Remember, the vast majority of pivotal Phase 3 trials are funded by for-profit companies.

Twenty years ago, Rick Ng's Drugs: From Discovery to Approval cited benchmarks of roughly $1 billion, 10 years, and 10,000 candidates to get a single drug across the line. Today, estimates easily run $2 billion to $4 billion.

Given that level of financial pressure, especially in Phase 3 where a single failure can wipe out a biotech company, assuming humans "follow the spirit of the trial process" is wishful thinking. Humans already exploit the system through p-hacking, shifting surrogate endpoints, and cherry-picking subgroups. An AI gaming trial parameters wouldn't be a new problem. It would just be an automated version of what sponsors already do.