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Wednesday, June 26 • 4:15pm - 5:30pm
#380: Incorporating Patient Input into the Design and Conduct of Clinical Trials

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-712-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will outline efforts, best practices, and key considerations to enhance the incorporation of patient input into the design and conduct of clinical trials.

Learning Objectives

Outline current efforts and opportunities to incorporate patient input into the design and conduct of clinical trials (CT); Discuss approaches, best practices, and key considerations to facilitate patient recruitment, enrollment and retention, and minimize the burden of patient participation in CTs; Identify opportunities to enhance patient engagement and ensure patient input informs CTs.


Meghana Chalasani, MHA


Alexis Reisin Miller, JD

Michelle Tarver, MD, PhD

Marilena Flouri, PhD

Mary Elmer, BSN, MSN, RN

T.J. Sharpe, PMP

avatar for Meghana Chalasani

Meghana Chalasani

Lead, Science Strategies, Office of New Drugs, CDER, FDA
Meghana Chalasani leads the Science Strategies program in the Office of New Drugs in FDA’s Center for Drug Evaluation and Research. She also manages the New Drug Regulatory Program’s Advisory Committee modernization effort. Previously, Meghana worked closely on CDER’s Patient-Focused... Read More →

Alexis Miller

Senior Director, Regulatory Science and Policy, Sanofi
Alexis is a Senior Director for Sanofi Global Regulatory Science & Policy, helping to shape the regulatory and policy environment on topics like patient-focused drug development, digital health technology regulation, and various PDUFA initiatives and FDA program implementation. Prior... Read More →
avatar for Michelle Tarver

Michelle Tarver

Director of Patient Science and Engagement, PSE, CDRH, FDA
The Patient Science and Engagement Program fosters innovative approaches to collecting, analyzing and integrating the patient perspective in the development, evaluation and surveillance of medical devices, including digital health technologies. Her program interacts with digital health... Read More →
avatar for Mary Elmer

Mary Elmer

Executive Director, Patient Innovation Organization, Merck & Co., Inc.
Mary Elmer is the Executive Director of Patient Insights for Oncology at Merck. This group seeks to obtain patient insights and engages patients in optimizing their health, wellbeing, and healthcare outcomes. In her prior role, she led a patient engagement team that brings the voice... Read More →

Marilena Flouri

Mathematical Statistician, OTS, CDER, FDA
Marilena is a statistical reviewer supporting the Division of Dermatology and Dental Products (DDDP) in the Center for Drug Evaluation and Research (CDER) at the FDA. Marilena joined the FDA in 2016 immediately after receiving her Ph.D. in Statistics from the University of Maryland... Read More →
avatar for T.J. Sharpe

T.J. Sharpe

Patient Advocate, Starfish Harbor LLC
T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in his Patient #1 Blog.  He was diagnosed in August 2012 with metastatic melanoma, weeks after his second child was born. He has undergone six surgeries and four immunotherapy treatments over two different... Read More →

Wednesday June 26, 2019 4:15pm - 5:30pm PDT
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Forum |   05: Patient Engagement, Forum