2020/12/09 by David C. Norris, Norris, David C. · 1 citation
Economics, Econometrics and Finance · Immunology and Microbiology · Mathematics · #Applications (stat.AP) #Biosimilars and Bioanalytical Methods #FOS: Biological sciences #FOS: Computer and information sciences #Health Systems, Economic Evaluations, Quality of Life #Methodology (stat.ME) #Quantitative Methods (q-bio.QM) #Statistical Methods in Clinical Trials
paper · pdf · doi:10.48550/arxiv.2012.05301
openalex publication_date 2020/12/09 · openalex created_date 2025/10/10 · openalex updated_date 2026/07/28
If explicit, formal consideration of clinical pharmacology at all informs the design and conduct of modern oncology dose-finding trials, the designs themselves hardly attest to this. Yet in conducting a trial, investigators affirm that they hold reasonable expectations of participant safety - expectations that necessarily depend on beliefs about how certain pharmacologic parameters are distributed in the study population. Thus, these beliefs are implicit in a trial's presumed conformance to a community standard of safety, and may therefore to some extent be reverse-engineered from trial designs. For one popular form of dose-escalation trial design, I demonstrate here how this may be done.