The impact of COVID‐19 on autism research: A cross‐sectional analysis of discontinued or suspended clinical trials

Abstract

Due to uncertainties associated with the COVID-19 public health crisis, several clinical trials had to be withdrawn or postponed. Our investigation aimed to assess the rate of discontinuation of clinical trials focusing on Autism Spectrum Disorder. Of the 197 registered trials included in our systematic review, 15 (7.6%) were discontinued, with nearly half of these explicitly citing COVID-19 as their reason for discontinuation. Pharmacological trials were six times more likely to be discontinued during the pandemic than non-pharmacological studies. The difference between the likelihood of discontinuation was statistically significant (OR: 6.13; 95% CI: 1.22-30.71). There was no evidence of association between funding source and reasons for discontinuation. Limitations, along with implications for future trials are discussed. Lay SummaryWe investigated the impact of the COVID-19 pandemic on the discontinuation rate of autism clinical trials. We found that drug trials were six times more likely to be discontinued during the pandemic compared to behavioral, diagnostic, and nutritional trials. The overall discontinuation rate was notably lower in autism clinical trials than in other areas of medical research. We recommend an examination of the methodology of the continued autism trials to assess their applicability in other fields.

The impact of the COVID-19 pandemic on early termination of ophthalmology clinical trials: A cross-sectional analysis of ClinicalTrials.gov

“…Our study adds to the growing literature assessing the impact of COVID-19 on clinical trials registered on ClinicalTrials.gov. 17 – 19 , 23 We found 34 (34/2280, 1.49%) OCT discontinuations due to the pandemic. Our results are similar to other fields such as autism (15/197, 7.6%), otolaryngology (33/1777, 1.9%), anesthesia (24/823, 2.9%), and depressive disorders (5/56, 8.9%).…”

“…On June 10, 2022, ClinicalTrials.gov was accessed through the Aggregate Content of ClinicalTrials.gov (AACT), a comprehensive, relational database of ClinicalTrials.gov that is updated daily. 16 We searched the AACT using terms listed on the “Eye Diseases” page of ClinicalTrials.gov and downloaded a dataset containing every registered OCT. As performed by similar studies, 17 – 19 we used the “last update posted date” as a proxy to identify trials possibly affected by COVID-19 and to track changes in trial recruitment status. We included trials last updated between January 1, 2020 and June 8, 2022, the latest version of the database.…”

“…Trials with multiple sponsors were characterized by the lead sponsor. Similar to other studies, [17][18][19] we coded trials as U.S. studies if any trial facility was in the United States and non-U.S. studies if all facilities were outside the United States. Furthermore, early phase I trials were categorized as phase I, phase I-II trials were categorized as phase II, and phase II-III trials were categorized as phase III.…”

The impact of COVID-19 on psychiatry research: A cross-sectional analysis of discontinued clinical trials for depressive disorders

“…The pandemic's impact on psychiatric research is likely to have long-lasting effects ( Türközer and Öngür, 2020 ). The effect of the pandemic on Autism Spectrum Disorder clinical research has been described ( Neale et al., 2022 ), but it has yet to be described for the depressive disorders. Thus, the impact of the pandemic on registered clinical trials investigating depressive disorder interventions may be significant and warrants investigation.…”

“…The COVID-19 pandemic and recruitment difficulties were equally likely to be reported as a reason for discontinuation, together accounting for over a third of trial discontinuations during the pandemic. The pandemic revealed the vulnerability of psychiatric clinical trials regarding recruitment and the need to adapt trial design for future psychiatric trials ( Neale et al., 2022 ; Perlis, 2020 ). We recommend that the use of telemedicine for monitoring and treatment of depressive disorders continue to be used and explored, as this will likely limit the impact of future pandemics on clinical research.…”