Adaptive Design for Clinical Trials

Accelerate Clinical Development Success with Proven Expertise for Adaptive Clinical Trial Design, Simulation, and Execution

Adaptive design clinical trials are encouraged by the FDA to expedite and improve efficiencies for identifying the clinical benefit of new therapies.   Compared to traditional clinical trial designs, adaptive clinical trial designs are more complex and therefore require careful consideration, rigorous planning, and trial simulations prior to clinical study start-up.  But, adaptive designs offer many potential benefits such as increasing the trial's probability of success, reducing the overall time and cost of the trial, and delivering the right drug to the right patients.

Adaptive Design Clinical Trials

Veristat will provide you with the expertise in the strategic planning, design, optimization, and implementation of your adaptive design.  To embark on an adaptive design trial requires the ability to plan and communicate the design to the regulatory agencies then to communicate and execute the study with the investigational sites and overall project team.  This is where Veristat can help you.   Our experts will:  

  • Utilize trial simulations to recommend various adaptive design options according to the disease area and company portfolio
  • Develop the adaptive design protocol and outline the strategy for working with regulatory authorities
  • Execute the adaptive design including trial monitoring, interim analysis, and suggesting necessary adaptations
  • Provide analysis and interpretation of the adaptive trial data
Adaptive Design Planning, Design, Simulation and Implementation

Adaptive Design as Defined by the FDA

A clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial.

(FDA Guidance - November 2019)

Planning, Simulating, and Implementing Simple and Complex Adaptive Clinical Trial Designs

Types of Adaptive Clinical Trial Designs
   Adaptive Dose-Escalation Design (ADED)    Adaptive Dose Finding
   Adaptive Randomization Design    Dropping Treatment Arm (or Pick the Winner Design)
   Group Sequential Design (GSD)    Population Enrichment Design
   Sample Size Re-Estimation (SSR)    Seamless Phase I/II or II/III Design

 

Benefits of Adaptive Clinical Trial Designs

  • Reduces cost, time & required resources
  • Increases the chance of a successful study via midcourse corrections
  • Reduces time to market
  • Mitigates risks
  • Improves patient safety
  • Facilitates better decision-making

Considerations for Adaptive Clinical Trial Designs

  • Requires more intensive planning
  • Commands more frequent interaction with regulatory agencies
  • Improper execution can introduce bias
  • Confounding can result from adaptations
  • Certain adaptive designs may require larger sample sizes
  • Statistical significance (alpha) penalties apply             

When to Consider Adaptive Designs

While adaptive designs can be advantageous in certain circumstances, they are not suited for every clinical trial. Adaptive designs are highly encouraged for clinical trials in the following applications:

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Oncology trials

Particularly in early phase dose-finding trial designs that use intermediate or accelerated approval endpoints for decision-making
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Rare disease trials

Limited patient populations can use supplemental data from earlier run trials, disease progression analytical models, or previous adult trials
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Trials with large cardiovascular risk

Used for safety monitoring to leverage controls patient from other sources

Learn More with These Resources

Fact Sheet

Adaptive Design Fact Sheet

Adaptive design (AD) trials are increasingly popular as they offer the ability to reduce the overall time and cost of running clinical trials.  And, they improve patient ...

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White Paper

Essential Considerations for Adaptive Design in Clinical ...

In 2016, the Food and Drug Administration (FDA) released final guidance on adaptive design in medical device trials with the intent to provide clarity on adaptive design ...

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Published Article

Interpreting the Regulatory Perspective on Adaptive Designs

In 2010, the FDA published draft guidance on how to conduct an adaptive design clinical trial. In 2016, final guidance was published on a similar topic, while also ...

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