 2022-03 2021-12-11 /pmc/articles/PMC8664719/ /pubmed/34906688 http://dx.doi.org/10.1016/j.drudis.2021.12.002 Text en © 2021 The Author(s) Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Feature Bernabe, Rosemarie Torres, Cristina Wangge, Grace Jimenez, Edlyn Karbwang, Juntra Regulatory oversight on the use of experimental therapies during a pandemic: The case of early access to convalescent plasma therapy in three LMICs |
title | Regulatory oversight on the use of experimental therapies during a pandemic: The case of early access to convalescent plasma therapy in three LMICs |
title_full | Regulatory oversight on the use of experimental therapies during a pandemic: The case of early access to convalescent plasma therapy in three LMICs |
title_fullStr | Regulatory oversight on the use of experimental therapies during a pandemic: The case of early access to convalescent plasma therapy in three LMICs |
title_full_unstemmed | Regulatory oversight on the use of experimental therapies during a pandemic: The case of early access to convalescent plasma therapy in three LMICs |
title_short | Regulatory oversight on the use of experimental therapies during a pandemic: The case of early access to convalescent plasma therapy in three LMICs |
title_sort | regulatory oversight on the use of experimental therapies during a pandemic: the case of early access to convalescent plasma therapy in three lmics |
topic | Feature |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8664719/ https://www.ncbi.nlm.nih.gov/pubmed/34906688 http://dx.doi.org/10.1016/j.drudis.2021.12.002 |
work_keys_str_mv | AT bernaberosemarie regulatoryoversightontheuseofexperimentaltherapiesduringapandemicthecaseofearlyaccesstoconvalescentplasmatherapyinthreelmics AT torrescristina regulatoryoversightontheuseofexperimentaltherapiesduringapandemicthecaseofearlyaccesstoconvalescentplasmatherapyinthreelmics AT wanggegrace regulatoryoversightontheuseofexperimentaltherapiesduringapandemicthecaseofearlyaccesstoconvalescentplasmatherapyinthreelmics AT jimenezedlyn regulatoryoversightontheuseofexperimentaltherapiesduringapandemicthecaseofearlyaccesstoconvalescentplasmatherapyinthreelmics AT karbwangjuntra regulatoryoversightontheuseofexperimentaltherapiesduringapandemicthecaseofearlyaccesstoconvalescentplasmatherapyinthreelmics |