To propose, through a comprehensive systematic review, the "E-DSP" (Evidence-Based Drug Safety Profile) model— a systematic, evidence-based methodology for synthesizing safety data on a class of drugs or a specific drug by extracting data from the scientific literature and international ICSR databases. The example of ADCs (Antibody-Drug Conjugates) used in the treatment of breast cancer will be utilized. This review is proposed as a systematic method for synthesizing and presenting safety data for a drug or drug class in a uniform manner, and thus seeks to standardize thepresentation of: 1) disproportionality analyses; 2) data extracted from the scientific literature on adverse drug reactions; 3) prompt clinical management of specific ADRs or symptoms suggestive of them.
Baldo et al. (Thu,) studied this question.