LAUSR

Overview Calls for greater data sharing and transparency in clinical research have intensified in recent years. The potential benefits of data sharing are multifaceted. Increased data transparency can allow research findings to be independently verified; be a valuable resource to address multiple secondary questions; allow combinations with other study data, thereby enabling meta-analytic insights; and facilitate better planning of future research. Data sharing is also consistent with the fundamental principle that science should be a collaborative process used to its maximal common benefit. In June 2017, these altruistic ideals began to have real operational consequences. The International Committee of Medical Journal Editors (ICMJE) stated that clinical trials submitted to ICMJE-compliant journals after July 1, 2018, must include an explicit datasharing statement, and by January 2019, all trials must include a data-sharing plan at trial registration.1 While the ICMJE fell short of requiring full data sharing, the editors commented that it was an “ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk.”1(p2491) This drive toward increased trial transparency mirrors the ambitions already set forth by the National Institutes of Health2 and the National Academy of Sciences.3 While the ethical reasons why data should be shared are clear, making data sharing more practical presents several operational challenges (Table). These include issues with informed consent, questions about how to protect patient privacy, the need for safe, userfriendly, and efficient data platforms, a lack of information on where research data exist and in what form, a lack of common data standards and definitions, and issues with how to credit the investigators who originally collected the data. Thankfully, progress is being made on each of these topics.