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Patient advocacy organizations’ information for patients on pre-approval access to investigational treatments

OBJECTIVE: To evaluate the availability of information regarding patient access to investigational treatments through clinical trials and non-trial pre-approval access pathways from a sample of patient advocacy organization (PAO) websites in the United States. RESULTS: We systematically analyzed the...

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Autores principales: Folkers, Kelly McBride, Leone, Sarah, Caplan, Arthur
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6819417/
https://www.ncbi.nlm.nih.gov/pubmed/31661023
http://dx.doi.org/10.1186/s13104-019-4745-7
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author Folkers, Kelly McBride
Leone, Sarah
Caplan, Arthur
author_facet Folkers, Kelly McBride
Leone, Sarah
Caplan, Arthur
author_sort Folkers, Kelly McBride
collection PubMed
description OBJECTIVE: To evaluate the availability of information regarding patient access to investigational treatments through clinical trials and non-trial pre-approval access pathways from a sample of patient advocacy organization (PAO) websites in the United States. RESULTS: We systematically analyzed the content of 118 randomly selected PAO websites to assess whether they contained information on clinical trials and non-trial pathways—e.g., the U.S. Food and Drug Administration (FDA) expanded access (EA) program and right to try—over the course of two months from February to March 2019. A majority (81%, n = 96) of PAOs provided a link to ClinicalTrials.gov, and 73% (n = 86) had their own clinical trial finder or list of relevant trials. 23% (n = 27) mentioned EA, with 8% (n = 9) providing specific resources for FDA’s EA program. 8% (n = 10) provided a statement on the passage of the federal right to try law. A majority of PAO websites contained information on clinical trials, but a minority discussed non-trial pre-approval access. The lack of information on the latter highlights an area in need of improvement.
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spelling pubmed-68194172019-10-31 Patient advocacy organizations’ information for patients on pre-approval access to investigational treatments Folkers, Kelly McBride Leone, Sarah Caplan, Arthur BMC Res Notes Research Note OBJECTIVE: To evaluate the availability of information regarding patient access to investigational treatments through clinical trials and non-trial pre-approval access pathways from a sample of patient advocacy organization (PAO) websites in the United States. RESULTS: We systematically analyzed the content of 118 randomly selected PAO websites to assess whether they contained information on clinical trials and non-trial pathways—e.g., the U.S. Food and Drug Administration (FDA) expanded access (EA) program and right to try—over the course of two months from February to March 2019. A majority (81%, n = 96) of PAOs provided a link to ClinicalTrials.gov, and 73% (n = 86) had their own clinical trial finder or list of relevant trials. 23% (n = 27) mentioned EA, with 8% (n = 9) providing specific resources for FDA’s EA program. 8% (n = 10) provided a statement on the passage of the federal right to try law. A majority of PAO websites contained information on clinical trials, but a minority discussed non-trial pre-approval access. The lack of information on the latter highlights an area in need of improvement. BioMed Central 2019-10-28 /pmc/articles/PMC6819417/ /pubmed/31661023 http://dx.doi.org/10.1186/s13104-019-4745-7 Text en © The Author(s) 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Note
Folkers, Kelly McBride
Leone, Sarah
Caplan, Arthur
Patient advocacy organizations’ information for patients on pre-approval access to investigational treatments
title Patient advocacy organizations’ information for patients on pre-approval access to investigational treatments
title_full Patient advocacy organizations’ information for patients on pre-approval access to investigational treatments
title_fullStr Patient advocacy organizations’ information for patients on pre-approval access to investigational treatments
title_full_unstemmed Patient advocacy organizations’ information for patients on pre-approval access to investigational treatments
title_short Patient advocacy organizations’ information for patients on pre-approval access to investigational treatments
title_sort patient advocacy organizations’ information for patients on pre-approval access to investigational treatments
topic Research Note
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6819417/
https://www.ncbi.nlm.nih.gov/pubmed/31661023
http://dx.doi.org/10.1186/s13104-019-4745-7
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