Robert E Litman1,2,3, Peter Sorantin1,2,3, Elia E Acevedo-Diaz1,2,3. 1. Drs. Litman is with CBH Health, Georgetown University Medical School in Washington, DC. 2. Dr. Sorantin is with Sorantin Outcomes, LLC, in Mountain Lakes, New Jersey. 3. Dr. Acevedo-Diaz is with CBH Health and the National Institute of Mental Health (NIMH) in Bethesda, Maryland.
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.
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.
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