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Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials

FDA Law Blog

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. With regard to clinical trial visits and activities, the draft guidance provides examples of the types of approaches that may be possible with a DCT.

Clinic 59
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CDRH Seeks Public Comment on How to Increase Patient Access to At-Home Use Medical Technologies

FDA Law Blog

telemedicine and telehealth solutions (e.g., enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., telemedicine and telehealth solutions (e.g., pregnancy tests, blood glucose monitoring systems, COVID-19 tests, etc.),

Medical 45
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PC Trials at State of Science: Tom LeBlanc, Kate Courtright, & Corita Grudzen

GeriPal

Kate: The problem is we communicate late, we share prognosis late, we elicit goals and values late, so all the time while they’re in the ICU getting prolonged intensive care, we don’t really know that we’re providing goal concordant care, so we wanted to nudge it a little upstream. Eric: Nudge it. Kate: Nudge it. Eric: Okay.

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Telemedicine in a Post-Pandemic World: Joe Rotella, Brooke Calton, Carly Zapata

GeriPal

This DEA is taking 6-months to consider how to move forward vis a vis restrictions and requirements for telehealth in a post-pandemic world. So we’re going to be talking about telemedicine, telehealth for people with serious illness. What was life for you as a provider pre-pandemic? Now is the time to act, dear listeners!