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Wednesday, June 8, 2022

COVID and Clinical Trials

In The Politics of Autism, I discuss the day-to-day challenges facing autistic people and their families. Those challenges get far more intense during disasters.  And coronavirus is proving to be the biggest disaster of all. 

At Autism Research, Monika Neale and colleagues have a short report titled "The impact of COVID-19 on autism research: A cross-sectional analysis of discontinued or suspended clinical trials."
The overall discontinuation rate of registered autism trials between January 1, 2020 and July 31, 2021 was 7.6%, impacting 735 participants, which is a lower overall rate compared to other areas of clinical research (Desai et al., 2021). Nearly half of the autism trials that were discontinued explicitly cited COVID-19 as the primary reason for discontinuation.

Overall, 368 participants were enrolled in the trials impacted by COVID-19. Over 200 of these participants were children between the ages of 2–8 years old. Given the increasing number of children hospitalized with COVID-19 between May 2020 and May 2021 (Delahoy et al., 2021), the decision to halt autism trials involving children was likely necessary when switching to tele-consultation or other non-face-to-face methodology would compromise the integrity of the trial.

Drug trials were the most vulnerable to terminations and suspensions during COVID-19 with a discontinuation rate of 20%, impacting 574 participants, which indicates a sixfold likelihood of discontinuation when compared to non-pharmacological interventions. Half of the discontinued drug trials cited COVID-19 as the reason for discontinuation, likely reflecting interruptions in drug and medical supplies (Asaad et al., 2020). Two more studies indicated recruitment issues, which may be attributable to the pandemic and changes in FDA guidelines.

Diagnostic testing, behavioral approaches, and parent-mediated interventions appeared to be flexible study designs with discontinuation rates of under 4% affecting a total of 102 participants. These trials may have had an online component or were easily converted to telehealth, as suggested by the FDA (U.S. Department of Health and Human Services, Food and Drug Administration, 2020). Lindgren et al. (2016), showed similar efficacy between telehealth and traditional clinic-based Applied Behavior Analysis (ABA) treatment for autism, which further supports a decision to adapt protocols to online participation without compromising internal validity while incorporating an extra safety measure.

Of the 11 trials investigating “physical activity” to manage symptoms of autism, only one trial was discontinued, and it was due to funding. This is a noteworthy finding indicating that demonstrations accompanying physical activity interventions could also easily be adapted to a web-based experience, as described in the PLANE project by Ketcheson and Pitchford (2021). Although the full effect of telehealth physical activity interventions is not widely studied, a systematic review by Seron et al. (2021) demonstrated its efficacy.

None of the eight “dietary or supplements” trials were discontinued. This is most likely attributable to the fact that dietary interventions tend to be home-based and therefore sheltered from the risks associated with office visits. Further, dietary supplements are not regulated by the FDA (Center for Food Safety & Applied Nutrition, 2020), which may have allowed for additional flexibility.

One of the short-term implications of clinical trial discontinuation is that individuals whose only access to treatment was through participation in these trials missed an opportunity for services. Long term, however, having to adjust study designs due to the pandemic allows researchers to evaluate the adaptability of their methods. Given the overall successful continuation of the majority of clinical trials of autism research, methods from these clinical trials should be assessed for adaptability in other fields of medicine and behavioral therapies where applicable.