Patient-Level Data Sharing in Clinical Research

In this webinar, first the principles, opportunities, complexities, and risks of data sharing will be reviewed. Documents from the Pharmaceutical Research and Manufacturers of America and European Federation of Pharmaceutical Industries and Associations (PhRMA and EFPIA 2011) will be referred to, as well as a detailed report from the Institute of Medicine (2015) which discusses the principles underlying data sharing and methods aimed at maximizing benefits and minimizing the risks of data sharing. Essentially, data sharing should protect patient privacy for research participants, preserve the integrity of regulatory systems, and protect intellectual property to maintain incentives for investments in biomedical research. In this context, methods of data de-identification, data standardization (e.g. CDISC), and data coding (i.e., medication procedures, adverse events) will be discussed. Also, the various types of analysis that can be conducted with patient-level data will be outlined.