Pandemic mitigation efforts may have contributed to lower clinical trial completion rates

Social distancing and lockdowns 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. Graduation rates globally fell between 13% and 23%, depending on the type of research sponsor and geographic location, between April and October 2020.

Researchers previously reported that more than 80% of clinical trials suspended between March 1 and April 26, 2020, noted the pandemic as the main reason for the shutdown. Patient enrollment into studies was lower in April 2020 compared to April 2019. Arthur Berg, associate professor of public health sciences, and Nour Hawila, doctoral student in biostatistics, investigated how these trends may have affected completion of studies. clinical tests.

Researchers looked at more than 117,000 trials in the United States, Europe, Asia and other regions to determine whether the pandemic had affected clinical research. Their goal was to assess how pandemic mitigation efforts and financial setbacks may have contributed to the decline in clinical trial participants and their completion.

The pandemic has made it more difficult for researchers to recruit and follow patients in clinical trials. This analysis revealed that the impact was substantial -; especially for trials funded by government, academic or medical entities. “

Nour Hawila, research assistant, 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 the United States Pre-COVID-19 enrollment and completion data has been extracted from March 2017 to February 2020. The post-COVID-19 period has been defined from April to October 2020.

According to the researchers, the pandemic has reduced the number of new interventional clinical trial submissions to ClinicalTrials.gov by about 10%. Completed trials were down from 13% to 23%, depending on the industry and the location of the test source. Clinical trials sponsored by pharmaceutical, biotechnology and therapeutics companies were more likely to complete recruitment.

However, some regions resisted better than others during the pandemic. Egypt has seen an increase in clinical trials submitted (69%) and completed (73%). Berg explained that the increase is likely in response to the country’s recent parliamentary bill governing medical research.

Berg and Hawila also noted that the pandemic had caused a shift in research priorities -; 472 (11%) of trials submitted during the post-COVID period were linked to a pandemic. The results were published in the journal Clinical and translational science.

“The response of clinical research to the pandemic has been robust,” 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 for decades to come. However, as demonstrated in Egypt, timely government action could make a difference in reversing the impact of the pandemic on research. “