A comparison of phase I dose-finding designs in clinical trials with monotonicity assumption violation.

Rachid Abbas Caroline RossoniThomas JakiXavier PaolettiPavel Mozgunov

Published in: Clinical trials (London, England) (2020)

Innovative oncology treatments may no longer follow monotonic dose levels ordering which makes standard phase I methods fail. In such a setting, appropriate designs, as the No Monotonicity Assumption or Partial Ordering Continual Reassessment Method designs, should be used to safely determine recommended for phase II dose.

Keyphrases

phase ii
clinical trial
open label
palliative care
phase iii
finite element analysis
double blind