Inclusion of non-inferiority analysis in superiority-based clinical trials with single-arm, two-stage Simon's design.

ABSTRACT:

Introduction

Non-inferiority (NI) analysis is not usually considered in the early phases of clinical development. In some negative phase II trials, a post-hoc NI analysis justified additional phase III trials that were successful. However, the risk of false positive achievements was not controlled in these early phase analyses. We propose to preplan NI analyses in superiority-based Simon's two-stage designs to control type I and II error rates.

Methods

Simulations have been proposed to assess the control of type I and II errors rates with this method. A total of 12,768 two-stage Simon's design trials were constructed based on different assumptions of rejection response probability, desired response probability, type I and II errors, and NI margins. P-value and type II error

SUBMITTER: Sampayo-Cordero M 

PROVIDER: S-EPMC7733004 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature