Establishment of Real World Research Model for Multinational Pharmacoepidemiologic Study - the Antipsychotics Use in Children, Adolescents, and Young Adult.

Project: Research project

Project Details

Description

BACKGROUND Multinational pharmacoepidemiologic studies (MPES) provide opportunities to promote research capability on effectiveness and risk of drug use by health data from various countries as well as collaboration. With advances in technology and informatics methods, studies using multiple databases covering a large number of patients across multiple countries have become more feasible. Because of concerns about data privacy and related ethical issues, a distributed network approach employing a common data model (CDM) is preferred in recent decades. Each data site converts domestic databases to a common data format and performs analyses by executing common analytic programs created by a coordinating center. This approach is optimal for producing high-quality, flexible, efficient analyses while preserving data privacy. However, converting databases from Asian countries can be more challenging than converting databases among North America and Europe, because of greater differences across health care systems, cultures, and languages. Therefore, establishment of an optimal research model for MPES feasible for Asian databases situation is required. OBJECTIVE To establish a research model for multinational pharmacoepidemiologic studies by distributed network approach employing a common data model and to evaluate the safety of antipsychotics in children, adolescents and young adults. METHOD We include databases from Taiwan, Korea, Hong Kong, Australia, Denmark and the United States in this three-year project. We convert the domestic databases to CDMs step by step from a simple version to a complex version. Use antipsychotics in pediatrics as example, we perform three analyses from a simple design with sequence symmetry analysis, self-controlled case series, and to a complex design with cohort study to validate the conversions of corresponding three versions of CDM, and to establish a recommendation guideline for MPES according to the collaboration experiences. SIGNIFICANCE This three-year project enable to establish a better environment for MPES and to facilitate the prompt identification and validation of safety issues especially among the Asian countries. Additionally, it develops updated real world evidences on the safety of antipsychotics in children, adolescents, and young adults for promoting decision making in therapeutic risk management. The project provides opportunities to enhance the collaborations and communications among researchers across countries and can gain a better understanding of the health systems and cultural factors that influence the use of medications.
StatusFinished
Effective start/end date18-01-0118-10-31