Dear CDISC Community,
CDISC is pleased to announce the draft v1.0 of the ADaMIG for Anti-Drug Antibody Data is entering the Public Review period to solicit your feedback.
An anti-drug antibody (ADA) is generated as an immune response to a drug (generally a biologic therapeutic). ADA data analysis is also referred to as "immunogenicity analysis." ADA analysis includes a summary of ADA incidence and magnitude (results from an ADA assay). When combined with additional relevant data, ADA may be used for analyzing clinical impact on pharmacokinetics (PK), pharmacodynamics (PD), and efficacy and safety. The purpose of this document is to provide guidance and examples for creating analysis datasets for ADA data.
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View the draft: ADaMIG Anti-Drug Antibody Data v1.
Instructions for providing comments: Instructions for Reviewers
Public Review closes 15 June 2026.
Public review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.
Thank you for contributing your time and expertise.