Assessing the impact of COVID-19 on psychiatric clinical trials

Abstract

ObjectiveCOVID-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. MethodsWe 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. ResultsClinical 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. ConclusionCOVID-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.