DIA: Driving Insights to Action
Science:Life Sciences
“The ground is shifting in terms of how we will continue using randomized clinical trial data and real-world data in many different disease settings,” says Veronica Miller, co-author of Use of External Controls in FDA Regulatory Decision Making. In this research article, Miller (Forum for Collaborative Research) and Adora Ndu (Bridgebio Pharma, Inc.) describe where and how FDA has used external controls to support development and approval of drugs for rare and pediatric diseases. “We're seeing, not just in rare diseases but in many other diseases, this coming together of what used to be totally separate silos. In part, that's facilitated through electronic health records and other mechanisms of capturing data and being able to follow data at a bigger level, but also just because of understanding the importance of clinical data.”
DIA 2016 Co-Chair: "A Market for Ideas" in a Global Forum
Advances and Best Practices in Communications with Consumers and Health Care Professionals
Challenges in Deploying a Global Pharmacovigilance System
Challenges in Adverse Event Reporting and the Role of Specialty Pharmacies
Access & Attitude to Clinical Trial Technology: The Global Investigator Perspective
What Precision Medicine Means Today and Will Mean Tomorrow for Patient Care
FDA Director of Division of Online Communications, CDER, Discusses FDA's First Mobile App
Pediatric Drug Development & Therapeutics in September TIRS
TransCelerate BioPharma Clinical Quality Management System Conceptual Framework
Patient Engagement and Rare Diseases at DIA
Ethical Considerations in Policies on Drug, Device, and Companion Diagnostics Development
Medical Communications Transformation and Impact on Health Care Community
Challenging the Value of Source Data Verification
The Impact of Collaborative and Risk Sharing Innovation Approaches on Clinical and Regulatory Cycle Times
How to Get Published with DIA
Perspectives on Statistics
An Expanded Role for Patients in Clinical Trial Design
Women and Children First—Time for a Coalition to Address a Substantial Patient Need
PhactMI Strives to Bring Medical Information Transparency to the Health Care Community
Clinical Safety and Pharmacovigilance
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