Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2021 Jan 1;18(1-3):35-38.
eCollection 2021 Jan-Mar.

Drug Development for Mental Illness: How Psychiatry Clinical Trial Sites are Meeting the Challenge of the COVID-19 Pandemic

Affiliations
Editorial

Drug Development for Mental Illness: How Psychiatry Clinical Trial Sites are Meeting the Challenge of the COVID-19 Pandemic

Robert E Litman et al. Innov Clin Neurosci. .

Abstract

Objective: The goal was to review the impact of the COVID-19 pandemic on psychiatric drug development and clinical trials. Main Points of Discussion: Disruption of pharmaceutical industry- sponsored clinical trials for psychiatric disorders by the COVID-19 pandemic, prompted by concerns regarding the safety of trial participants and the feasibility of trial conduct, has adversely impacted psychiatric drug development. In response, psychiatry trial sites have modified clinical trials and adapted trial conduct, through the use of social distancing, personal protective equipment, laboratory testing, and remote assessments, to reduce the risks of COVID-19. We review the implications of these modifications for participant safety, safe trial conduct, and data integrity. Conclusion: Given these implications, ongoing communication and consultation are needed between trials sites, sponsors, and all other stakeholders to ensure continued progress in psychiatric drug development during the pandemic.

Keywords: COVID-19; Clinical trials; psychiatry.

PubMed Disclaimer

Conflict of interest statement

FUNDING:No funding was provided for this study. DISCLOSURES:Dr. Litman is a member of the Speaker's Bureau for Janssen, AbbVie, and Allergan Pharmaceuticals. The other authors have no conflicts of interest relevant to the content of this article.

References

    1. Tolaney SM, Lydon CA, Li T The impact of COVID-19 on clinical trial execution at the Dana-Farber Cancer Institute. J Natl Cancer Inst. 2020. - PMC - PubMed
    1. Anker SD, Butler J, Khan MS et al. Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an expert consensus position paper from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC). Eur Heart J. 2020;41(22):2109–2117. - PMC - PubMed
    1. GlobalData HealthCare. Impact of Covid-19 pandemic on clinical trials evaluating various neurology indications website. https://www.clinicaltrialsarena.com/comment/ neurology-clinical-trials-c... 17 Apr 2020. Accessed 30 Jul 2020.
    1. GlobalData HealthCare. Update on clinical trials disrupted due to Covid-19 website. https://www.clinicaltrialsarena.com/comment/disrupted-clinical-trials-co... 14 May 2020. Accessed 30 Jul 2020.
    1. Druss BG. Addressing the COVID-19 pandemic in populations with serious mental illness [editorial]. 2020. JAMA Psychiatry. - PubMed

Publication types

LinkOut - more resources