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Assessing the impact of COVID-19 on psychiatric clinical trials

OBJECTIVE: COVID-19 and associated measures to control the spread of the COVID-19 has significantly impacted clinical research. This study aimed to determine the impact COVID-19 has had on psychiatric clinical trials and to assess whether certain trial areas or trial types were differentially affect...

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Autores principales: Cannon, Julie A., Strathman, Annabella R., Warner, Seth, Flignor, Jacob, Beck, Nataly S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Published by Elsevier Ltd. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8760184/
https://www.ncbi.nlm.nih.gov/pubmed/35123324
http://dx.doi.org/10.1016/j.jpsychires.2022.01.017
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author Cannon, Julie A.
Strathman, Annabella R.
Warner, Seth
Flignor, Jacob
Beck, Nataly S.
author_facet Cannon, Julie A.
Strathman, Annabella R.
Warner, Seth
Flignor, Jacob
Beck, Nataly S.
author_sort Cannon, Julie A.
collection PubMed
description OBJECTIVE: COVID-19 and associated measures to control the spread of the COVID-19 has significantly impacted clinical research. This study aimed to determine the impact COVID-19 has had on psychiatric clinical trials and to assess whether certain trial areas or trial types were differentially affected. METHODS: We used information from ClinicalTrials.gov, the largest online database of clinical trial information, to examine changes in psychiatric clinical trials from January 2010–December 2020. RESULTS: Clinical trial initiation decreased in 2020, with a year-on-year percent change in trial initiation of −5.4% versus an expected percent change based on forecasting observed trends from 2010 to 2019 of 8.6%. When broken down by disease area, the distribution of trials observed in 2020 was significantly different from the predicted distribution (p < 0.00001). The greatest decrease in trial initiation was seen in Schizophrenia-specific trials, with an observed percent change of −29.2% versus an expected percent change of 3.2%. Conversely, anxiety trials saw a significant increase in trial initiation during 2020, with an observed percent change of 24.6% versus an expected percent change of 16.0%. When assessing interventional versus observational studies, data showed a significant increase in initiation of observational psychiatric clinical trials (p < 0.05), and a significant decrease in initiation of interventional psychiatric clinical trials (p < 0.01). When data was analyzed on a month-by-month time scale, 7/12 months in 2020 showed significant decreases when compared to initiation during matching months over prior years, and a single month, June, showed a significant increase. CONCLUSION: COVID-19 has had significant impacts on the initiation of psychiatric clinical trials over 2020, and this decrease in trial initiation may have long-term impacts on the development and assessment of psychiatric treatments and therapeutics.
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spelling pubmed-87601842022-01-18 Assessing the impact of COVID-19 on psychiatric clinical trials Cannon, Julie A. Strathman, Annabella R. Warner, Seth Flignor, Jacob Beck, Nataly S. J Psychiatr Res Article OBJECTIVE: COVID-19 and associated measures to control the spread of the COVID-19 has significantly impacted clinical research. This study aimed to determine the impact COVID-19 has had on psychiatric clinical trials and to assess whether certain trial areas or trial types were differentially affected. METHODS: We used information from ClinicalTrials.gov, the largest online database of clinical trial information, to examine changes in psychiatric clinical trials from January 2010–December 2020. RESULTS: Clinical trial initiation decreased in 2020, with a year-on-year percent change in trial initiation of −5.4% versus an expected percent change based on forecasting observed trends from 2010 to 2019 of 8.6%. When broken down by disease area, the distribution of trials observed in 2020 was significantly different from the predicted distribution (p < 0.00001). The greatest decrease in trial initiation was seen in Schizophrenia-specific trials, with an observed percent change of −29.2% versus an expected percent change of 3.2%. Conversely, anxiety trials saw a significant increase in trial initiation during 2020, with an observed percent change of 24.6% versus an expected percent change of 16.0%. When assessing interventional versus observational studies, data showed a significant increase in initiation of observational psychiatric clinical trials (p < 0.05), and a significant decrease in initiation of interventional psychiatric clinical trials (p < 0.01). When data was analyzed on a month-by-month time scale, 7/12 months in 2020 showed significant decreases when compared to initiation during matching months over prior years, and a single month, June, showed a significant increase. CONCLUSION: COVID-19 has had significant impacts on the initiation of psychiatric clinical trials over 2020, and this decrease in trial initiation may have long-term impacts on the development and assessment of psychiatric treatments and therapeutics. Published by Elsevier Ltd. 2022-04 2022-01-15 /pmc/articles/PMC8760184/ /pubmed/35123324 http://dx.doi.org/10.1016/j.jpsychires.2022.01.017 Text en © 2022 Published by Elsevier Ltd. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Cannon, Julie A.
Strathman, Annabella R.
Warner, Seth
Flignor, Jacob
Beck, Nataly S.
Assessing the impact of COVID-19 on psychiatric clinical trials
title Assessing the impact of COVID-19 on psychiatric clinical trials
title_full Assessing the impact of COVID-19 on psychiatric clinical trials
title_fullStr Assessing the impact of COVID-19 on psychiatric clinical trials
title_full_unstemmed Assessing the impact of COVID-19 on psychiatric clinical trials
title_short Assessing the impact of COVID-19 on psychiatric clinical trials
title_sort assessing the impact of covid-19 on psychiatric clinical trials
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8760184/
https://www.ncbi.nlm.nih.gov/pubmed/35123324
http://dx.doi.org/10.1016/j.jpsychires.2022.01.017
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