In drug development, early phase dose-finding clinical trials are carried out to identify an optimal dose to administer to patients in larger confirmatory clinical trials. Standard trial procedures do not optimize for participant benefit and do not consider participant heterogeneity, despite consequences to participants' health and downstream impacts to under-represented population subgroups. Many novel drugs also do not obey parametric modelling assumptions made in common dose-finding procedures. We present Safe Allocation for Exploration of Treatments SAFE-T, a procedure for adaptive dose-finding that adheres to safety constraints, improves utility for heterogeneous participants, and works well with small sample sizes. SAFE-T flexibly learns non-parametric multi-output Gaussian process models for dose toxicity and efficacy, using Bayesian optimization, and provides accurate final dose recommendations. We provide theoretical guarantees for the satisfaction of safety constraints. Using a comprehensive set of realistic synthetic scenarios, we demonstrate empirically that SAFE-T generally outperforms comparable methods and maintains performance across variations in sample size and subgroup distribution. Finally, we extend SAFE-T to a new adaptive setting, demonstrating its potential to improve traditional clinical trial procedures.

Medicine today is imprecise. Among the top 20 drugs in the U.S., up to 80% of patients are non-responders. The goal of precision health is to provide the right intervention for the right people at the right time. The key to realize this dream is to develop a data-driven, learning system that can instantly incorporate new health information to optimize care delivery and accelerate biomedical discovery. In reality, however, the health ecosystem is mired in overwhelming unstructured data and excruciating manual processing. For example, in cancer, standard of care often fails, and clinical trials are the last hope. Yet less than 3% of patients could find a matching trial, whereas 40% of trial failures simply stem from insufficient recruitment. Discovery is painfully slow as a new drug may take billions of dollars and over a decade to develop.