Top Real-World Evidence and Real-World Data Topics of 2023

Perspectives covers a wide range of topics related to real-world evidence and real-world data, from overcoming health inequalities in product development to the use of externally controlled trials to the expanding role of artificial intelligence, and much more. Here are some of the top topics covered this year:

Overcoming Health Inequalities in Clinical Trial Development

Mind the Health Gap: Is It Time to Reliably Measure the Impact of Health Inequity in Product Development and Assessment? Yes, It Is.

FDA Increases Calls for Manufacturers to Ensure Trial Diversity, but Does It Fall Short of Addressing Health Inequalities in Product Development?

Can RWE Help Restore Decades of Health Inequalities? Yes, and Here’s How

Externally Controlled Trials

FDA Guidance on the Design and Conduct of Externally Controlled Trials — What to Watch

Data Challenges (and Solutions) for Externally Controlled Trials

Reflections on the RCT DUPLICATE Study and Increasing Confidence in Real-World Evidence

Artificial Intelligence and Machine Learning

Reinforcement Learning: A Promising Tool for Predicting Optimal Treatment in Complex Diseases

Embracing AI and ML in Medical Devices: FDA’s Total Product Lifecycle-Based Regulatory Framework

Looking to the Future — Improving Diagnosis and Prognosis of Eye Conditions with Artificial Intelligence

Guidance considerations

Unravelling PICO: The Pillars of the European Joint Clinical Assessment

Real-Life Data-Sharing and EU Joint Clinical Assessments: Is Closing this Chasm a Mission Impossible?

New CADTH Guidance on RWE Is Now Available, but Critical Aspects Are Still Missing

Claims Data

Retrospective Claims Data Analysis Unlocks Discovery in Multiple Sclerosis Research

New Linked Database Expands Potential of RWE: A Unique Opportunity for Multiple Sclerosis Research

Linked Data Studies: Improving the Way We Do Observational Research in Germany

Comparative Effectiveness

Navigating Comparative Effectiveness in the Inflation Reduction Act: Methodological Approaches for Healthcare Challenges

How Target Trial Emulation Can Take the Guesswork Out of Comparative Effect Estimates in Medicare Drug Price Negotiation

Comparative Effectiveness: Methods and Techniques for Better Decision-Making

A big thank you to all of the authors represented in these posts: Paul Arora (University of Toronto), Louis Dron, Andreas Freitag, Alind Gupta, Miguel Hernán (Harvard University), Yannis Jemiai, Vinusha Kalatharan, Evie Merinopoulou, Haridarshan Patel (Horizon Therapeutics), Maria Rizzo, Grammati Sarri, Jason Simeone, David Smalbrugge, Fei Tang, Russanthy Velummailum, and Thomas Wilke.

If you’re interested in more topics regarding real-world evidence and real-world data, take a look at our posts and don’t forget to subscribe to our newsletter below to stay up-to-date on upcoming insights!

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