Inferences About Drug Safety in Phase III Trials in Oncology: Examples From Advanced Prostate Cancer.

Joshua Z DragoMithat GönenGita ThanarajasingamChana A SacksMichael J Morris Philip W Kantoff Konrad H Stopsack

Published in: Journal of the National Cancer Institute (2022)

Rigorous comparison of drug safety was precluded by heterogeneity in AE reporting, variation in AE risks in the placebo arms, and lack of inferential statistical methodology, underscoring considerable opportunities to improve how AE data are collected, analyzed, and interpreted in oncology trials.

Keyphrases

phase iii
prostate cancer
open label
adverse drug
clinical trial
palliative care
double blind
placebo controlled
phase ii
radical prostatectomy
electronic health record
single cell
big data
human health
drug induced