Adaptive Plus, LLC
Adaptive Trial Design
Group-Sequential Design
Plus Predictive Biomarkers, DMCs, & More
Cutting Edge Biostatistical Consulting for Clinical Trials

Founded by Jonathan R. Smith, Ph.D. in 2007 to help sponsors, where possible, achieve one or more of the following:

  • Decrease Cost of a Trial or Program, and/or Shorten the expected Duration of a Trial

  • Cut expected Time to NDA Submission

  • Increase the Chance that Phase III Trial will be Positive for Efficacy and so Decrease Late-Stage Attrition

  • Increase the Chance that Phase II Trial(s) Identify Most Appropriate Dose(s) to Take Into Phase III

  • Increase the Chance that Program Identifies any Subpopulation(s) where Drug Benefit-Risk is Much Greater

  • Increase expected Net Present Value for the Compound

Makes use of techniques such as the following to achieve these Gains:

  • Adaptive Trial Designs of many different types

  • Group-Sequential Designs, incorporating Early Efficacy Looks for Success and/or Futility

  • Predictive Biomarker Development

  • Simulation of the Clinical Trial under multiple scenarios

  • Other Innovative Design approaches at the Trial or Program Level

  • Many types of Modeling, including Dose-Response Modeling

  • Improved Analysis, particularly for dealing with Regulatory Requirements re Multiplicity


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