Clinical Trial Disclosure & Data Transparency Conference

Various data sharing initiatives are prompting trial sponsors to share clinical data in the public domain. Indeed, some ICMJE member journals have stated that lack of a positive data sharing statement, upon submission of the manuscript, will prevent manuscript acceptance for publication. The EU General Data Protection Regulation (EU GDPR) is also influencing the data sharing environment, especially for rare diseases. Concepts regarding data sharing that are part of the considerations for sponsors of clinical trials include: i) processes and conditions that could be used to share data including the impact of GDPR, and ii) types of collaborative research that could evolve through data sharing. Sponsor preparedness for data sharing should be an essential component at the early stage of clinical trial planning. This implies communicating and explaining the data sharing requirements within the organization as well as revising internal processes and procedures for data sharing of clinical data.