News & Events

This Pink Sheet analysis (subscription needed): “US FDA’s External Controls Guidance Should Include Hybrid Designs, Experts Say”  provides an in-depth recap of the CRDSA’s July 19th roundtable.

This  Al Jazeera “Big Idea” feature highlights the AI data challenges: “Central to the challenges confronting AI in medicine are three major limitations in the data used to develop it: paucity, access restrictions and quality” and calls out CRDSA’s work to drive change.

Read Bio-IT World’s write of the plenary keynote panel that featured CRDSA Board Director Peter Mesenbrink (Novartis) and was moderated by Aaron Mann.

Applied Clinical Trials Online has published CRDSA’s paper “Establishing a basis for secondary use standards for clinical trials.” The paper reports on CRDSA’s 2022 survey of biopharma and academic researchers, and discusses how common standards can accelerate the reuse of trial data, benefiting both data contributors and the research community.  CRDSA recognizes the incredible contribution of the authoring team including: Ernest Odame (Takeda), Tracy Burgess (Roche), Luk Arbuckle and Andrei Belcin Privacy Analytics), Peter Mesenbrink (Novartis); and Ramona Walls (C-Path)

Regulatory Focus, a publication of Regulatory Affairs Professional Society (RAPS), interviews CRDSA CEO Aaron Mann and COTA Healthcare’s Chief Medical Officer C.K. Wang, MD, on CRDSA’s demonstration project that seeks to establish best practices around the use of clinical trial and real-world data (RWD) in building supplemental control arms.

The recording of the webinar, “A Review of BioPharma Sponsor Data Sharing Policies and Protection Methodologies” is now available. The webinar featured the authors from CRDSA’s white paper, exploring the papers  findings, which examine sponsors’ data sharing policies and protection methodologies as well as reflections on actionable steps for sponsors and secondary analysis researchers alike.