Guide to Capturing and Managing Data in Digital Therapeutics Trials CASTOREDC.COM | Capturing and Managing Data in Digital Therapeutics Trials | V01 2 Table of Contents 3 Introduction 3 What are DTx? 5 Exploring the DTx regulatory landscape 5 FDA regulations 6 Regulatory challenges specific to DTx 7 Key updates address challenges 7 Payers slow to adopt DTx 8 How DTx can respond 9 Routes to commercialization 9 Commercialization case studies 10 Traditional: FDA clears reSET-O® from Pear Therapeutics. 10 Novel: Big Health’s Sleepio® goes directly to patients before getting clearance 11 Temporary: 2020 FDA emergency authorization for Endeavor by Akili Interactive 11 Choosing a commercialization route 13 DTx clinical trials 13 Why conduct a clini

Join for free to read