The leading software platform to enhance dose-finding by designing, analysing, and simulating adaptive model-based study designs

Applying the theory of optimum experimental design, it enables drug developers to quickly and accurately select the most appropriate study doses and patient allocation to increase R&D effectiveness. Discover how you can enhance key operations with ADDPLAN DF 4.0 by exploring its ‘Design,’ ‘Simulation,’ and ‘Analysis’ features.

ICON’s updates to ADDPLAN DF equip clients with the most effective and innovative methodologies in clinical research. The latest version, ADDPLAN DF 4.0, offers several new features, including adaptive capabilities for MCPMod, a powerful statistical approach that has been given a “fit-for-purpose” designation by the US FDA.

Design

Construct optimal dose-finding designs to increase certainty on the minimum effective dose (MED) for your scenarios of interest. With ADDPLAN DF 4.0’s precise model-based design capabilities and design efficiency calculations, you can devise a study that enables you to assess the impact of your drug.

ADDPLAN DF 4.0 provides:

  • Sample size calculation for dose response modelling
  • Optimal allocation ratios for different optimality criteria
  • Efficiency calculations that compare candidate designs to optimal designs
  • Design calculations that take multiple dose-response scenarios into account

Simulation

Evaluate and refine your study design. With ADDPLAN DF 4.0’s simulation capabilities, you can examine the operating characteristics of your chosen analysis and design methods under multiple scenarios.

ADDPLAN DF 4.0 provides functionalities for:

  • Trend testing using model-based, Dunnett, Williams, Marcus, and user-defined contrasts
  • Dose-response modelling and the estimation of the targeted dose using modelling procedures
  • Both targets under one umbrella using the MCPMod methodology
  • The estimation of the maximum tolerable dose using adaptive dose-escalation designs (CRMs)
  • The simulation of adaptive MCPMod trials incorporating adaptive stopping and allocation rules
  • The predictive simulation of ongoing adaptive studies based on interim data (CRMs and MCPMod)

Analysis

Analyse Phase I and Phase II trials by identifying the maximum tolerable dose, the minimum effective dose, the dose-response relation, and any drug-related effects. With ADDPLAN DF 4.0’s flexible capabilities, you can access user-friendly test results, dose estimates, and adaptive allocation proposals for normal, binary, and over disperse-count data.

ADDPLAN DF 4.0 enables:

  • PoC using model-based, Dunnett, Williams, Marcus, and user-defined contrasts
  • Modelling of the dose-response relation and the estimation of the minimum effective dose (MED) using modelling procedures, including Frequentist and Bayesian approaches
  • Combined PoC and modelling, using the MCPMod methodology
  • Adaptive interim analysis in MCPMod trials
  • Bootstrapped MCPMod analysis via simulation frame generate from analysis results
  • Estimation of the MTD using continual reassessment methods, including Bayesian CRM and nCRM with overdose control, probability toxicity interval approaches, or the standard 3+3 design
  • Data import