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

Adaptive Plus, LLC Biostatistical Consulting Services for: Adaptive Trial Design, Group-Sequential Design, Predictive Biomarker Development, DMCs, Due Diligence, and More

Further Trial-Design & Program-Wide Design Services

Predictive Biomarkers, DMCs, Due Diligence, etc. 

(A) Adaptive Trial Design and Group-Sequential Design Services

  1. For a particular Sponsor's Trial or Program, Provide Biostatistical Consultancy including Assessment of the extent to which Reduced Cost, Decreased Time, and/or Increased Chance of Success may be Obtained from particular Adaptive Clinical Trial Designs, or Group-Sequential Designs.  Wide-ranging options would be considered in this assessment, including one or more of:

    • Sample Size Reassessment

      • Allowing for Interim Effect Size to "Right-Size" the Clinical Trial; and/or

      • Allowing for the Interim Error Variance (or other "nuisance" parameter)

    • Adaptive Selection of the Best Dosage Regimen via a Phase II/III Combination Design approach

    • Adaptive Selection of the Best Patient Population

      • e.g., to determine whether or not to Restrict Enrollment in the Clinical Trial to a pre-specified Enriched Population after the Interim

    • Looks for Early Demonstration of Efficacy to allow trial to Stop for Success at an Earlier Stage (where applicable), and/or looks for Futility Assessment to Cut Losses

      • Stopping Boundaries highly customized to meet Specific Sponsor Needs, allowing for Safety Database Requirements, and Other Needs of the Program

    • Response-Adaptive Randomization in Clinical Trial Design methods such as

      • The Adaptive version of MULTOB or other Adaptive Dose-Finding Methods in Phase II to Increase Chance of Selecting "Best" Dose(s) to Take Into Phase III

      • The modified Continual Reassessment Method or other approaches in Phase I Oncology Design to identify the MTD

    • Dose-Response Modeling (in Phase I or Phase II)

  2. Full Development of Adaptive Trial Designs or Group-Sequential Designs with one or more of the above components, including provision of:

    • All Biostatistical Input on the Design for the Protocol, SAP, any Data Monitoring Committee charter, any IRB supplement

    • Simulation of the Clinical Trial, enabling a quantification of the gains from use of Adaptive Design vs. Traditional Designs

    • Any Adaptive Design Simulation Report, summarizing details from the simulations above, in addition to incorporating documentation on Type 1 Error Control, Bias-Adjusted Estimates, Bias-Adjusted CIs, etc.

Further Trial-Design & Program-Wide Design Services

Predictive Biomarkers, DMCs, Due Diligence, etc. 

(B) Further Adaptive Plus, LLC Services in the Areas of Clinical Trial Design or Program-Wide Design

  1. Biostatistical Consultancy on many Other Areas of Design or Analysis, including:

    • Model-Based Non-Adaptive Design in Phase II (e.g., via the Non-Adaptive version of MULTOB) to Increase Chance of Selecting "Best" Dose(s) to Take Into Phase III Clinical Trial(s)

      • Can still Provide Large Gains When Adaptive Approach is Not Feasible Or is Too Costly

    • Methods to Reduce Sample Size of Clinical Trial(s)  needed to meet regulatory requirements re Adjustment for Multiple Comparisons or Multiple Endpoints

Top of Further Trial-Design & Program-Wide Design Services

 (C) Additional Adaptive Plus, LLC Services

  1. Predictive Biomarker development as an enabler of  Personalized Medicine, making use of:

    • Translational Medicine (cellular signaling mechanisms, including mechanisms of primary or secondary resistance)

    • Statistical Design & Analysis approaches to help derive a fully defined Predictive Biomarker prior to Phase III Clinical Trials

  2. Serve on Data Monitoring Committees for Designs not developed by Adaptive Plus, LLC

    • Available to fill this role on any type of clinical trial design, i.e., regardless of whether based on a Traditional design or on an Adaptive design

  3. Represent Clients in meetings with FDA or EMA

  4. Provide Support Prior to FDA meetings: Critical review of FDA Meeting Packages, participation in "Mock" FDA practice meetings

  5. Clinical Development Plans: Biostatistical co-authoring or review

  6. Due Diligence assessment from a biostatistical perspective for companies considering Investment in particular compounds

    • Includes critical review and assessment of all of sponsor's regulatory correspondence relating to compound, as well as all information on past, ongoing, or planned trials for compound

Further Trial-Design & Program-Wide Design Services

Top of Predictive Biomarkers, DMCs, Due Diligence, etc. 


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