Immunogenicity Publication Bias and Its Consequences for Predictive Models: A Call for Transparent Reporting
Abstract
Understanding immunogenicity is crucial to improving therapeutic protein development. By comparing Phase I to III antidrug antibody (ADA) incidence data of Roche-internal and approved monoclonal antibodies, we demonstrate a bias toward lower ADA incidence in published data, partly because ADA data from early trials-often discontinued for reasons related to high immunogenicity-are rarely published. Through an empirical model, we show how this bias affects ADA incidence time-course predictions, underscoring the need for cross-industry transparent data reporting.
Fields of Study & Subjects
Biosimilars and Bioanalytical Methods
Monoclonal and Polyclonal Antibodies Research
Statistical Methods in Clinical Trials
Publication details
- Journal / source
- CPT Pharmacometrics & Systems Pharmacology
- Volume
- 15
- Issue
- 2
- Pages
- e70184–e70184
- Publication date
- 28 January 2026
- Language
- EN