Changes in key recruitment performance metrics from 2008-2019 in industrysponsored phase III clinical trials registered at ClinicalTrials.gov

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

Standard

Changes in key recruitment performance metrics from 2008-2019 in industrysponsored phase III clinical trials registered at ClinicalTrials.gov. / Brøgger-Mikkelsen, Mette; Zibert, John Robert; Andersen, Anders Daniel; Lassen, Ulrik; Hædersdal, Merete; Ali, Zarqa; Thomsen, Simon Francis.

I: PLoS ONE, Bind 17, Nr. 7 July, e0271819, 2022, s. 1-15.

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

Harvard

Brøgger-Mikkelsen, M, Zibert, JR, Andersen, AD, Lassen, U, Hædersdal, M, Ali, Z & Thomsen, SF 2022, 'Changes in key recruitment performance metrics from 2008-2019 in industrysponsored phase III clinical trials registered at ClinicalTrials.gov', PLoS ONE, bind 17, nr. 7 July, e0271819, s. 1-15. https://doi.org/10.1371/journal.pone.0271819

APA

Brøgger-Mikkelsen, M., Zibert, J. R., Andersen, A. D., Lassen, U., Hædersdal, M., Ali, Z., & Thomsen, S. F. (2022). Changes in key recruitment performance metrics from 2008-2019 in industrysponsored phase III clinical trials registered at ClinicalTrials.gov. PLoS ONE, 17(7 July), 1-15. [e0271819]. https://doi.org/10.1371/journal.pone.0271819

Vancouver

Brøgger-Mikkelsen M, Zibert JR, Andersen AD, Lassen U, Hædersdal M, Ali Z o.a. Changes in key recruitment performance metrics from 2008-2019 in industrysponsored phase III clinical trials registered at ClinicalTrials.gov. PLoS ONE. 2022;17(7 July):1-15. e0271819. https://doi.org/10.1371/journal.pone.0271819

Author

Brøgger-Mikkelsen, Mette ; Zibert, John Robert ; Andersen, Anders Daniel ; Lassen, Ulrik ; Hædersdal, Merete ; Ali, Zarqa ; Thomsen, Simon Francis. / Changes in key recruitment performance metrics from 2008-2019 in industrysponsored phase III clinical trials registered at ClinicalTrials.gov. I: PLoS ONE. 2022 ; Bind 17, Nr. 7 July. s. 1-15.

Bibtex

@article{f59257b5d48543938a3b5f99daa2c0e0,
title = "Changes in key recruitment performance metrics from 2008-2019 in industrysponsored phase III clinical trials registered at ClinicalTrials.gov",
abstract = "Background Increasing costs and complexity in clinical trials requires recruitment of more narrowly defined patient populations. However, recruitment for clinical trials remains a considerable challenge. Aim Our overall aim was to quantify recruitment performance in industry-sponsored phase III clinical trials conducted globally during 2008-2019 with primary aim to examine development of overall clinical trial measures (number of trials completed, number of participants enrolled, trial duration in months) and key recruitment metrics (recruitment rate, number of sites, number of patients enrolled per site). Methods The publicly available AACT database containing data on all trials registered at Clinical-Trials.gov since 2008 was used. The analysis was completed during three time periods from 2008-2019 of 4 years each. Results and conclusion Recruitment duration for industry-sponsored phase III clinical trials have increased significantly during the last 12 years from an average recruitment period of 13 months (IQR 7-23) in 2008-2011 to 18 months (IQR 11-28) in 2016-2019 (p = 0.0068). Further, phase III clinical trials have increased the number of registered sites per clinical trial by more than 30% during the last 12 years from a median number 43 sites (IQR 17-84) in 2012-2015 to 64 sites (IQR 30-118) in 2016-2019 (p = 0.025), and concurrently, the number of participants enrolled in clinical research has decreased significantly from 2012-2015 and 2016-2019 (p = 0.046). We believe that these findings indicate that recruitment for phase III clinical trials is less effective today compared to 12 years ago.",
author = "Mette Br{\o}gger-Mikkelsen and Zibert, {John Robert} and Andersen, {Anders Daniel} and Ulrik Lassen and Merete H{\ae}dersdal and Zarqa Ali and Thomsen, {Simon Francis}",
note = "Publisher Copyright: {\textcopyright} 2022 Br{\o}gger-Mikkelsen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.",
year = "2022",
doi = "10.1371/journal.pone.0271819",
language = "English",
volume = "17",
pages = "1--15",
journal = "PLoS ONE",
issn = "1932-6203",
publisher = "Public Library of Science",
number = "7 July",

}

RIS

TY - JOUR

T1 - Changes in key recruitment performance metrics from 2008-2019 in industrysponsored phase III clinical trials registered at ClinicalTrials.gov

AU - Brøgger-Mikkelsen, Mette

AU - Zibert, John Robert

AU - Andersen, Anders Daniel

AU - Lassen, Ulrik

AU - Hædersdal, Merete

AU - Ali, Zarqa

AU - Thomsen, Simon Francis

N1 - Publisher Copyright: © 2022 Brøgger-Mikkelsen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

PY - 2022

Y1 - 2022

N2 - Background Increasing costs and complexity in clinical trials requires recruitment of more narrowly defined patient populations. However, recruitment for clinical trials remains a considerable challenge. Aim Our overall aim was to quantify recruitment performance in industry-sponsored phase III clinical trials conducted globally during 2008-2019 with primary aim to examine development of overall clinical trial measures (number of trials completed, number of participants enrolled, trial duration in months) and key recruitment metrics (recruitment rate, number of sites, number of patients enrolled per site). Methods The publicly available AACT database containing data on all trials registered at Clinical-Trials.gov since 2008 was used. The analysis was completed during three time periods from 2008-2019 of 4 years each. Results and conclusion Recruitment duration for industry-sponsored phase III clinical trials have increased significantly during the last 12 years from an average recruitment period of 13 months (IQR 7-23) in 2008-2011 to 18 months (IQR 11-28) in 2016-2019 (p = 0.0068). Further, phase III clinical trials have increased the number of registered sites per clinical trial by more than 30% during the last 12 years from a median number 43 sites (IQR 17-84) in 2012-2015 to 64 sites (IQR 30-118) in 2016-2019 (p = 0.025), and concurrently, the number of participants enrolled in clinical research has decreased significantly from 2012-2015 and 2016-2019 (p = 0.046). We believe that these findings indicate that recruitment for phase III clinical trials is less effective today compared to 12 years ago.

AB - Background Increasing costs and complexity in clinical trials requires recruitment of more narrowly defined patient populations. However, recruitment for clinical trials remains a considerable challenge. Aim Our overall aim was to quantify recruitment performance in industry-sponsored phase III clinical trials conducted globally during 2008-2019 with primary aim to examine development of overall clinical trial measures (number of trials completed, number of participants enrolled, trial duration in months) and key recruitment metrics (recruitment rate, number of sites, number of patients enrolled per site). Methods The publicly available AACT database containing data on all trials registered at Clinical-Trials.gov since 2008 was used. The analysis was completed during three time periods from 2008-2019 of 4 years each. Results and conclusion Recruitment duration for industry-sponsored phase III clinical trials have increased significantly during the last 12 years from an average recruitment period of 13 months (IQR 7-23) in 2008-2011 to 18 months (IQR 11-28) in 2016-2019 (p = 0.0068). Further, phase III clinical trials have increased the number of registered sites per clinical trial by more than 30% during the last 12 years from a median number 43 sites (IQR 17-84) in 2012-2015 to 64 sites (IQR 30-118) in 2016-2019 (p = 0.025), and concurrently, the number of participants enrolled in clinical research has decreased significantly from 2012-2015 and 2016-2019 (p = 0.046). We believe that these findings indicate that recruitment for phase III clinical trials is less effective today compared to 12 years ago.

UR - http://www.scopus.com/inward/record.url?scp=85135089670&partnerID=8YFLogxK

U2 - 10.1371/journal.pone.0271819

DO - 10.1371/journal.pone.0271819

M3 - Journal article

C2 - 35881593

AN - SCOPUS:85135089670

VL - 17

SP - 1

EP - 15

JO - PLoS ONE

JF - PLoS ONE

SN - 1932-6203

IS - 7 July

M1 - e0271819

ER -

ID: 316420086