Application of Pharmacogenomics in Global Alzheimer’s Disease Clinical Trials and Ethical Implications

摘要: Decades ago, pharmacogenetic research established that one’s genetic profile might predict efficacy and safety of medicines. Polymorphic expression isoenzymes the cytochrome P-450 enzyme system explains a significant amount variability inter-individual responses to In Alzheimer’s disease, highly variable clinical response cholinesterase inhibitors metabolized by liver is explained on this basis. More recently, translation basic pharmacogenomic through drug development process has led approval ”personalized“ medicines, for example, in field oncology, cardiology psychiatry, based an individual’s underlying genotypic variance phenotypically expressed pathogenic targets pathways. Translational disease emerged as viable alternative study large populations with similar phenotypic symptoms stratification sub-groups ApoE carrier status trials. When initiating global protocol, it incumbent upon sponsors actively engage stakeholders developing underdeveloped countries, including local government authorities, regulatory bodies, ethics review boards, community representatives participants, address all aspects trial, especially informed consent, which may be more challenging countries where customs practices dictate need innovative approaches. Implementation pharmacogenomics trial requires further attention ethical detail related what kind consent needed use stored DNA samples future, unforeseen or unrelated research, whether whom disclose current future results, ways benefits discoveries are shared developed countries.