Early Stage and Complex Designs

Early-stage designs in clinical trials focus on investigating the safety, efficacy in humans and find the optimal dosages of new treatments for evaluation in confirmatory Phase III clinical trials. The design choices in early-stage trials can play a crucial role in determining the viability of further development.

Phase I trials focus on establishing the safety profile of a treatment, typically by finding the maximum tolerated dose (MTD) using methods such as i3+3, continual reassessment method or mTPI-2.

Phase II trials seek to find an efficacy signal and select the appropriate doses for Phase III. Phase II is often split into Phase IIa (proof-of-concept) and Phase IIb (dose-finding) trials.

nQuery supports a range of early-stage designs.
 
For Phase I, nQuery supports one-arm trials alongside flexible models such as CRM.

For Phase II, nQuery includes tools for fixed term trials plus common multi-stage Phase IIa designs such as Simon’s, Bryant & Day and Litwin’s.

nQuery also includes MCP-Mod which combines proof-of-concept and dose-finding into a single procedure.