Addressing Emerging Challenges in Clinical Trial Data Sharing

Privacy Analytics, IMS Health and the Electronic Health Information Laboratory are jointly organizing a symposium to address emerging privacy challenges in clinical trial data sharing. The one-day event, Experiences and Methods in Sharing Clinical Trial Data, will bring together pharmaceutical industry professionals with experts and preeminent academics in data sharing, privacy, and de-identification. The goal is to address operational and privacy concerns associated with the new regulations and challenges in Europe and the United States, while ensuring participant confidentiality and meeting growing demand for transparency in clinical trials.

“The pharmaceutical industry is under pressure to make clinical trial data more readily available under both mandatory and voluntary approaches,” said Dr. Khaled El Emam, Founder, Privacy Analytics, and one of only a handful of individual experts in North America qualified to anonymize Protected Health Information under the HIPAA Privacy Rule. “Keeping pace with new regulations to disclose data from clinical studies, while remaining compliant with privacy regulations in multiple jurisdictions is challenging — and raises many questions. Executives responsible for trial data disclosure, medical writers and compliance or privacy professionals, are left searching for reliable approaches to manage the risks associated with sharing patient data.”

On the Agenda

The symposium will address pharmaceutical industry concerns regarding legal, regulatory and public pressures, and provide education on safe, compliant and transparent data sharing practices. Topics to be covered include:

  • Implementing the European Medicine’s Agency’s (EMA) policy 0070;
  • The implications of EMA policy 0043 on protecting patient information;
  • The International Committee of Medical Journal Editors’ (ICMJE) proposal that de-identifying individual patient data (IPD) be shared as a condition of publication in medical journals;
  • The desire to leverage data holdings for secondary uses safely and securely;
  • Legal liability;
  • Scaling processes for efficiency and cost effectiveness; and,
  • Contemporary standards for anonymizing trial data

“Responsible data sharing begins with de-identification,” said El Emam. “De-identifying data not only serves to protect the privacy of patients, but ensures the utility of data is sufficient to produce results consistent with the original data. It also provides a well-documented and defensible approach.”

Some of our Speakers

  • Khaled Emam, Founder, Privacy Analytics and senior investigator at the Children’s Hospital of Eastern Ontario Research Institute’s Electronic Health Information Laboratory
  • Bradley Malin, Vice Chair for Research and Associate Professor of Biomedical Informatics, School of Medicine at VanderbiltUniversity.
  • David Handelsman, Vice President of Development, Project Data Sphere
  • Frank W. Rockhold, Professor of Biostatistics and Bioinformatics, Duke Clinical Research Institute

The Symposium will take place on Monday, October 24th, 2016 from 9:00 a.m. to 4:00 p.m. in Philadelphia, PA. For complete details, click here to download the event notice.

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