The Adaptive Design Puzzle

By JoAnn Eckhoff

Assembling the Adaptive Puzzle is Challenging

“Multiple factors drive the success of an adaptive design trial. Often, the most brilliant, innovative adaptive model is not enough to reach study goals. One must consider the key issues to be faced within study implementation, conduct, and regulatory placement. Veristat takes on a comprehensive and collaborative approach to study design, while it is also able to manage the implementation and study conduct with scientific integrity, client focus and industry leading expertise.”- John Balser, President of Veristat

Veristat Insights Help Bring the Puzzle Together

Assembling the pieces for a successful adaptive clinical trial is a challenging endeavor. Planning for and executing upon the dynamic steps required to create a successful trial requires the application of intellect, experience, and a pragmatic approach. Through 20 years of designing, implementing, and conducting on over 650 clinical studies across a broad spectrum of therapeutic areas, Veristat provides expert guidance on many adaptive trials. Whether you are focused on oncology, or rare disease, Veristat can lend a hand in solving the puzzle by identifying and helping you answer critical questions that aid in determining if an adaptive design is right for you and how to deliver on the full potential of an adaptive trial.

How We Can Help with Your Adaptive Trial Planning Efforts:

    • Assist with mapping out the development process
    • Identify and answer key questions
    • Advise on best practices and ways to reduce risk
    • Assist with determining critical junctures
    • Provide guidance on adaptive model selection
    • Assist with determining if adaptive design is the best model and which design is the most appropriate
    • Provide strategy to navigate through regulatory barriers

Collaborative Trial Design:

    • Sponsor and Veristat collaborate in an intimate setting to design an optimal trial
    • Work together to achieve the most advantageous protocol
    • Analyze safety and efficacy data throughout trial

Data Collection & Analysis:

    • Analyze and report data at critical junctures
    • Protection of trial integrity
    • Minimize any potential operational bias

Recommendations & Parameter Adjustments:

  • Forecast possible adjustments to parameters
  • Recommend adjustments to dosage, subject population, and sample size at critical milestone points
  • Early study terminations due to futility

For more information on Veristat, and our services, please contact