Social distancing and bans may have reduced the spread of COVID-19, but researchers at Penn State College of Medicine also report that these measures may have adversely affected clinical researchers’ ability to complete studies. Between April and October 2020, study completion rates dropped between 13% and 23% globally, depending on the type of research sponsor and geographic location.
Researchers previously reported that more than 80% of clinical trials that were suspended between March 1 and April 26, 2020 cited the pandemic as the primary reason for halting activity. The number of patients participating in studies was lower in April 2020 than in April 2019. Arthur Berg of Penn State, Associate Professor of Public Health Sciences, and Nour Hawila, PhD student in Biostatistics, examined how these trends affect clinical graduation Studies could have had an impact.
The researchers examined more than 117,000 studies in the United States, Europe, Asia, and other regions. Their aim was to assess how the mitigation efforts and financial setbacks from the pandemic could have contributed to decreased registrations and the completion of clinical trials.
“The pandemic has made it difficult for researchers to enroll and monitor patients in clinical trials,” said Hawila, a research fellow with the Department of Public Health Sciences. “This analysis found that the impact was significant – especially in studies funded by government, academic, or medical institutions.”
Hawila and Berg analyzed data from ClinicalTrials.gov. Pre-COVID-19 registration and completion dates were accessed from March 2017 to February 2020. The period after COVID-19 was defined as April to October 2020.
According to researchers, the pandemic reduced the number of new interventional clinical trials at ClinicalTrials.gov by about 10%. Completed studies decreased by 13% to 23% depending on the sector and location of the study source. Clinical trials sponsored by pharmaceutical, biotechnology, and therapy companies were more likely to complete registration.
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Berg and Hawila also noted that the pandemic shifted research priorities – 472 (11%) of the studies submitted during the post-COVID period were related to the pandemic. The results were published in the journal Clinical and Translational Science.
“The clinical research response to the pandemic has been robust,” Berg said. “However, the effects of the pandemic on other types of clinical trials will be felt in the decades ahead. However … timely government action can potentially make a difference in reversing the impact of the pandemic on research. “
This work was supported by the National Institutes of Health and the National Center for Advancing Translational Science.
Edited by Gary Cramer