Clinical Trial Disclosure and Data Transparency Workshop
December 7 - 8, 2016 - London CHDIA EMEA
emea@diaglobal.org
Phone:+41612255151
Transparency of clinical trial information is taking on new dimensions, including the release of anonymized participant-level data and return of results to study participants. Clinical trial sponsors and academia are facing a host of new registration requirements in the EU and the US. There is a call to share their clinical trial data and industry's initiatives on data sharing are also expanding. This increased transparency and use of information from clinical trials brings with it new data use opportunities and operational challenges for industry and academia. The continuing expansion of disclosure requirements in the US and EU leave many sponsors and academia considering disclosure strategy, developing operational measures, and looking for efficient ways to manage dissemination of clinical trial protocol information and results data. The users of clinical trial information is varied which provides both opportunities and challenges for how the information is provided. Learning objectives Learn about the latest developments relating to the EU Clinical Trial Regulation and its impact on transparency, and trends in the global clinical trial disclosure world Benefit from the various perspectives on clinical trial transparency of large, mid-sized, and smaller sponsor organizations Leverage best practices on implementation of clinical trial disclosure through case studies by exchanging views between regulators, industry, patients, academia and other stakeholders