Presenter: Aaron Bernstein and Art Gertel

CORE Reference (see http://www.core-reference.org/) was launched in May 2016, to provide interpretational guidance on ICH E3-based CSR authoring that incorporates real-world insights. These include guidance on writing CSRs that share clinical trial data responsibly, and in accordance with current public disclosure requirements. Data disclosure and transparency have become an important concept in new guidance from FDA and EMA. Since its introduction, CORE Reference has been downloaded over 5,400 times. Additionally, there have been a number of other important developments in the area of clinical trial disclosure. Redacted CSRs for over ten products have been published on the EMA’s website. This past December, EMA held a webinar to provide an update on the implementation of the clinical data publication Policy 0070. In February 2017, the Transcelerate Clinical Data Transparency team published three papers on practical implementation of clinical data transparency. Using CORE Reference, along with information from these other recent developments, attendees will be given strategies that can be applied to proactive preparation of CSRs for uses that require redacted personally-identifiable information and company confidential information.

Presenter: Aaron Bernstein