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In May 2019, Dr. @rschilsky & I co-chaired the #AAADV19 Workshop Plenary Session "Decentralized #ClinicalTrials: The Future is Now." An incredible group of panelists from academia, industry, govt, & patient #advocacy 👇discussed the rationale, challenges, & opportunities of DCTs. Image
No one knew yet that the #COVID19 #pandemic was just around the corner. In Mar 2020, FDA released a guidance on conduct of #clinicaltrials during the pandemic: fda.gov/media/136238/d…, & colleagues wrote about the impact on #OncTwitter trials: ncbi.nlm.nih.gov/pmc/articles/P…. /2
FDA has now released a draft guidance on decentralized #clinicaltrials for drugs, biological products, & devices covering #telehealth, remote assessments, consent, shipping of IP, & more: fda.gov/media/167696/d…. #MedTwitter #regulatory #drugdevelopment Image
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