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

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

 


Social distance and blockade may have reduced the spread of COVID-19, but researchers at Pennsylvania State Medical College also said that these behaviors could have affected clinical researchers’ ability to complete trials. I am reporting. Study completion rates declined between 13% and 23% worldwide between April and October 2020, depending on the type of research sponsor and geographic location.

Researchers previously reported that more than 80% of clinical trials suspended between March 1st and April 26th, 2020 said that pandemics were the main reason for their inactivity. Patient enrollment in the April 2020 study was lower than in April 2019. Arthur Berg, an associate professor of public health science, and Nour Hawila, a PhD candidate in biostatistics, investigated how these trends affected the completion of clinical trials.

Researchers have investigated more than 117,000 trials in the United States, Europe, Asia, and elsewhere to study whether pandemics have affected clinical research. Their goal was to assess how pandemic mitigation efforts and economic recessions contributed to reduced enrollment and completion of clinical trials.

The pandemic has made it more difficult for researchers to recruit and follow up with patients in clinical trials. This analysis revealed significant impact-; especially for trials funded by governments, academic institutions, or healthcare organizations. “

Nour Hawila, Research Assistant, Faculty of Public Health Sciences

Hawila and Berg analyzed data from ClinicalTrials.gov. It was acquired from March 2017 to February 2020 on a website that contains information on the status of thousands of clinical trials in US COVID-19 pre-registration and completion data. The post-COVID-19 period was defined as April-October 2020.

According to researchers, the pandemic reduced the number of new intervention clinical trials submitted to ClinicalTrials.gov by about 10%. Completed trials decreased by 13% to 23%, depending on the sector and location of the trial’s source. Clinical trials sponsored by pharmaceutical, biotechnology and treatment companies were likely to complete registration.

However, during the pandemic, some areas performed better than others. In Egypt, there was an increase in both submitted (69%) and completed (73%) clinical trials. Berg explained that the rise is likely to correspond to a recent parliamentary bill in the country governing medical research.

Berg and Howila also stated that the pandemic caused a change in study priorities-; 472 (11%) of trials submitted during the post-COVID period were pandemic-related.The result was published in the journal Clinical and translation science..

“The response of clinical research to pandemics was strong,” said Berg, a researcher at the Penn State Cancer Institute and director of the PhD in Biostatistics. “But the impact of pandemics on other types of clinical trials will be felt over the next few decades, but timely government action, as demonstrated in Egypt, has led to pandemic research. It can make a difference in reversing the impact. “

Source:

Journal reference:

Hawila, N & Berg, A (2021) Assessment of the impact of COVID-19 on enrolled intervention clinical trials. Clinical and translation science. doi.org/10.1111/cts.13034..

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