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Analysis from Phesi shows the impact of COVID-19 on clinical development is continuing to mount, with many clinical trial sites unable to bounce back following suspension in March and April 2020. Phesi’s previous analysis in May 2020 found that, of 300,000 global clinical trial sites, there had been a 38% increase in suspensions from the beginning of the year. Now, new analysis from September 2020 indicates these suspensions peaked in early June, and after an initial drop, have risen again—with over 28,000 sites currently suspended.
Sites did begin recruiting again in June 2020, rising to almost pre-pandemic levels. But the analysis shows that while new sites have appeared, many other investigator sites could go under forever. The sudden increase in recruiting sites is likely due to sponsors scrambling to mitigate the impact of COVID-19 and blindly adding new sites, without analyzing via systematical root cause analysis how well their trials were doing in the first place before the pandemic struck. One important note is that this initial analysis can’t show all the variables, because many sponsors and CROs are yet to release COVID-19 data.
“Even in ‘normal’ times, adding new sites to an ongoing recruiting trial, as is happening here, is a very risky practice without analyzing the true impact of such a move,” commented Dr. Gen Li, President, Phesi. “In many suspended trials, COVID-19 is likely to only have been a superficial trigger for a much deeper problem in the design and enrollment, given around a fifth of trials fail in ordinary circumstances. Adding an extra site can actually just exacerbate existing problems when decisions are not data-led, rather than solving them. Biopharmaceutical organizations planning budgets for 2021 need to take a data-driven view in order to make accurate clinical development decisions that will help them navigate the difficult conditions the sector is facing.”
Phesi’s further analysis of data on clinical trial enrollment closure shows that COVID-19 is also having significant impact on Phase II and III trials.
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