What a year! Perspectives has explored a myriad of topics this year within clinical development — from adaptive trial design to advice on regulatory submission to clinical data best practices, and so much more — all written by our many expert authors.
As we approach the end of the year, take a look at our most-read articles of 2023:
- It’s Time to Move, Time to Move to Define-XML 2.1
- FDA Guidance on the Design and Conduct of Externally Controlled Trials — What to Watch
- The Facts in the Case of Subject X
- How to Create and Optimize a Clinical Development Plan
- Aligning Clinical Trial Design with Investment Priorities
- Embracing Innovation: Exploring the Design of Umbrella and Basket Trials
- How to Ensure Your Adaptive Trial Is Appropriate for Regulatory Submission
- Adaptive Multi-Arm Multi-Stage Designs: A Comparison of Methods
- Scott Gaines on the Power of Simulation-Guided Design to Handle Increasingly Complex Clinical Trials
- How Target Trial Emulation Can Take the Guesswork Out of Comparative Effect Estimates in Medicare Drug Price Negotiation
- Presenting Clinical Data for Regulatory Submission: A Stats Perspective
- Writing a Successful Study Protocol for Real-World Evidence Studies
- Comparative Effectiveness: Methods and Techniques for Better Decision-Making
- New FDA Guidelines on Pediatric Studies and Potential Effects on Opportunities for Market Exclusivity
- New CADTH Guidance on RWE Is Now Available, but Critical Aspects Are Still Missing
- Dynamic Bayesian Borrowing to Bolster Limited Sample Sizes in Rare Indications
- Bayesian Strategies in Rare Diseases
- Preparing Your Integrated Summaries of Safety and Effectiveness: Best Practices
- Real-Life Data-Sharing and EU Joint Clinical Assessments: Is Closing this Chasm a Mission Impossible?
- Can RWE Help Restore Decades of Health Inequalities? Yes, and Here’s How
A big thank you to all of the authors represented in these posts: Ari Brettman (Blackstone Life Sciences), Louis Dron, Scott Gaines, Miguel Hernán (Harvard University), Åsa Holmgren, Vinusha Kalatharan, Florence Le Maulf, Emma Mackay, James Matcham, Cyrus Mehta, Evie Merinopoulou, Natalia Muehlemann, Iffat Rahman, Grammati Sarri, Jason Simeone, Angelo Tinazzi, and Pantelis Vlachos!
If you haven’t already, make sure to subscribe below — we look forward to sharing more of the latest insights and thought-provoking articles with you next year!
Read more from Perspectives on Enquiry and Evidence:
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Top Real-World Evidence and Real-World Data Topics of 2023
Myth Busting: Master Protocol Edition
The Value of an Optimized Clinical Data Strategy: How Small Changes Can Make a Big Difference
