Foley & Lardner LLP Partner Kyle Faget is quoted in the PharmaVoice article, “FDA’s decentralized trials guidance leaves slate of fresh questions for industry,” discussing the agency’s recently issued guidance which aims to bolster decentralized clinical trial (DCT) adoption.
“Having the FDA come out and give a draft guidance on this topic is real validation for industry that this is real, this is here to stay, this is the future of clinical trials,” noted Faget.
Although the FDA notes in the guidance that the regulatory requirements for DCTs remain the same as for traditional clinical trials, Faget explained that the protocols are actually “much more nuanced.”
“A huge shift is that when conducting clinical trials utilizing telemedicine, there’s an entire geographic patchwork of practice standards that all of a sudden clinicians need to concern themselves with, whereas in the traditional local clinical trial context you already know that the investigator and academic medical center is licensed to practice medicine there and knows the appropriate practice standards,” she said.
For companies moving forward with decentralized trials now, Faget recommends following the FDA guidance closely and keeping in constant contact with the agency over the trial design.