Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings
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 charact...
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| description | 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. 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. 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 (p0.05 for all univariate analyses). 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. |
| doi_str_mv | 10.1371/journal.pone.0252155 |
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Characteristics and conflicts of interest (COI) in GIDAC meetings are not well described. This study analyzed FDA GIDAC meetings and characteristics that predict recommendations. 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. 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 (p0.05 for all univariate analyses). 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.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0252155</identifier><identifier>PMID: 34038480</identifier><language>eng</language><publisher>San Francisco: Public Library of Science</publisher><subject>Analysis ; Canada, Michael ; Clinical trials ; Committees ; Conflict of interests (Agency) ; Conflicts of interest ; Corporate sponsorship ; Data collection ; Drafting software ; Drug approval ; Editing ; FDA approval ; Gastroenterology ; Gastrointestinal agents ; Hospitals ; Inflammatory bowel disease ; Inflammatory bowel diseases ; Licenses ; Licensing, certification and accreditation ; Medicine ; Medicine and Health Sciences ; Meetings ; Methodology ; Pharmaceutical industry ; Regulatory agencies ; Research and analysis methods ; Reviews ; Science Policy ; Social Sciences ; Statistical analysis ; Subgroups</subject><ispartof>PloS one, 2021-05, Vol.16 (5), p.e0252155-e0252155</ispartof><rights>COPYRIGHT 2021 Public Library of Science</rights><rights>2021 Khan et al. 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Characteristics and conflicts of interest (COI) in GIDAC meetings are not well described. This study analyzed FDA GIDAC meetings and characteristics that predict recommendations. 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. 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 (p0.05 for all univariate analyses). 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. 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one</jtitle><date>2021-05-26</date><risdate>2021</risdate><volume>16</volume><issue>5</issue><spage>e0252155</spage><epage>e0252155</epage><pages>e0252155-e0252155</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>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. 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. 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 (p0.05 for all univariate analyses). 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.</abstract><cop>San Francisco</cop><pub>Public Library of Science</pub><pmid>34038480</pmid><doi>10.1371/journal.pone.0252155</doi><tpages>e0252155</tpages><orcidid>https://orcid.org/0000-0003-2068-6655</orcidid><orcidid>https://orcid.org/0000-0003-1015-4372</orcidid><orcidid>https://orcid.org/0000-0002-5090-7685</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Analysis Canada, Michael Clinical trials Committees Conflict of interests (Agency) Conflicts of interest Corporate sponsorship Data collection Drafting software Drug approval Editing FDA approval Gastroenterology Gastrointestinal agents Hospitals Inflammatory bowel disease Inflammatory bowel diseases Licenses Licensing, certification and accreditation Medicine Medicine and Health Sciences Meetings Methodology Pharmaceutical industry Regulatory agencies Research and analysis methods Reviews Science Policy Social Sciences Statistical analysis Subgroups |
| title | Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings |
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