Policy & Medicine Compliance Update
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MAY 2019 Issue
Issue Summary:
This month the Policy and Medicine Compliance Update is focusing on research. We have articles on research misconduct and real-world evidence which discuss two current and important research topics. We also have Part 2 of our series on compliance risk assessments, which focuses this month on data analytics. Finally, we round out the issue with updates on the drug pricing hearings and the latest case impacting qui tam litigation
FEATURE
Scientific Inquiry or Legal Jeopardy? – Research Misconduct Compliance after the Duke Settlement
By Carolyn Greene, Staff Writer, Policy & Medicine Compliance Update
Summary: Duke University recently agreed to a pay a $112.5 million fine to settle allegations relating to research misconduct involving falsified data. In this article, we review compliance practices relating to such allegations of research misconduct, including how the National Institutes of Health requires that institutions handle inquiries into and reporting practices surrounding these allegations, and the impact of False Claims Act liability on the area of research misconduct compliance.
TAGS: Research Misconduct, NIH, Duke, False Claims
Research
Data in the “Real World” – Present Day
By Dr. Seth B. Whitelaw, Editor, Policy & Medicine Compliance Update
Summary: Real world evidence is playing an increasing role in the development and marketing of pharmaceutical, medical devices. This is the first of a two-part series examining what the present and future may hold and the implications for life science compliance professionals.
TAGS: Real-World Evidence, Real-World Data, Big Data, Research
