Cavazzoni: Pandemic-era tools, learnings are here to stay

Regulatory NewsRegulatory News | 07 June 2022 |  By 

FDA's Patrizia Cavazzoni

The US Food and Drug Administration’s (FDA) top drug official said the pandemic has prompted the agency to consider new ways of working going forward and has renewed calls for industry to embrace digital technologies and decentralized models for conducting clinical trials. The pandemic has also prompted the agency to re-evaluate its hiring practices, and to adopt the use of alternative tools in lieu of onsite inspections, which have become a permanent fixture in the agency’s “toolbelt.”
So asserted Patrizia Cavazzoni, director of FDA’s Center for Drugs Evaluation and Research (CDER) who discussed how some of the agency’s learnings during the pandemic will be applied going forward at the agency’s annual Regulatory Education for Industry conference on Monday.
“We have really seen an expansion of the utilization of [digital health] technologies as an essential tool to allow for greater use of decentralized clinical trials which are very important during the pandemic,” Cavazzoni said.
She added that the decentralized model is vital for being able to continue enrolling and evaluating patients remotely without subjects “having to go to investigative sites during lockdowns.”
FDA published a draft guideline for sponsors on the use of digital technologies to aid in remote clinical data collection. (RELATED: Digital health tech in clinical investigations: FDA issues draft guidance, Regulatory Focus 5 January 2022)
Cavazzoni said that FDA is committed to promoting greater use of decentralized clinical trials. “We really have to expand the utilization of these decentralized clinical trials,” she said, adding that such trials “have some very distinct advantages that will serve us well in a post-pandemic world. For instance, they allow us to reach populations that would not necessarily have access to clinical trials.”
She noted that studies have shown that “as low as only 1% of eligible patients actually participate in clinical trials. One of the reasons for that is – it can be very cumbersome to be in clinical trials, to have to travel to investigator sites for evaluations, for lab work.”
Cavazzoni added that decentralized trials “have really helped us during the pandemic and they are here to stay in a post-pandemic world.”
FDA is currently developing a guidance that will “entrench the utilization of decentralized clinical trials going forward,” which should be available shortly, she said.
Cavazzoni noted that some of the principles in the upcoming guidance will draw from FDA’s previous guidance issued in 2020 addressing trials impacted by COVID-19. (Related: FDA Unveils Guidance for Trials Impacted by COVID 19, Regulatory Focus 18 March 2020)
Top officials at FDA have been calling for more flexibility in how clinical trials are designed to accommodate more patients and have extolled the benefits of master protocols as one way to increase enrollment in the post COVID-19 world. (REATED: DIA: Woodcock, other top officials tout benefits of master protocols, want momentun to continue post-COVID, Regulatory Focus 2 July 2021)
Another lesson learned is that the agency will continue using alternative tools, such as desktop assessment and virtual assessments.
She said that while these tools “are not fit for purpose for every single situation, there will always be some instances where we have no choice but to do an on-site inspection, and examples of those instances are in facilities – be that manufacturing or investigative sites, etc. –that are completely new to us, for instance, that have no inspection history, or facilities that have a poor track record when it comes to quality and compliance.”
“However, we do see these alternative approaches to inspection, which entail document review, sometimes remote camera assessment, and so on, to be part of our toolbelt in the post-pandemic world, and we think that it will allow us to be more agile and flexible in certain situations,” Cavazzoni added.
Another learning is the agency has taken a different direction when it comes to attracting and retaining new talent. As part of this effort, FDA is now allowing new staff to work remotely.
Cavazzoni said “we a very conscious of the fact that we have a lot of competition from the world out there, including the private sector” which offers “greater flexibility” when it comes to working remotely.
“We know that it is increasingly possible to change jobs without necessarily having to move and having the kids change schools. So we really want to create an environment at CDER, and at FDA, that has similar flexibilities as some of those that are offered by private employers, including a workplace flexibility options as well as continuing opportunity for career development and advancement.”
She said the agency received additional funding thought the 21st Century Cures Act, which allowed the hiring of additional staff “in a more streamlined fashion.” Such funding has ensured the agency remains competitive with the private sector.
Another priority going forward, said Cavazzoni, is to ensure that the products approved during the pandemic through an emergency use authorization (EUA) will remain available post-pandemic.
“Emergency use authorizations are a very important tool; however, they are very much tied to the public health emergency, and so we need to start thinking ahead on how these products will remain available after the public health emergency.”
The agency has been working with sponsors early on so that when they request EUAs, the “data that they provided us could serve ultimately as the foundation, maybe with additional data, to support an application for an NDA and BLA, so that these products could ultimately remain available following the public health emergency.”
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