The MaxCombo Test Severely Violates the Type I Error Rate

To the Editor In their recent systematic review and meta-analysis in JAMA Oncology, Mukhopadhyay et al compare 3 statistical tests based on historic immuno-oncology trials with registrational intent. Unsurprisingly, they conclude that the so-called MaxCombo test has higher power to demonstrate a treatment difference. However, they misleadingly cite one of our articles, claiming that this test controls the type I error. On the contrary, our publications demonstrate that MaxCombo is not valid to show benefit of a candidate drug. A better alternative to the standard log-rank test is the modestly weighted test.

Leggi
Aprile 2023

THE PRECIOUS STUDY: A PROSPECTIVE, OBSERVATIONAL STUDY OF CD8+ BIOMARKER BASED PROGNOSTIC TEST IN NORTH AMERICAN IBD PATIENTS

The clinical course of IBD varies considerably among patients1. One barrier to personalized medicine in IBD is the lack of a reliable prognostic assay that can be used at diagnosis to guide effective therapy for each patient, to optimize clinical outcomes and minimize complications. To address this need, a whole-blood qPCR-based prognostic assay was developed to divide IBD patients into two subgroups2. This transcriptional signature yields CD8 T-cell exhaustion level data that correlated with disease outcomes among IBD patients in UK2.

Leggi
Marzo 2023

FDA Approves First Over-the-counter Combined COVID-19 and Flu Test

In late February, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization to an at-home diagnostic test that identifies SARS-CoV-2, the virus that causes COVID-19, as well as influenza strains A and B. The test detected 100% of negative and 88.3% of positive COVID-19 samples, 99.3% of negative and 90% of positive influenza A samples, and 99.9% of negative influenza B samples.

Leggi
Marzo 2023