News & Events

News & Events2021-11-01T13:10:37-04:00


JAMA Oncology: Heterogeneity and Utility of Pharmaceutical Company Sharing of Individual Participant Data Packages

October 6, 2023|

Dr. Ashley Hopkins (Flinders University) and colleagues, including Frank Rockhold (Duke CRI and CRDSA Board Director) and Aaron Mann, show the urgent need for harmonization of the IPD sharing practices of pharmaceutical companies and look ahead to improvements. Read the full paper here:

Evidence Base: CRDSA FDA External Controls Roundtable Analysis and Recommendations

September 23, 2023|

The Evidence Base, a news hub covering topics including real-world data and outcomes research, summarizes the report CRDSA issued following the July 19 roundtable in “CRDSA roundtable analysis and recommendations from the public feedback on the FDA draft external controls guidance” (free registration required). The full CRDSA situation analysis is available in the Resources section.

Can Doctor AI predict cancer, save lives?

August 2, 2023|

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.

Establishing a Basis for Secondary Use Standards for Clinical Trials

March 8, 2023|

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)


Go to Top