Localization of clinical research
Challenges facing global health research
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.
Article outline
- 1.Introduction to real-world evidence
- 2.App localization and user feedback
- 3.Ethics review
- 4.Legal feedback
- 5.Medical feedback
- 6.Patient reported outcome measure (PROM) legacy and patient feedback
- 7.Conclusion
- Notes
-
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