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Monday, June 19 • 11:00am - 12:15pm
#112: Data Sharing: 2017 and Beyond

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-523-L04-P; CME 1.25; IACET 1.25; RN 1.25

Society is increasingly expecting data transparency in many aspects of life, including clinical data. The European Medicines Agency (EMA) has set a timeframe for lay summaries of trials to be published, while FDA has expressed concerns about inappropriate promotional practices if data are shared with the trial patients prior to FDA review/approval. No clear guidelines or processes established on how to share results back to the trial patients themselves. At the same time, some ethics review boards are expecting individual data results back to the patient, which is a whole different level of data specificity.

Learning Objectives

Discuss the legislations changes that are expected and the impact if there are differences between regulatory agencies; Discuss the mechanisms or barriers for dissemination of individual research results and/or clinical trial lay summaries.

Chair

Rebecca Li, PhD

Speaker

Data Sharing and Transparency: A Global Neutral Platform
Rebecca Li, PhD

Patient Engagement: Meaningful Approaches to Sharing the Data Patients Want and Deserve
Jill McNair, MBA

Plain Language Summaries: Questions, Challenges, and New Developments
Susannah Chang, PhD



Moderators
avatar for Rebecca Li

Rebecca Li

Executive Director, Harvard MRCT Clinical Trials Center, Brigham and Women's Hospital
Rebecca Li, PhD, has over 17 years of experience spanning the entire drug development process with experience in Biotech, Pharma and CRO environments. Dr. Li has served as the Executive Director of the Multi-regional Clinical Trial Center at Harvard since 2012. She is also a co-F... Read More →

Speakers
avatar for Susannah Chang

Susannah Chang

Manager, Oncology Regulatory Medical Writing, Janssen Pharmaceutical Companies of Johnson & Johnson
Susannah is a member of the TransCelerate subteam on Layperson Summaries and has been developing a layperson template for use at Janssen. She received her PhD in neurobiology from UC San Diego, completed postdoctoral research in Germany, and was a research assistant professor at... Read More →
avatar for Rebecca Li

Rebecca Li

Executive Director, Harvard MRCT Clinical Trials Center, Brigham and Women's Hospital
Rebecca Li, PhD, has over 17 years of experience spanning the entire drug development process with experience in Biotech, Pharma and CRO environments. Dr. Li has served as the Executive Director of the Multi-regional Clinical Trial Center at Harvard since 2012. She is also a co-F... Read More →
avatar for Jill McNair

Jill McNair

Senior Director, Patient Engagement, CISCRP
Jill has worked in the non-profit sector for over 20 years. She is the Senior Director, Patient Engagement at CISCRP. In this role, she oversees a team dedicated to helping sponsor companies provide trial results summaries in plain language to study volunteers. She is passionate... Read More →


Monday June 19, 2017 11:00am - 12:15pm
N426b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616