Localization of clinical research

Abstract

Abstract Clinical research using human participants to further medical knowledge has been at the forefront in 2021. Clinical research studying the efficacy of treatments can be categorised in two broad categories as ‘observational studies’ or ‘clinical trials’. Written from the perspective of a localization project manager at Vitaccess, which conducts global digital research for biopharmaceutical companies, this paper discusses five core challenges that impact the localization of such a study launched in France, Italy, Germany, Belgium, Spain, Japan, the UK, the US and Canada, conducted via a smartphone app. The localization project manager role provides a bridge between translators, revisers, ethics bodies, authors, legal, and medical reviewers, enabling oversight to keep the balance between launching the study globally and enabling each country to have the content and structure tailored to their cultural and linguistic expectations through localization. The main challenges in localizing a real-world evidence study is the complexity and volume of ethical, legal, and medical feedback required for the content of the study, which is further complicated by the need to target different countries and languages. Subjectivity and variance in the feedback per country also pose difficulties. International harmonisation of ethical, medical, and legal reviews of such global studies could streamline the process.