Comment from Merck &Co., Inc., Rahway, NJ, USA
AnonymousOtherIndividual
Summary: The commenter is seeking technical guidance and suggestions on aligning the proposed guidance with existing CDISC standards (specifically the ADADA dataset). They are asking for clarification on dataset naming and variable recommendations compared to current industry practices.
This comment is about "Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug; Guidance for Industry". There is a CDISC sub team who drafted the ADaM dataset for Anti-drug Antibody data which has the similar concept to put the immunogenicity data in a subclass "ADADA" of the BDS class. The draft IG just ended with public review. any suggestions to follow ADADA IG. The big difference is 1. dataset name ADADA vs. ADIS. 2. AVALC2 was recommended, and ADASUBJ by this guidance, while ADADA may allow more scenarios for domain level immunogenicity response data, and more options for subject level conclusion: ADA onset, duration, persistent/transient, etc. . Any suggestions?