Social distancing and lockdowns may have reduced the spread of COVID-19, but researchers from Penn State College of Medicine also report those actions may have affected clinical researchers’ ability to finish trials. Between April and October 2020, study completion rates dropped worldwide between 13% and 23%, depending on the type of research sponsor and geographic location.
Researchers previously reported that more than 80% of the clinical trials that were suspended between March 1 and April 26, 2020 noted the pandemic as their chief reason for halting activity. Patient enrollment in studies was lower in April 2020 compared to April 2019. Penn State’s Arthur Berg, associate professor of public health sciences, and Nour Hawila, a biostatistics doctoral candidate, investigated how these trends may have affected the completion of clinical trials.
The researchers examined more than 117,000 trials in the United States, Europe, Asia, and other regions. Their goal was to assess how the pandemic’s mitigation efforts and financial setbacks may have contributed to decreased clinical trial enrollment and completion.
“The pandemic has made it more difficult for researchers to recruit and follow up on patients in clinical trials,” said Hawila, a research assistant from the Department of Public Health Sciences. “This analysis revealed that the impact was substantial—particularly for trials funded by government, academic, or medical entities.”
Hawila and Berg analyzed data from ClinicalTrials.gov. Pre-COVID-19 enrollment and completion data were pulled from March 2017 to February 2020. The post-COVID-19 period was defined as April through October 2020.
According to researchers, the pandemic reduced the number of new interventional clinical trial submissions to ClinicalTrials.gov by about 10%. Completed trials were down 13% to 23%, depending on the sector and location of the trial source. Clinical trials sponsored by pharmaceutical, biotechnology, and therapeutic companies were more likely to complete enrollment.
Berg and Hawila also noted that the pandemic caused a shift in research priorities—472 (11%) of trials submitted during the post-COVID period were related to the pandemic. The results were published in the journal Clinical and Translational Science.
“Clinical research response to the pandemic has been robust,” said Berg. “But the impact of the pandemic on other types of clinical trials will be felt for decades to come. However…timely governmental action may be able to make a difference in reversing the pandemic’s impact on research.”
This work was supported by the National Institutes of Health and the National Center for Advancing Translational Science.
Edited by Gary Cramer