Capture diet, fibre and antibiotic exposure in every immunotherapy pivotal trial
Gut bacteria appear to influence whether immunotherapy works, and diet and antibiotics shape gut bacteria. Yet almost no drug trial records what patients ate or which antibiotics they took. Recording it would cost almost nothing.
Fibre intake, probiotic use, antibiotics and proton-pump inhibitors are each associated with checkpoint-inhibitor outcomes in observational cohorts, but the data come from single centres with recall questionnaires. Pivotal trials enrol tens of thousands of patients under protocol with concomitant medication logs already captured; adding a short validated diet screener and banking a baseline stool sample would generate the largest and cleanest dataset on host factors in immunotherapy, and allow stratified or covariate-adjusted analyses that could explain part of the variability in response.
- No one can predict who responds to immunotherapy · Checkpoint drugs cure some patients and do nothing for most. We still cannot tell the two apart before treating.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.
- Data silos · Records, scans, genomes and outcomes sit in separate systems that cannot talk. Every patient's experience is lost to the next.