On Tuesday, April 8 at 1PM ET, we will be joined by Dr. Chris Boone of Avalere Health for a webinar on Clinical Trial Data Transparency: Explaining Governance Considerations for Public Data Sharing.
Clinical trials are extremely valuable as the primary data source for seeking regulatory approval of products. Historically, regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have been the sole recipients of clinical trial data; conversely, there has been a recent push from various stakeholder groups to open access to clinical trial data to non-regulatory researchers as an act of ethical responsibility to patients, a contribution to public health, and a demonstrated commitment to advancing the science.
Moreover, the EMA has taken the position that “clinical trial data is not commercial confidential information.” In December 2013, the European Medicines Agency (EMA) elected to forge ahead with its objectives of full transparency of clinical trial data. This decision, per the EMA, was based primarily on the short- and long-term benefits to the patient community. However, the EMA has acknowledged the need to conduct further analyses to identify and address barriers to certain aspects of this proposal. Some of the barriers include developing a sound approach for de-identifying patient data, adopting universal clinical trial data format, and managing the proactive and non-selective access and security of clinical data once collected.
OBJECTIVES:
Avalere recognizes the current landscape and the drive of data transparency. This session provides an overview of the clinical trial data transparency discussion in the EU and discusses some of the key barriers to effectively governing the process for collecting, storing, securing, authorizing access, and auditing the data from a regulatory perspective. In particular, we will:
- Review the rationales for and benefits/risks of clinical trial data transparency;
- Discuss responsible use of public data sharing;
- Analyze key barriers to overcome with data collection and standardization;
- Describe legal and policy implications allowing public access to data; and
- Identify and describe reasonable data sharing models.
Click here to register for the webinar.
Presenter Bio
Chris Boone, PhD, MSHA, FACHE
Chris Boone is a Vice-President in Avalere’s Evidence Translation and Implementation practice. He is a recognized expert in health systems, health informatics, health IT policy, and the use of electronic clinical data to generate clinical and scientific evidence for quality improvement and patient-centered outcomes research efforts. Chris merges his knowledge of electronic clinical systems in provider settings with his knowledge of health IT policy to construct systems that generate relevant real world evidence.
Prior to Avalere, he was the National Director of Outpatient Quality and Health IT for the American Heart Association (AHA).
Dr. Boone is a sitting member on the the advisory board of the American College of Clinical Oncology’s CancerLinQ (rapid learning health system project), the advisory board for the eHealth Equity Initiative, the Board of Directors for the National Patient Advocate Foundation and Patient Advocate Foundation, and the Translation and Communication Committee for Academy Health. In addition, he is a former sitting member on the ONC’s Health IT Policy Committee.
Dr. Boone holds a Bachelor of Science in Management Information Systems from the University of Tulsa, a Master of Science in Healthcare Administration from the University of Texas at Arlington, and a Doctor of Philosophy in Public Affairs and Health Policy from the University of Texas at Dallas. In addition, he is a fellow of the American College of Healthcare Executives (FACHE), a certified professional of healthcare information and management systems (CPHIMS), and a project management professional (PMP).