Publications by authors named "M P Backer"
Neutralizing antibody titer has been a surrogate endpoint for guiding COVID-19 vaccine approval and use, although the pandemic's evolution and the introduction of variant-adapted vaccine boosters raise questions as to this surrogate's contemporary performance. For 985 recipients of an mRNA second bivalent or monovalent booster containing various Spike inserts [Prototype (Ancestral), Beta, Delta, and/or Omicron BA.1 or BA.
View Article and Find Full Text PDFFrom Non-Inferiority to Superiority: The Shift Toward Patient-Centric Outcomes.
Eur Heart J Acute Cardiovasc Care
January 2025
Purpose: Oral mucositis (OM) is a debilitating side effect of cisplatin and intensity-modulated radiation therapy (IMRT) in patients with head and neck cancer. The phase 3 ROMAN trial showed avasopasem manganese (AVA) significantly decreased individual endpoints of incidence and duration of severe oral mucositis (SOM, World Health Organization [WHO] grade 3-4), with nominal decrease in severity (WHO grade 4) and significant increase in the delay in onset of SOM. We sought to determine the Net Treatment Benefit (NTB) of AVA versus placebo (PBO) using the generalized pairwise comparisons (GPC) method.
View Article and Find Full Text PDFArticle Synopsis
- Current treatment options are limited by the expectation that alternative therapies must be proven "non-inferior" to existing ones, making trials expensive and complex.
- Non-inferiority trials often overlook important factors like variability in treatment outcomes and place excessive burdens of proof on alternatives, especially in terms of toxicity and cost.
- The authors suggest moving away from labeling trials as superiority or non-inferiority, advocating instead for a simpler description of trials as "comparative" to promote better patient-centered treatment options.