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Data Sharing: 2017 and Beyond
Session Chair(s)
Rebecca Li, PHD
Executive Director, Center for Global Clinical Research Data, Vivli , United States
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 Objective : 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.
Speaker(s)
Data Sharing and Transparency: A Global Neutral Platform
Executive Director, Center for Global Clinical Research Data, Vivli , United States
Patient Engagement: Meaningful Approaches to Sharing the Data Patients Want and Deserve
Key Account Director, Scott Clinical, United States
Plain Language Summaries: Questions, Challenges, and New Developments
Manager, Oncology Regulatory Medical Writing, Janssen Pharmaceutical Companies of Johnson & Johnson, United States
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