Adaptive clinical trials are one of today’s best tools for finding new drugs that improve on existing therapies in targeted populations. Still, avoiding rejections means sponsors and CROs must know in advance what the FDA does — and doesn’t — want to see in everything from design through final data analysis.
That’s a little easier now that the FDA has begun to identify the adaptive trial models that it finds to be valid.
Now, take your own planning and preparation to the next level by turning the FDA’s preferences into rock-solid best practices for speeding your approval.
Before you begin to modify an existing trial, this new report from FDAnews maps out the specific planning and preparation it takes to win FDA approval for adaptive clinical trials. By combining a concise overview with a detailed analysis of FDA’s preferences, this one report advises you on everything thing from the best trial model to use to the best way to avoid technical problems with final data analysis.
Buy now to turn the FDA’s own guidance and examples of acceptable modifications into real-world best practices for “rejection-proofing” your adaptive clinical trials, including:
Don’t let technical problems derail your adaptive clinical trial! Rely on this new management report for the best practices to help you enjoy maximum agility in winning approval and bringing new drugs to targeted populations.
Best Practices for Adaptive Clinical Trials: FDA Guidance and Philosophy is offered by FDAnews in print or PDF format for $377.
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