Background: Pivotal evidence of efficacy of a new drug is typically generated by (at least)
two clinical trials which independently provide statistically significant and mutually …

Modern data analysis frequently involves large-scale hypothesis testing, which naturally
gives rise to the problem of maintaining control of a suitable type I error rate, such as the …

The use of decision trees and artificial neural networks (ANNs) in health-care research is
widespread, as they enable health-care providers with the tools they need to make better …

Two pivotal, randomized, double-blind studies in a chronic dermatology disease were
ongoing when the COVID-19 pandemic broke out. The trials had identical design, with four …

Replicability of results is regarded as the corner stone of science. Recent research seems to
raise doubts about whether this requirement is generally fulfilled. Often, replicability of …

Graphical approaches allow one to map the relative importance of different objectives as
well as their relation onto an appropriately tailored multiple comparison procedure. They …

We thank Dr. LaVange for the insightful overview of her tenure at the United States Food and
Drug Administration (FDA). We enjoyed the broad discussion of statistical topics arising from …

This comment focuses on Section 50.1, provisions 1 & 3 of the draft guidance regarding the
negotiation of a “maximum fair price” under the Inflation Reduction Act (IRA), research and …

The current proposal is a mixed method of research, comparing the efficacy of designed
experiments and one-factor-at-a-time (OFAT) experiments in drug development within the …

We are grateful for the opportunity to enjoy reading the article by Dr. Eric Gibson (Gibson
2020). The article covers a lot of important subjects concerning strength of evidence very …