Quantifying the impact of the COVID-19 pandemic on clinical trial screening rates over time in 37 countries.

COVID-19 Clinical trials Coronavirus Enrollment Global Impact Pandemic Recruitment SARS-CoV-2 Screening

Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
04 Apr 2023
Historique:
received: 20 10 2022
accepted: 24 03 2023
medline: 5 4 2023
entrez: 4 4 2023
pubmed: 5 4 2023
Statut: epublish

Résumé

The COVID-19 pandemic has had an unprecedented and disruptive impact on people's health and lives worldwide. In addition to burdening people's health in the short-term in the form of infection, illness, and mortality, there has been an enormous negative impact on clinical research. Clinical trials experienced challenges in ensuring patient safety and enrolling new patients throughout the pandemic. Here, we investigate and quantify the negative impact that the COVID-19 pandemic has industry-sponsored clinical trials, both in the USA and worldwide. We find a negative correlation between the severity of the COVID-19 pandemic and clinical trial screening rate, with the relationship being strongest during the first three months of the pandemic compared to the entire duration of the pandemic. This negative statistical relationship holds across therapeutic areas, across states in the USA despite the heterogeneity of responses at the state-level, and across countries. This work has significant implications for the management of clinical trials worldwide in response to the fluctuating severity of COVID-19 moving forward and for future pandemics.

Identifiants

pubmed: 37013558
doi: 10.1186/s13063-023-07277-1
pii: 10.1186/s13063-023-07277-1
pmc: PMC10071259
doi:

Types de publication

Letter

Langues

eng

Sous-ensembles de citation

IM

Pagination

254

Informations de copyright

© 2023. The Author(s).

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Auteurs

Kelsey McDonald (K)

Labcorp Drug Development Inc, 206 Carnegie Center Dr, Princeton, NJ, 08540, USA.

Earl Seltzer (E)

Labcorp Drug Development Inc, 206 Carnegie Center Dr, Princeton, NJ, 08540, USA.

Mary Lu (M)

Labcorp Drug Development Inc, 206 Carnegie Center Dr, Princeton, NJ, 08540, USA.

Stefan Diaz Gaisenband (SD)

Labcorp Drug Development Inc, 206 Carnegie Center Dr, Princeton, NJ, 08540, USA.

Cassandra Fletcher (C)

Labcorp Drug Development Inc, 206 Carnegie Center Dr, Princeton, NJ, 08540, USA.

Patrick McLeroth (P)

Labcorp Drug Development Inc, 206 Carnegie Center Dr, Princeton, NJ, 08540, USA.

Kamal S Saini (KS)

Labcorp Drug Development Inc, 206 Carnegie Center Dr, Princeton, NJ, 08540, USA. Kamal.saini@nhs.net.
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK. Kamal.saini@nhs.net.

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Classifications MeSH