Sea Change in Open Science and Data Sharing Leadership by Industry

With remarkable speed, the landscape of open science and data sharing is changing. Fueled by recent evidence that the results of many clinical trials of interventions in common use are never published or reported and that these studies are not missing at random, a persuasive argument has been made that all data from human trials should be available to inform clinical practice.1–6 This would also promote higher quality and higher integrity science, although some urge caution as a result of concerns about unintended adverse consequences.7 In response to these calls for action, some companies have stepped forward and demonstrated leadership. GlaxoSmithKline, in coordination with other companies such as Roche and ViiV, committed early to data sharing.8 Medtronic contracted with our research team, the Yale University Open Data Access Project,9 to conduct external reviews of its clinical trial data for a single product. In addition, we developed policies and procedures to share these data with other investigators. Importantly, Medtronic fully transferred the decision-making authority on how to share the data and who could receive the data to the Yale University Open Data Access Project. Janssen, the pharmaceutical companies of Johnson & Johnson, has now contracted to do the same for the trials under its auspices. Increasingly, other companies are announcing their intention to share data from all published and unpublished clinical trials. On July 24, 2013, the …