Adaptive Designs for Clinical Trials

Compared to classical clinical trial designs, adaptive clinical trial designs can be much more complex and therefore require careful consideration, rigorious planning and trial simulations prior to study start-up.  However, adaptive designs can offer many potential benefits including: 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 Clinical Trial Design Planning & Implementation

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
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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)


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To learn more about adaptive designs or to explore whether an adaptive design would be beneficial for your trial or development program,  reach out to us today.

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Complex Adaptive Clinical Trial Designs

 Veristat is equally eperienced 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

More on Adaptive Designs

To learn more about adaptive designs, read our latest published articles on adaptive designs.

 

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