Evaluation of in-study cut points to enable appropriate interpretation of clinical immunogenicity results

Due to the sequential nature of drug development and the need to assess the ADA potential for a given protein therapeutic in various development phases, cut points should be evaluated at various times during method development and clinical studies: at minimum at method validation, in early phase clinical studies, in late phase clinical studies and in studies of different disease indications. Evaluating in-study cut points should be considered as part of an ADA method development and sample analysis strategy. As demonstrated in the two examples, the decision of adapting in-study cut points was situational. When in-study cut points are evaluated and eventually utilized for study sample analysis, relevant information should be recorded in official documents, such as the sample bioanalytical plan and report. The documents should include a pre-defined strategy on selecting in-study cut points so that reviewers are informed of the rationales for the choice and avoid confusion. © 2019 © 2019 Newlands Press.