FDA Clears the Way for Home Infusion Patients to Participate in Drug Trials

• By Laurie Watanabe
• Sep 07, 2023

This spring, the U.S. Food & Drug Administration (FDA) announced it would allow patients to participate in infusion-therapy-related clinical trials and studies without requiring them to be in clinical settings.

Connie Sullivan, President/CEO of the National Home Infusion Association (NHIA), called the FDA decision significant.

“During COVID, a lot of clinical trials were not able to go forward,” Sullivan said. “In some cases, with home infusion they were able to continue to keep patients enrolled and not disrupt the trial. “That’s a lot of prior work and investment that [doesn’t need to be] lost by just allowing those patients to infuse their study drug at home.”

Changing the Ways Drugs Are Made & Packaged

Allowing home infusion patients to participate in trials could also help drug manufacturers to better understand the real-world settings in which their products are administered.

“Not only did [allowing home infusion] help continue with the studies, but I think drug manufacturers probably learn a lot about how to create a good drug for the home environment,” Sullivan said. “Most studies are done in health system settings or clinics and offices, and the way you prepare a drug, the way you infuse a drug in a facility setting is very different than how you might approach it in the home setting.

“That’s something we’ve just lived with as an industry for a long time: ‘Why did they write this package insert this way? Why are they preparing it this way? Why are they using so many steps when they could be doing it in a much simpler way, maybe with less fluid?’ Sometimes we scratch our heads and say, ‘This doesn’t make any sense.’ If you’re [administering the drug] in a facility, it’s no big deal. But when you’re in the home, you want things to be as simple as possible, and use as few steps as possible.”

Getting feedback from home infusion payments could give drug manufacturers new information that could benefit all potential patients using that medication.

“When manufacturers have this [home infusion] perspective, other simple things [are important], like how stable is the drug at room temperature?” Sullivan explained. “There are times that you need to mix it before it goes to the home, so you need a few hours. You need preferably 24 hours of stability at room temperature to make sure you’re not going to end up wasting the drug and you have the opportunity to prepare it in a clean environment, maybe eliminating steps for patients who do on their own.

“That’s not something I think a lot of drug companies ever really considered. Maybe they will now that they are actually dealing with those logistics in their clinical trials.”

This story originally appeared in the eBook (digital) edition of DME Pharmacy. For a free subscription, sign up for HME Business’s e-Source newsletter; subscribers automatically receive DME Pharmacy editions.