Industry Verticals · Healthcare Management

BioForge Phase III — Trial Design Under FDA & EMA

Architect a Phase III oncology trial for BFG-722 (HER2-mt NSCLC) that satisfies FDA accelerated-approval, EMA centralised, and IDMC charter standards under a 9-12 month competitor lead. Three rounds: trial design, FDA+EMA dialog, IDMC charter and strategic-pivot memo.

3 rounds Executive English, Español
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Preview

Who it is for

An advanced simulation for participants used to working with the main frameworks and trade-offs of the subject, designed for executive education and experienced professionals.

How a session runs

  1. The instructor creates a session from the Eureka dashboard and invites the participants.
  2. Participants play 3 rounds. In each one they submit their decisions and the simulation calculates the results. The first round opens with: Trial Design.
  3. The simulation can be run in English, Español.
  4. The instructor follows each participant's progress and results from the dashboard, and uses the class results for the debrief.

Decisions participants make

The decisions participants make during the simulation:

  • Endpoint hierarchy
  • Comparator arm
  • Group sequential design with alpha-spending
  • Sample-size re-estimation at 50% interim
  • Adaptive population enrichment (pre-specified biomarker subgroup)
  • ICH E9(R1) estimands explicitly specified
  • FDA Question 1 — ORR co-primary gatekeeper
  • FDA Question 2 — Alpha-spending function
  • EMA SAWP — DS-8201 head-to-head response
  • EU5 enrollment minimum (%)

Subjects covered

Designed for courses in Healthcare Management.

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