Researchers at Penn State College of Medicine found that social distancing and locking in response to Covid-19 were significant obstacles to the completion of clinical trials.
Researchers from Penn State report that worldwide completion rates fell by between 13% and 23%, depending on the nature of the research sponsor and geographic location, between April and October 2020.
Previous studies have shown a decline in the number of exams enrolled in April 2020 compared to April 2019, and that more than 80% of clinical trials suspended between March 1 and April 26, 2020 attributed the pandemic to the main reason for stopping activity.
Penn State researchers Arthur Berg and Nour Hawila analyzed how these trends could have influenced the completion of clinical trials.
Berg and Hawila examined over 117,000 trials in the United States, Europe, Asia, and elsewhere to estimate how pandemic mitigation efforts and economic downtime could have contributed to reduced enrollment and completion of clinical trials.
They researched data from ClinicalTrials.gov, which publishes information on the status of thousands of clinical trials in the U.S., and statistics on registration and completion before Covid-19 were extracted from March 2017 to February 2020. The period after Covid-19 was defined as April to October 2020.
“The pandemic has made it difficult for researchers to recruit and monitor patients in clinical trials,” Hawila said. “This analysis found that the effect was significant – especially for trials funded by government, academics or medical professionals.”
The study found that the pandemic reduced the number of new clinical trial intervention submissions on ClinicalTrials.gov by about 10%.
Significantly, clinical trials sponsored by pharmaceutical, biotech and therapeutic firms are more likely to complete enrollment.
Berg and Hawila also saw that the pandemic caused a shift in the focus of research during the post-Covid period, with 472 trials – 11% of the total – filed at the time regarding Covid.
Clinical research efforts in some countries intensified during the pandemic.
Egypt recorded an increase in both reported (69%) and completed (73%) clinical trials. Berg said the increase is likely due to the country’s recent parliamentary law governing medical research.
“The response of clinical research to the pandemic has been strong,” Berg said. “But the impact of the pandemic on other types of clinical trials will be felt in the coming decades. However, as demonstrated in Egypt, timely government action may be able to reverse the impact of the pandemic on research.