News
Clinical Research Data Sharing Alliance Hosts Virtual Summit
Aaron Mann2024-07-23T13:17:52-04:00February 20, 2024|
PISCATAWAY, NJ, February 20, 2024 – The Clinical Research Data Sharing Alliance (CRDSA) is convening leading experts from the scientific and regulatory communities for a virtual summit on the latest developments in patient-level data sharing and data reuse. (more…)
JAMA Oncology: Heterogeneity and Utility of Pharmaceutical Company Sharing of Individual Participant Data Packages
Aaron Mann2023-10-26T15:43:00-04:00October 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: https://jamanetwork.com/journals/jamaoncology/fullarticle/2810120
Evidence Base: CRDSA FDA External Controls Roundtable Analysis and Recommendations
Aaron Mann2023-10-26T15:24:55-04:00September 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.
Pink Sheet Regulatory Analysis: CRDSA’s External Controls Roundtable
Aaron Mann2024-03-18T15:38:35-04:00August 24, 2023|
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.
Can Doctor AI predict cancer, save lives?
Aaron Mann2023-08-20T17:32:00-04:00August 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.
Assessing Innovation: How Pharma Makes Tech Investment Decisions
Aaron Mann2023-10-26T15:08:32-04:00July 15, 2023|
Read Bio-IT World’s write-up of the plenary keynote panel that featured CRDSA Board Director Peter Mesenbrink (Novartis) and was moderated by Aaron Mann.