Adaptive Trial Design & Group-Sequential Design Services
Further Trial-Design & Program-Wide Design Services
Predictive Biomarkers, DMCs, Due Diligence, etc.
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)
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.
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Further Trial-Design & Program-Wide Design Services
Predictive Biomarkers, DMCs, Due Diligence, etc.
Biostatistical Consultancy on many Other Areas of Design or Analysis, including:
Optimization of the Whole Clinical Program, e.g., to either:
All of this subject to constraints of meeting efficacy & safety needs for the NDA submission, for either approach
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
Adaptive Trial Design & Group-Sequential Design Services
Top of Further Trial-Design & Program-Wide Design Services
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
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
Represent Clients in meetings with FDA or EMA
Provide Support Prior to FDA meetings: Critical review of FDA Meeting Packages, participation in "Mock" FDA practice meetings
Clinical Development Plans: Biostatistical co-authoring or review
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
Adaptive Trial Design & Group-Sequential Design Services
Further Trial-Design & Program-Wide Design Services
Top of Predictive Biomarkers, DMCs, Due Diligence, etc.