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Trends in clinical trial investigator workforce and turnover: An analysis of the U.S. FDA 1572 BMIS database

BACKGROUND: High turnover rates among clinical trial investigators contribute to inefficiency, instability, and increased costs for the clinical research enterprise; however, factors contributing to investigator turnover have not been well characterized. METHODS: Using information from the U.S. Food...

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Autores principales: Fordyce, Christopher B., Roe, Matthew T., Pierre, Christine, Hinkley, Terri, Hamre, Gerrit, Tenaerts, Pamela, McCall, Jonathan, Topping, James D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6536616/
https://www.ncbi.nlm.nih.gov/pubmed/31193608
http://dx.doi.org/10.1016/j.conctc.2019.100380
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author Fordyce, Christopher B.
Roe, Matthew T.
Pierre, Christine
Hinkley, Terri
Hamre, Gerrit
Tenaerts, Pamela
McCall, Jonathan
Topping, James D.
author_facet Fordyce, Christopher B.
Roe, Matthew T.
Pierre, Christine
Hinkley, Terri
Hamre, Gerrit
Tenaerts, Pamela
McCall, Jonathan
Topping, James D.
author_sort Fordyce, Christopher B.
collection PubMed
description BACKGROUND: High turnover rates among clinical trial investigators contribute to inefficiency, instability, and increased costs for the clinical research enterprise; however, factors contributing to investigator turnover have not been well characterized. METHODS: Using information from the U.S. Food and Drug Administration's Bioresearch Monitoring Information System (BMIS), we examined trends in the overall clinical investigator workforce and within specific “phenotypes” as well as differences by investigator location (U.S.-based vs. non-U.S.-based). We identified unique investigators within the database, stratifying them into one of three “phenotypes”: those with one Form FDA1572 submission across the study interval (“one-and-done”); those with two or more submissions but with substantial intervals between trials (“stop-and-go”); and those with two or more submissions and continuous involvement in multiple trials (“stayers”). RESULTS: Of the 172,453 unique investigators who submitted a Form FDA 1572 during the study interval (1999–2015), 85,455 were classified as “one-and-done” investigators; 21,768 as “stop-and-go” investigators; and 65,231 as “stayer” investigators. The total number of investigators declined across the study interval. Among all subgroups, only “one-and-done” investigators showed growth across the study period, largely driven by increases in non-U.S.-based investigators. “Stop-and-go” investigators showed declines for both U.S.-based and non-U.S.-based investigators, as did “stayers,” who showed the largest absolute and proportional declines of all subgroups. CONCLUSIONS: From 1999 to 2015, investigators submitting a Form FDA 1572 to the BMIS database declined by approximately one-third and the proportion of investigators involved in only one trial increased, signaling potential adverse trends in the clinical investigator workforce. Strategies for sustaining investigator engagement warrant further exploration.
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spelling pubmed-65366162019-05-30 Trends in clinical trial investigator workforce and turnover: An analysis of the U.S. FDA 1572 BMIS database Fordyce, Christopher B. Roe, Matthew T. Pierre, Christine Hinkley, Terri Hamre, Gerrit Tenaerts, Pamela McCall, Jonathan Topping, James D. Contemp Clin Trials Commun Article BACKGROUND: High turnover rates among clinical trial investigators contribute to inefficiency, instability, and increased costs for the clinical research enterprise; however, factors contributing to investigator turnover have not been well characterized. METHODS: Using information from the U.S. Food and Drug Administration's Bioresearch Monitoring Information System (BMIS), we examined trends in the overall clinical investigator workforce and within specific “phenotypes” as well as differences by investigator location (U.S.-based vs. non-U.S.-based). We identified unique investigators within the database, stratifying them into one of three “phenotypes”: those with one Form FDA1572 submission across the study interval (“one-and-done”); those with two or more submissions but with substantial intervals between trials (“stop-and-go”); and those with two or more submissions and continuous involvement in multiple trials (“stayers”). RESULTS: Of the 172,453 unique investigators who submitted a Form FDA 1572 during the study interval (1999–2015), 85,455 were classified as “one-and-done” investigators; 21,768 as “stop-and-go” investigators; and 65,231 as “stayer” investigators. The total number of investigators declined across the study interval. Among all subgroups, only “one-and-done” investigators showed growth across the study period, largely driven by increases in non-U.S.-based investigators. “Stop-and-go” investigators showed declines for both U.S.-based and non-U.S.-based investigators, as did “stayers,” who showed the largest absolute and proportional declines of all subgroups. CONCLUSIONS: From 1999 to 2015, investigators submitting a Form FDA 1572 to the BMIS database declined by approximately one-third and the proportion of investigators involved in only one trial increased, signaling potential adverse trends in the clinical investigator workforce. Strategies for sustaining investigator engagement warrant further exploration. Elsevier 2019-05-21 /pmc/articles/PMC6536616/ /pubmed/31193608 http://dx.doi.org/10.1016/j.conctc.2019.100380 Text en © 2019 The Authors http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Fordyce, Christopher B.
Roe, Matthew T.
Pierre, Christine
Hinkley, Terri
Hamre, Gerrit
Tenaerts, Pamela
McCall, Jonathan
Topping, James D.
Trends in clinical trial investigator workforce and turnover: An analysis of the U.S. FDA 1572 BMIS database
title Trends in clinical trial investigator workforce and turnover: An analysis of the U.S. FDA 1572 BMIS database
title_full Trends in clinical trial investigator workforce and turnover: An analysis of the U.S. FDA 1572 BMIS database
title_fullStr Trends in clinical trial investigator workforce and turnover: An analysis of the U.S. FDA 1572 BMIS database
title_full_unstemmed Trends in clinical trial investigator workforce and turnover: An analysis of the U.S. FDA 1572 BMIS database
title_short Trends in clinical trial investigator workforce and turnover: An analysis of the U.S. FDA 1572 BMIS database
title_sort trends in clinical trial investigator workforce and turnover: an analysis of the u.s. fda 1572 bmis database
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6536616/
https://www.ncbi.nlm.nih.gov/pubmed/31193608
http://dx.doi.org/10.1016/j.conctc.2019.100380
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