Adaptive Designs

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

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)

Implementing Adaptive Designs

Read a recent case study to learn how and why Veristat was able to implement a biomarker driven adaptive design to help an oncology focused sponsor get to a go/no-go decision quickly for a new therapeutic indication.

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

Articles on Adaptive Designs

To learn more about adaptive designs, read our published articles on Recent Advancements in Adaptive Clinical Trial Designs, Biomarker-Driven Adaptive Designs or Dose Finding Adaptive Designs in early phase Oncology clinical trials.