TL37: Data Transparency/Stewardship: The Why's, Where's and How's of the Secondary Use of Patient Data
*Stephen E. Wilson, FDA/CDER/OTS/OB/DBIII 

Keywords: Data Sharing, Secondary Use, Big Data, Transparency, Data Stewardship, Patient-level data

Clinical trials and hospital records are well recognized as important sources of research data with big implications for drug development and public health: the EMA is talking about policies and processes regarding the release of clinical trials data; GSK has announced that they "have developed a web-based system so that researchers from the scientific community can request access to the anonymised patient-level data from ... studies"; and J&J has described its interest in data-sharing through an "agreement with Yale School of Medicine’s Open Data Access (YODA) Project that will extend its commitment to sharing clinical trials data to enhance public health and advance science and medicine." Industry and Government Statisticians need to be aware and involved in what is happening, as we move into this era of Big Data and secondary use. This will an opportunity to learn more about what is happening and to assess the problems/promise associated with these initiatives.