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Tuesday, June 21 • 1:45pm - 2:45pm
#244: Planning and Conducting Efficient, High-Quality Decentralized Trials: A Multi-Stakeholder Initiative

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-567-L04-P ; CME 1.00; RN 1.00

Building on decentralized clinical trials work, this session offers multi-stakeholder insights, updated recommendations, and case examples for incorporating decentralized elements in trials, from tele-visits to mobile HCPs and D2P shipping.

Learning Objectives

Discuss new multi-stakeholder recommendations and best practices for effectively incorporating decentralized elements into clinical trials from the earliest stages of trial design; Identify current challenges to operationalizing decentralized elements, and opportunities to address these challenges in individual trials and programs, as well as through continued multi-stakeholder collaboration.

Chair

Megan Doyle, JD, MPH

Speaker

Planning and Conducting DCTs: An Industry Perspective
Reem Yunis, PhD

Patient Perspective
Philip John Green

FDA Perspective
Susanne R. Goldstein, MD



Speakers
avatar for Megan Doyle

Megan Doyle

Global Policy Lead, Digital Health, Diagnostics, Oncology, & Combination Product, Amgen, United States
Megan Doyle is an attorney and policy professional with more than 13 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public... Read More →
SG

Susanne Goldstein

Medical Officer, ON, Office of New Drugs, CDER, FDA, United States
Currently, I am a Medical Officer at FDA, CDER, Division of Neurology Products, involved in the scientific and regulatory review of of investigational new drug applications. I received my BA in Psychology from Brown University and my MD form Brown University School of Medicine. I... Read More →
avatar for Philip Green

Philip Green

Steering Committee Patient Representative, CTTI, United States
Phil was diagnosed with ALS in August of 2018 and immediately dedicated himself to making a difference in the fight against ALS. Phil is active with multiple ALS organizations and institutions (Team Gleason, I AM ALS, Augie’s Quest, ALS TDI, ALS Cure Project, UW Medicine, ALSA... Read More →
avatar for Reem Yunis

Reem Yunis

Vice President, Digital Clinical Measures, Medable, United States
Dr. Yunis is a scientist with multidisciplinary training and experience in mechanism of diseases. Reem enjoys working in startups bringing forward long term vision and strategies. At Medable, she works cross-functionally with engineers, product development, regulatory, and data science... Read More →


Tuesday June 21, 2022 1:45pm - 2:45pm CDT
Room 179 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session