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 Trial Solutions

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
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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)

Types of Adaptive Clinical Trial Designs

Simple Adaptive Clinical Trial Designs

According to the Tufts CSDD report, across the industry, simple adaptive designs are used on approximately 20% of clinical trials.   Veristat is experienced in with these types of simple adaptive clinical trial designs:
  

  • Group Sequential Design (GSD)
  • Sample Size Re-Estimation (SSR)
  • Adaptive Dose-Escalation Design (ADED)


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

Complex Adaptive Clinical Trial Designs

 Veristat is equally experienced in planning, simulating and implementing the more complex adaptive designs such as:

  • Adaptive Dose Finding
  • Adaptive Randomization Design
  • Dropping Treatment Arm (or Pick The Winner Design)
  • Seamless Phase I/II or II/III Design
  • Population Enrichment Design

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

According to the FDA, adaptive designs are highly encouraged for clinical trials in the following applications:

collaboration_image_handsoverpapers_opt1200pxOncology trials –

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

Rare disease trials –

Limited patient populations can use supplemental data from earlier run trials,
disease progression analytical models or previous adult trials

Trials with large cardiovascular risk –

Used for safety monitoring to leverage control 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 ...

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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 ...

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Published Article
Interpreting the Regulatory Perspective on Adaptive Designs

By John Balser, PhD, Mark ...

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