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Whitepaper: RWE as Confirmatory Evidence for Accelerated Approvals
Since 1992, the FDA has paved the way for life-saving medicines to reach patients swiftly ...
Key Takeaways from the public workshop, “Advancing Real-World Data to Generate Regulatory Grade Real-World Evidence in Oncology”
By Inish O’Doherty and Purva Jain
An evaluation of the replicability of analyses using synthetic health data
This paper published in Scientific Reports describes a study evaluating the replicability ...
FDA releases draft guidance on non-interventional studies for drug and biological products
The Food and Drug Administration (FDA) continues to advance its RWE Program, this time ...
Ten Things I have Learned About Synthetic Data Generation
Khaled El Emam, SVP & GM, Replica Analytics
Aetion’s comments to FDA on recent draft guidance on the substantial evidence standard
This week, Aetion submitted a letter to FDA commenting on the Agency’s recent draft ...
Synthetic Data Summit 2023 | Session 2: Perspectives from Health Regulators
Title: High-Fidelity Synthetic Data Applications for Data Augmentation
Synthetic Data Summit 2023 | Session 5: Applications in Complex Healthcare Settings
Title: Generating Synthetic Data for the NHS
Synthetic Data Summit 2023 | Session 4: Applications of Synthetic Data in the Life Sciences Industry II
Title: Applications of Privacy Enhancing Technology to Data Sharing at a Global ...
Synthetic Data Summit 2023 | Session 3: Applications of Synthetic Data in the Life Sciences Industry I
Title: Applications of Synthetic Data in Supporting Data Products and Analytics for Real ...
Synthetic Data Summit 2023 | Welcome / Opening remarks
Speaker: Khaled El Emam GM and SVP, Replica Analytics; Professor, University of Ottawa
Synthetic Data Summit 2023 | Session 1: Regulating Privacy Risks from Synthetic Data
Title: Assessing the Privacy Risks of Synthetic Data and Other PETs
Synthetic Data Summit 2023 | Session 6: New Applications
Title: Assessing Utility and Building Industry Trust for Imaging Data in Healthcare
Synthetic Data Summit 2023 | Closing Remarks
Speaker: Dorothee Bartels Chief Digital Officer, Aetion
Research Spotlight: A Deep Dive into a Real-World Reproducibility Study
Both real-world data (RWD) and real-world evidence (RWE) studies continue to effectively ...
Partnering to enhance Japanese RWD at a global scale: A Q&A with JMDC
JMDC, a leading Japanese health big data firm, and Aetion® recently announced a ...
Research Spotlight: Navigating Treatment Effectiveness in Rare Oncology with External Control Cohorts
Real-world data (RWD) has proven to be a pivotal tool in understanding patient treatment ...
Evaluating the Utility and Privacy of Synthetic Breast Cancer Clinical Trial Data Sets
This paper published in the Journal of Clinical Oncology: Clinical Cancer Informatics ...
What I saw at DIA RWE 2023
I am just back from Baltimore, Maryland, where I had the joy of attending DIA’s ...
Advancing RWE in Oncology with Aetion’s CARE Initiative
In late 2022, Aetion announced the launch of the Aetion Coalition to Advance Real‐World ...
What I saw at ICPE 2023
I just had the pleasure and privilege of attending the 39th International Conference on ...
Leveraging the SURF screening tool to understand how to identify whether RWE of effectiveness may be acceptable for regulatory decision-making for a clinical development program
Ulka Campbell, Ph.D., is Aetion’s Head of Scientific Strategy. In this role, she uses her ...
Consolidated Reporting Guidelines for Prognostic and Diagnostic Machine Learning Modeling Studies: Development and Validation.
The reporting of machine learning (ML) prognostic and diagnostic modeling studies is ...
Demystifying HIPAA: Techniques for De-identifying Complex Multi-modal Data
Patricia Thaine, Co-Founder & CEO, Private AI