Decision Support System

Protocol options ranked by Expected Trial Success with full explainability

12

Active Decisions

+18%

Avg Success Improvement

234

Decisions Informed

45

Reports Generated

Protocol Recommendations - NCT-2024-045

1

Biomarker-Stratified Protocol (Recommended)

RecommendedHigh Confidence

Success Probability

54%

Sample Size

n=342

Duration

24mo

Est. Cost

$12.8M

Key Changes:

Restrict enrollment to Biomarker-Positive Group A
Add biomarker screening at enrollment
Reduce sample size from 833 to 342

Advantages

  • 22% increase in success probability
  • 59% reduction in sample size
  • Better ROI

Tradeoffs

  • Extended enrollment timeline (+6 months)
  • Higher screening costs
2

Modified Inclusion Criteria

Medium Confidence

Success Probability

48%

Sample Size

n=556

Duration

21mo

Est. Cost

$15.2M

Key Changes:

Narrow age range to 45-65 years
Require ECOG 0-1 only
Moderate sample size reduction

Advantages

  • 16% increase in success probability
  • Faster enrollment
  • Lower screening costs

Tradeoffs

  • Moderate sample size reduction only
  • Still heterogeneous population
3

Current Protocol (Baseline)

High Confidence

Success Probability

32%

Sample Size

n=833

Duration

18mo

Est. Cost

$18.5M

Advantages

  • Broadest patient pool
  • Fastest enrollment timeline

Tradeoffs

  • Low success probability
  • High failure risk
  • Highest cost

Other Pending Decisions

Dose Selection for Phase III

NCT-2024-038
3 options analyzedDeadline: 2 weeks
High

Interim Analysis Timing

NCT-2024-061
2 options analyzedDeadline: 1 month
Medium

Adaptive Design Implementation

NCT-2024-052
4 options analyzedDeadline: 1 week
High