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Best Practices for Adaptive Clinical Trials: FDA Guidance and Philosophy

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February 2012
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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 C

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 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:

  • Prospective Planning: How to anticipate the types of modification that will occur in trial design to avoid what the FDA does not want to see in terms of making changes to dosing, exclusion criteria, target subject populations and other criteria.
  • Trial Models: What the FDA considers valid vs. invalid models for adaptive trial design — what questions adaptive designs raise — and how best to answer them.
  • Controls: How to factor in bias and error controls early in the design phase to present the FDA with assurance that sponsors won’t simply see what they want to see in the interim results.
  • Protocols and Statistical Analysis Plans: How to pull all elements of the adaptive clinical trial together into protocols and plans that support the trial effectively from startup through reviews and final data analysis.
  • Trouble Shooting: How to spot and avoid common difficulties that may arise in adaptive trials; the FDA’s central concerns — the agency’s most frequent complaints about adaptive trials.

Don’t let technical problems derail your adaptive clinical trial! Rely on this management report for the best practices to help you enjoy maximum agility in winning approval and bringing new drugs to targeted populations.

ROs 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 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:

  • Prospective Planning: How to anticipate the types of modification that will occur in trial design to avoid what the FDA does not want to see in terms of making changes to dosing, exclusion criteria, target subject populations and other criteria.
  • Trial Models: What the FDA considers valid vs. invalid models for adaptive trial design — what questions adaptive designs raise — and how best to answer them.
  • Controls: How to factor in bias and error controls early in the design phase to present the FDA with assurance that sponsors won’t simply see what they want to see in the interim results.
  • Protocols and Statistical Analysis Plans: How to pull all elements of the adaptive clinical trial together into protocols and plans that support the trial effectively from startup through reviews and final data analysis.
  • Trouble Shooting: How to spot and avoid common difficulties that may arise in adaptive trials; the FDA’s central concerns — the agency’s most frequent complaints about adaptive trials.

Don’t let technical problems derail your adaptive clinical trial! Rely on this management report for the best practices to help you enjoy maximum agility in winning approval and bringing new drugs to targeted populations.

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