Clinical Trials Are Starting Back Up, but Some Future Approvals May be Delayed

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As the COVID-19 pandemic ramped up in March, April and May around the globe, numerous clinical trials for other diseases were paused in order to free up clinics and hospitals as well as to decrease the risk to patients. If companies were able to do so or the disease being studied was critical, trials continued or changes were made to improve access, such as televisits and other approaches.

According to a BioPharma Dive report, since March, more than 100 biopharma companies announced their clinical trials were disrupted in some way because of the pandemic.

Today, the European Pharmaceutical Review reported a GlobalData study that found more than 200 clinical trials that had been disrupted are now ongoing or completed. This is a 3.2-times increase compared to May.

“The number of disrupted clinical trials and organizations has continued to grow over the last three months,” said Brooke Wilson, associate director of Trials Intelligence at GlobalData. “This trend is most noticeable between April and May but has begun to slow. Suspension of enrollment accounted for 61.5% of the disruptions. Over all three months, 14% of the disrupted clinical trials are specifically pivotal/registrational, giving an indication that there will be an impact on regulatory approvals in the future.”

It's difficult to say how the disruptions will ultimately impact drug approvals. A CNBC report suggests that for the U.S. Food and Drug Administration (FDA), the near-term impact could mean a backlog once biopharma companies finish their trials and submit their New Drug Applications (NDAs), according to analysts.

“You might see a burst of activity start to hit the regulatory authorities,” said former FDA Commissioner Scott Gottlieb, who is now a board member of Pfizer, Tempus and Illumina. “The agency has been keeping up,” so far, he added.

The last set of delays for the agency was during the partial government shutdown in early 2019. The shutdown was related to a battle over President Donald Trump’s demand for a border wall between U.S. and Mexico. The FDA continued many operations but furloughed about half its workforce and stopped accepting NDAs or fees.

Gottlieb, who ran the agency at that time, said, “We were able to keep up with it, but [the shutdown] was only a month, month and a half.”

During the pandemic, the agency has appeared to keep up quite well with approvals overall while shifting many of its resources toward COVID-19.

“With many staff members working on COVID-19 activities, it is possible that we will not be able to sustain our current performance level in meeting goal dates indefinitely,” the FDA wrote in a May 26 document.

In response, FDA created a website specifically to assist biopharma companies with clinical trials. CNBC questioned the agency about a potential bottleneck and the FDA said it continues to “perform our medical product review activities as well as contribute to other vital functions of the agency.”

An FDA spokesperson added, “We are working around the clock to monitor and mitigate emerging coronavirus-related issues with our federal partners, international regulators, and medical product developers and manufacturers to advance response efforts to combat the coronavirus disease (COVID-19) outbreak. Our application review teams remain focused on their work, and we are doing everything possible to maintain continuity of operations in a very dynamic situation and will continue to be flexible and as transparent as possible.”

Some experts believe that specific areas, such as cancer and rare diseases, which are a high priority for the FDA, will likely remain on track. Other areas, such as generic drugs, and possibly medical devices, may be slower.

“There’s definitely some lingering concerns about FDA reviews taking a little bit longer,” said Mike Bailey, director of research at FBB Capital Partners and a former healthcare analyst at Stifel. “Especially for medical devices. … That is a whole another layer because of the COVID delays.”

Brian Skorney, an analyst at Robert W. Baird & Co. expects delays down the road “as we see a need for the FDA to evaluate clinical trial data in a background where participants may be dropping out of studies or a much larger number of data points in a study will be missing.”

But Skorney doesn’t think major drug advances will be delayed, although there is a possibility in the U.S. we “could see a slowdown in approvals for marginally effective drugs because of prioritization. How much of a headwind this becomes for the industry will probably be determined by how COVID spread occurs over the next few months. A major spike would slow things down more and a successful reopening without a major rebound in cases would probably see a very limited impact on regulatory approvals.”

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