Adaptive Design for Clinical Trials

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

Adaptive design clinical trials are increasingly popular and are now being encouraged by the FDA to expedite and improve efficiencies for identifying the clinical benefit of new therapies.   Compared to classical 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.  However, adaptive designs can 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
What is an Adaptive Design Clinical Trial? Adaptive Design Definition

Adaptive Clinical Trial Design Types

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             

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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