Social distancing and locking may have reduced the spread of COVID-19, but researchers at Penn State College of Medicine also report that these actions may have affected the ability of clinical researchers to complete trials. Completion rates fell worldwide between 13% and 23%, depending on the type of research sponsor and geographical location, between April and October 2020.
Researchers previously reported that more than 80% of clinical trials suspended between March 1 and April 26, 2020, indicated that a pandemic was their main reason for stopping activity. Patient enrollment in studies was lower in April 2020 compared to April 2019. Arthur Berg, associate professor of public health sciences, and Nour Hawila, PhD in biostatistics, explored how these trends could affect the completion of clinical trials.
Researchers examined more than 117,000 trials in the United States, Europe, Asia and other regions to examine whether the pandemic affected clinical research. Their goal was to assess how pandemic mitigation efforts and financial delays could have contributed to reduced enrollment and completion of clinical trials.
The pandemic has made it difficult for researchers to recruit and monitor patients in clinical trials. This analysis revealed that the impact was significant -; especially for trials funded by government, academia, or medical personnel. “
Nour Hawila, Research Associate, Department of Public Health Sciences
Hawila and Berg analyzed data from ClinicalTrials.gov, a website that contains information on the status of thousands of clinical trials in U.S. Pre-COVID-19 enrollment and completion data collected from March 2017 to February 2020. Post-COVID-19 the period is defined from April to October 2020.
According to the researchers, the pandemic has reduced the number of new clinical trial intervention submissions on ClinicalTrials.gov by about 10%. Completed trials fell 13% to 23%, depending on the sector and location of the test source. Clinical trials sponsored by pharmaceutical, biotech and therapeutic companies are more likely to complete enrollment.
However, some regions fared better than others during the pandemic. Egypt recorded an increase in both reported (69%) and completed (73%) clinical trials. Berg explained that the increase is probably a response to the recent parliamentary law on medical research in the country.
Berg and Hawila also noted that the pandemic caused a change in research priorities -; 472 (11%) trials submitted during the post-COVID period were associated with a pandemic. The results were published in the journal Clinical and translational science.
“The response of clinical research to the pandemic has been strong,” said Berg, a researcher at the Penn State Cancer Institute and director of the doctoral program in biostatistics. “But the impact of the pandemic on other types of clinical trials will be felt in the coming decades. However, as shown in Egypt, timely government measures may change the changing impact of the pandemic on research.”
Penn State College of Medicine
Hawila, N & Berg, A (2021) Assessment of the impact of COVID-19 on registered interventional clinical trials. Clinical and translational science. doi.org/10.1111/cts.13034.