Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings.

<h4>Introduction</h4>The United States Food and Drug Administration (FDA) Gastrointestinal Drug Advisory Committee (GIDAC) is involved in gastrointestinal drug application reviews. Characteristics and conflicts of interest (COI) in GIDAC meetings are not well described. This study analyz...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Rishad Khan, Karam Elsolh, Nikko Gimpaya, Michael A Scaffidi, Rishi Bansal, Samir C Grover
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/f4fba966226b48adb7a4e44f6e42689c
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:f4fba966226b48adb7a4e44f6e42689c
record_format	dspace
spelling	oai:doaj.org-article:f4fba966226b48adb7a4e44f6e42689c2021-12-02T20:05:29ZCharacteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings.1932-620310.1371/journal.pone.0252155https://doaj.org/article/f4fba966226b48adb7a4e44f6e42689c2021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0252155https://doaj.org/toc/1932-6203<h4>Introduction</h4>The United States Food and Drug Administration (FDA) Gastrointestinal Drug Advisory Committee (GIDAC) is involved in gastrointestinal drug application reviews. Characteristics and conflicts of interest (COI) in GIDAC meetings are not well described. This study analyzed FDA GIDAC meetings and characteristics that predict recommendations.<h4>Methods</h4>In this cross-sectional study, all publicly available GIDAC meetings where proposed medications were voted on were included. Data were collected regarding indications, medication sponsor, primary efficacy studies, and voting member characteristics (e.g. committee membership, COI). Univariate analyses were conducted at per-meeting and per-vote levels to assess for predictors of committee recommendation and individual votes respectively.<h4>Results</h4>Thirty-four meetings with 476 individual votes from 1998-2018 were included. Twenty-three (68%) proposals were recommended for approval and 25 (74%) received FDA approval. Most proposals involved >1 primary study (n = 27, 79%). At least one voting member had a COI in 24 (71%) of 34 meetings. Twelve (35%) meetings had at least one sponsor COI. Among 476 individual votes, 74 (15.5%) involved a COI, with 33 (6.9%) sponsor COI. COI decreased significantly over time, with fewer COI in 2006-2010, 2011-2015, and 2016-2020 compared to 1996-2000 and 2001-2005 (p<0.01). There were no significant associations between pre-defined predictors, including COI, and committee level recommendations or individual votes (p>0.05 for all univariate analyses).<h4>Conclusions</h4>The GIDAC reviewed 34 proposals from 1998-2018. The majority were recommended for approval and later approved by the FDA, highlighting the GIDAC's prominence in the regulatory process. COI are present among GIDAC panelists but decreasing over time and not associated with recommendations.Rishad KhanKaram ElsolhNikko GimpayaMichael A ScaffidiRishi BansalSamir C GroverPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 5, p e0252155 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Rishad Khan Karam Elsolh Nikko Gimpaya Michael A Scaffidi Rishi Bansal Samir C Grover Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings.
description	<h4>Introduction</h4>The United States Food and Drug Administration (FDA) Gastrointestinal Drug Advisory Committee (GIDAC) is involved in gastrointestinal drug application reviews. Characteristics and conflicts of interest (COI) in GIDAC meetings are not well described. This study analyzed FDA GIDAC meetings and characteristics that predict recommendations.<h4>Methods</h4>In this cross-sectional study, all publicly available GIDAC meetings where proposed medications were voted on were included. Data were collected regarding indications, medication sponsor, primary efficacy studies, and voting member characteristics (e.g. committee membership, COI). Univariate analyses were conducted at per-meeting and per-vote levels to assess for predictors of committee recommendation and individual votes respectively.<h4>Results</h4>Thirty-four meetings with 476 individual votes from 1998-2018 were included. Twenty-three (68%) proposals were recommended for approval and 25 (74%) received FDA approval. Most proposals involved >1 primary study (n = 27, 79%). At least one voting member had a COI in 24 (71%) of 34 meetings. Twelve (35%) meetings had at least one sponsor COI. Among 476 individual votes, 74 (15.5%) involved a COI, with 33 (6.9%) sponsor COI. COI decreased significantly over time, with fewer COI in 2006-2010, 2011-2015, and 2016-2020 compared to 1996-2000 and 2001-2005 (p<0.01). There were no significant associations between pre-defined predictors, including COI, and committee level recommendations or individual votes (p>0.05 for all univariate analyses).<h4>Conclusions</h4>The GIDAC reviewed 34 proposals from 1998-2018. The majority were recommended for approval and later approved by the FDA, highlighting the GIDAC's prominence in the regulatory process. COI are present among GIDAC panelists but decreasing over time and not associated with recommendations.
format	article
author	Rishad Khan Karam Elsolh Nikko Gimpaya Michael A Scaffidi Rishi Bansal Samir C Grover
author_facet	Rishad Khan Karam Elsolh Nikko Gimpaya Michael A Scaffidi Rishi Bansal Samir C Grover
author_sort	Rishad Khan
title	Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings.
title_short	Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings.
title_full	Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings.
title_fullStr	Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings.
title_full_unstemmed	Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings.
title_sort	characteristics and conflicts of interest at food and drug administration gastrointestinal drug advisory committee meetings.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/f4fba966226b48adb7a4e44f6e42689c
work_keys_str_mv	AT rishadkhan characteristicsandconflictsofinterestatfoodanddrugadministrationgastrointestinaldrugadvisorycommitteemeetings AT karamelsolh characteristicsandconflictsofinterestatfoodanddrugadministrationgastrointestinaldrugadvisorycommitteemeetings AT nikkogimpaya characteristicsandconflictsofinterestatfoodanddrugadministrationgastrointestinaldrugadvisorycommitteemeetings AT michaelascaffidi characteristicsandconflictsofinterestatfoodanddrugadministrationgastrointestinaldrugadvisorycommitteemeetings AT rishibansal characteristicsandconflictsofinterestatfoodanddrugadministrationgastrointestinaldrugadvisorycommitteemeetings AT samircgrover characteristicsandconflictsofinterestatfoodanddrugadministrationgastrointestinaldrugadvisorycommitteemeetings
_version_	1718375518385995776

Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings.

Ejemplares similares