English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Global: Zendy Plus annual

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Global: Zendy Plus monthly

Global: Zendy Tools annual

Global: Zendy Tools monthly

Global: Zendy Free Plan

We propose a two-stage design for a clinical trial with an early stoppingrule for safety. We use different criteria to assess early stopping andefficacy. The early stopping rule is based on a criteria that can be determinedmore quickly than that of efficacy. These separate criteria are also nested inthe sense that efficacy is a special case of, but not identical to, the earlystopping criteria. The design readily allows for planning in terms ofstatistical significance, power, and expected sample size necessary to assessan early stopping rule. This method is illustrated with a Phase II designcomparing patients treated for lung cancer with a novel drug combination tothose treated using historical control. In this example, the early stoppingrule is based on the numbers of patients who exhibit progression-free survival(PFS) at 2 months post treatment follow-up and efficacy is judged by the numberof patients who have PFS at 6 months.

A Two-Stage, Phase II Clinical Trial Design with Nested Criteria for Early Stopping and Efficacy