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Products and Solutions:
SurvSoft® (Statistical Tools for Oncology Trial) Software
The SurvSoft® is a package of the advanced statistical tools designed especially for Oncology Drug Clinical Trials. It specifically targeting oncology trial design and data monitoring committee support. SurvSoft® has following features:
Standard DMC Production
- Oncology Trial Design Suite:
- Adaptive Group Sequential Design with application to seamless phase IIB and Phase III combination study
- Adaptive Multi-stage Adaptive Design toxicity monitoring critical values
- Sample size re-estimation
- Pick Winner Design
- Oncology Trial Design Simulator (sample size/power calculation and simulation)
- 3x3 Design Probabilities simulator and CRM modeling; Comparing dose-response shapes, e.g., linear, logistic, Emax, sigmoid Emax, exponential, etc
- Trial Monitoring Tool:
- Event Trial duration Projection (parametric, non-parametric, bootstrapping)
- Advanced Survival Analysis Models:
- Multiple methods for estimating true OS effect from treatment crossover data (Robin’s RPSFT, 2-dimension RPSFT and IPCW etc)
- Bootstrapping projecting Future Efficacy Distribution of P-values and Hazard ratios
- Conditional and Predictive Power Calculation
- Efficacy P-value vs. Time, hazard ratio vs. time (Landmark Analysis)
- Survival Model Distribution Validation and Testing
- PFS and OS joint distribution modeling.
- Quality of Life Analysis for Oncology trials
- Fit pattern mixture model Qol data with non-ignoble missing (missing not at random, MNAR) due to dropout.
- Use worst rank method to handle missing QoL scores due to informed dropouts as an alternative to pattern mixture model.
- Koch randomization based nonparametric methods for time to failure outcomes in multi-center trials
- Multiplicity adjusted confidence intervals for many to one comparisons
- Overall multiplicity adjusted p-values
Standard Tables, Listing and Figures package to support Independent Data Monitoring Committee (DMC). It can include special features such time to event and resolution analysis for AE of special interest and annualized AE tables and figures; Conditional and Predictive power calculation; Future efficacy distribution in terms of P-value or Hazard ratios.
SurvSoft® has been used by several major Pharmaceutical companies. The conclusion and algorithm has been accepted in FDA negotiation. According to the global department head of a major pharmaceutical company, Survsoft® is the statistical package immediately enhanced our argument with FDA in trial design, ultimately speeded up our drug development and reduce development costs.