The U.S. Food and Drug Administration (FDA) is increasingly willing to engage early in the medical device clinical trial design process, says Sugato De, former senior policy advisor at the FDA’s Office of the Center Director. It’s an often-overlooked resource that can save time and money at the back end of a trial by addressing tiny issues before they grow into big problems.
“I think FDA has proven to be a lot more collaborative in terms of helping these companies design their trials,” De says. There are limits, of course. “You have to come in with a pre-submission with a proposal for an idea, but I’ve seen, particularly over the last five years, [FDA] has been very receptive to having almost working sessions with manufacturers and helping define the requirements for different types of clinical trials.”
While at the agency, De advised senior staff of the Center for Devices and Radiological Health (CDRH) and others on guidance, policy, and regulatory decisions by applying relevant laws, regulations, and standards. He also provided legal and policy guidance to CDRH staff in informing decisions related to emerging public health concerns and sensitive issues such as appeals of premarket decisions and responses to citizen’s petitions, and was a consultant and advisor to CDRH program staff in areas requiring enforcement action. He joined PAREXEL as a principal consultant in October 2016.
De applauds the agency’s openness to developing robust dialogue at the very earliest stages of a clinical trial. At PAREXEL, he provides advice on regulatory strategies to help design clinical trials for medical devices, to sit in on meetings or lead meetings with FDA, and to advise on overall development strategy.
FDA is also further embracing real-world evidence as an important component in trial design and implementation, De says. However, the medical device industry might not yet see it that way.
“My take, and this is my personal opinion, is that I think the medical device industry at large is a little bit skeptical of the extent to which real-world evidence can provide true value in pre-market applications,” De says. “I think they’ve seen FDA have a long history of taking a certain approach with feasibility and pivotal trials, and not accepting observational data as direct evidence in support of effectiveness. My experience, being on the outside, is that the device industry at large is skeptical that real-world evidence can be directly incorporated into clinical trials and provide real value.”
The good news? “I think that that thinking is starting to change, [though] it’s still in the very early stage,” De notes.
De’s been working to bring industry and regulators together to help each better understand how real-world evidence can be used to support the demonstration of safety and effectiveness of a device or treatment in a clinical trial.
“I think it’s fair to say that the FDA has been training its staff to understand the situations in which real-world evidence can provide real value,” De says. “From our early discussions at that time to where we are now, I think FDA’s been a lot more informative and thoughtful in terms of providing that type of feedback.”
Author: Michael Causey