The COVID-19 pandemic significantly disrupted ongoing clinical trials in various stages, with more than 1,000 trials by sponsors, collaborators, or contract research organisations having gone off the trial schedules.
Although early disruptions are now slowing down, regulatory approvals are expected to be delayed.
Verdict has conducted a poll to assess how long it would take for clinical trials disrupted by COVID-19 to return to normal.
Analysis of the results shows that a year or more may pass for the disrupted trials to return to normal.
A majority 27% of the respondents opined that the disrupted clinical trials could take more than 12 months to return to normal, while 23% felt that four to six months may be enough and 22% were optimistic about witnessing normalcy in just three months.
Further, 15% of the respondents felt that it could take seven to nine months for disrupted clinical trials to return to normal followed by 13% who felt that it could take ten to 12 months.
The analysis is based on 731 responses received from readers of Clinical Trials Arena, a Verdict network site, between 08 July and 03 August.
COVID-19 impact on pharmaceutical clinical trials
The COVID-19 pandemic has disrupted various aspects of clinical trials including enrolment, supply chains, and trial initiation, according to GlobalData. Further, lockdown restrictions forced sponsors to implement stricter measures to ensure patient safety.
Phase two clinical trials were the most disrupted at 43%-45%, followed by Phase three trials at 22%-25%, and Phase one trials at 21%-26%, according to GlobalData. Majority of the trials impacted were in oncology, followed by central nervous system (CNS) and infectious diseases.
The disruption caused by the coronavirus pandemic began to decline since June as lockdown measures were gradually eased.
Regulatory agencies such as the US Food and Drug Administration (FDA) have issued guidelines on how clinical trials should be conducted during the pandemic. The FDA has recommended methods such as virtual visits, phone interviews, and self-administration to ensure the continuation of the trials.