Early Stage and Complex Designs

Sample size & operating characteristics for Phase I, II & Seamless Designs (MAMS)

Robust Trial Outcomes

Multi-Stage Designs

Find sample size and optimal futility exit rules for Phase IIa designs using methods such as Simon’s Design, Fleming’s Design and Litwin’s Designs 


Seamless Transitions

Multi-Arm Multi-Stage (MAMS) Designs to select doses for Phase III or MCP-Mod to consolidate proof-of-concept and dose-finding stages in Phase II trials

Study Size for Phase I MTD

Find the sample size needed to find the maximum tolerated dose using the continual reassessment method (CRM)


Design Adaptive Early Stage and Seamless trials to ensure quick decisions and reduced costs


Futility Analysis at Phase IIa

Stop unpromising therapies fast using methods such as Simon’s Design


Evaluate Phase II Toxicity

Use Bryant & Day to provide stopping rules based on efficacy and toxicity


Test PFS at Phase II

Litwin’s Design extends Phase II evaluation to survival outcomes


Combine IIa/IIb with MCP-Mod

MCP-Mod merges proof-of-concept and dose-finding into single robust procedure


Seamless II/III MAMS Designs

Use MAMS methods to drop unpromising treatments or doses before Phase III


Phase I MTD 

Find sample size needed for continual reassessment model (CRM)

Multi-Arm Multi-Stage Design(MAMS) in nQuery

MAMS trials can provide a quick and efficient evaluation of multiple treatments, targets or doses under a single study protocol

Frequently Asked Questions

What is the significance of early-stage designs in clinical trials?

What types of early-stage designs can be accommodated by nQuery?

Recommended Resources

Expert Insights

A Comprehensive Guide to Sample Size

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Trial Design Templates

Statistical & Therapeutic Examples

Trial Design Templates

Free Training

Designing Robust Group Sequential Trials

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