1887
Volume 8, Issue 2
  • ISSN 2032-6904
  • E-ISSN: 2032-6912
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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.

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2022-03-28
2022-05-23
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References

  1. Claudot, Frédérique, François Alla, Jeanne Fresson, Thierry Calvez, Henry Coudane, Catherine Bonaïti-Pellié
    2009 “Ethics and observational studies in medical research: various rules in a common framework.” International Journal of Epidemiology38 (4): 1104–1108. AccessedApril 2021.   10.1093/ije/dyp164
    https://doi.org/10.1093/ije/dyp164 [Google Scholar]
  2. Collier, Roger
    2014 “The art and science of naming drugs.” Canadian Medical Association Journal186 (14): 1053. AccessedApril 2021.   10.1503/cmaj.109‑4864
    https://doi.org/10.1503/cmaj.109-4864 [Google Scholar]
  3. DLA Piper
    DLA Piper 2021Data Protection Laws of the World. AccessedApril 10, 2021. https://www.dlapiperdataprotection.com/
    [Google Scholar]
  4. FDA
    FDA 2018 “Framework for FDA’s real-world evidence program.” US, December. AccessedApril 24, 2021. https://www.fda.gov/media/120060/download
  5. FDA
    FDA 2006 “Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.” Health Quality of Life Outcomes – Journal4 (79). AccessedMay 10, 2021.   10.1186/1477‑7525‑4‑79
    https://doi.org/10.1186/1477-7525-4-79 [Google Scholar]
  6. FDA
    FDA 2020Real World Evidence. 30 11. AccessedMarch 02, 2021. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
    [Google Scholar]
  7. Federici, Eleonora
    2013Bridging the Gap Between Theory and Practice in Translation and Gender Studies. Newcastle: Cambridge Scholars Publisher.
    [Google Scholar]
  8. Folaron, Debbie
    2006Perspectives on Localization. Edited byKeiran J. Dunne. Netherlands: J. Benjamins Publishing Company. AccessedOctober 18, 2021. 10.1075/ata.xiii
    https://doi.org/10.1075/ata.xiii [Google Scholar]
  9. GDPR
    GDPR 2016 2016/679 (European Union, https://gdpr.eu/). AccessedApril 28, 2021. https://gdpr.eu/
  10. Gianfranco De Feo, Giacomo Chiabrando, Nunzia Cannovo, Antonio Galluccio, Carlo Tomino
    2012 “Harmonization of the Practice of Independent Ethics Committees in Italy: Project E-Submission.” Edited byBarbara Ensoli. PLOS ONE – Journal7 (11). AccessedOctober 18, 2021.   10.1371/journal.pone.0048906
    https://doi.org/10.1371/journal.pone.0048906 [Google Scholar]
  11. James, K. L.
    2008 “Software Engineering.” InSoftware Engineering, byK. L. James, 231–233. PHI Learning.
    [Google Scholar]
  12. Karet, Gail B.
    2019 “How do drugs get named?” AMA Journal of Ethics21 (8): 686–696. AccessedApril 2021.   10.1001/amajethics.2019.686
    https://doi.org/10.1001/amajethics.2019.686 [Google Scholar]
  13. Lange, D. W., Bertrand Guidet, Finn H. Andersen, Antonio Artigas, Guidio Bertolini, Rui Moreno, Steffen Christensen, Maurizio Cecconi, Christina Agvald-Ohman, Primoz Gradisek, Christian Jung, Brian J. Marsh, Sandra Oeyen, Bernardo Bollen Pinto, Wojci
    2019 “Huge variation in obtaining ethical permission for a non-interventional observational study in Europe.” BMC Medical Ethics – Journal20 (39). AccessedApril 2021.   10.1186/s12910‑019‑0373‑y
    https://doi.org/10.1186/s12910-019-0373-y [Google Scholar]
  14. Lemaire, Francois
    2006 “Do All Types of Human Research Need Ethics Committee Approval?” American Journal of Respiratory and Critical Care Medicine174 (4): 363–366. AccessedMarch 2021.   10.1164/rccm.2603003
    https://doi.org/10.1164/rccm.2603003 [Google Scholar]
  15. Makoto Kaneko, Masato Matsushima
    2017 “Current trends in Japanese health care: establishing a system for board-certified GPs.” British Journal of General Practice67 (654): 29. AccessedAugust 10, 2021.   10.3399/bjgp17X688669
    https://doi.org/10.3399/bjgp17X688669 [Google Scholar]
  16. Microsoft
    Microsoft 2021Microsoft Language Portal. 01March. AccessedMarch 03, 2021. https://www.microsoft.com/en-us/language/Search
    [Google Scholar]
  17. Munday, Jeremy
    2016Introducing Translation Studies: theories and applications (4th ed.). London/New York: Routledge. AccessedOctober 18, 2021. 10.4324/9781315691862
    https://doi.org/10.4324/9781315691862 [Google Scholar]
  18. Nadina Iacob, Felice Simonelli
    2020 “Towards a European Health Data Ecosystem.” European Journal of Risk Regulation11 (4): 884–893. AccessedSeptember 1, 2021.   10.1017/err.2020.88
    https://doi.org/10.1017/err.2020.88 [Google Scholar]
  19. NHS
    NHS 2021HRA Tool. AccessedFebruary 14, 2021. www.hra-decisiontools.org.uk/ethics/
    [Google Scholar]
  20. Perlman, Max
    2000 “Ethical issues in ’observational research’.” Pediatric Child Health – Journal (Pediatric Child Health) 5 (2): 89–90. AccessedMarch 2021.   10.1093/pch/5.2.89
    https://doi.org/10.1093/pch/5.2.89 [Google Scholar]
  21. R. Hernandez, M. Cooney, C. Dualé, M. Gálvez, S. Gaynor, G. Kardos, C. Kubiak, S. Mihaylov, J. Pleiner, G. Ruberto, N. Sanz, M. Skoog, P. Souri, C. O. Stiller, A. Strenge-Hesse, A. Vas, D. Winter and X. Carné
    2009 “Harmonisation of ethics committees’ practice in 10 European countries.” Journal of Medical Ethics35 (11): 696–700. AccessedOctober 18, 2021. https://www.jstor.org/stable/20696679. 10.1136/jme.2009.030551
    https://doi.org/10.1136/jme.2009.030551 [Google Scholar]
  22. Richards, A., King, K.
    2017 “The risks in translating smartphone strings for medical study smartphone app and smartwatches.” Value in Health – Journal20 (9): PRM189. AccessedMarch 2021. https://www.valueinhealthjournal.com/article/S1098-3015(17)32507-X/fulltext#relatedArticles. 10.1016/j.jval.2017.08.2173
    https://doi.org/10.1016/j.jval.2017.08.2173 [Google Scholar]
  23. Simon, Patrick
    2015The Choice of Ignorance: The Debate on Ethnic and Racial Statistics in France. Springer, Cham. AccessedOctober 18, 2021.   10.1007/978‑3‑319‑20095‑8_4
    https://doi.org/10.1007/978-3-319-20095-8_4 [Google Scholar]
  24. Timo Minssen, Neethu Rajam, Marcel Bogers
    2020 “Clinical trial data transparency and GDPR compliance: Implications for data sharing and open innovation.” Science and Public Policy – Journal47 (5): 616–626.   10.1093/scipol/scaa014
    https://doi.org/10.1093/scipol/scaa014 [Google Scholar]
  25. Torjesen, Ingrid
    2015 “Drug development: the journey of a medicine from lab to shelf.” The Pharmaceutical Journal. AccessedMarch 2021.   10.1211/PJ.2015.20068196
    https://doi.org/10.1211/PJ.2015.20068196 [Google Scholar]
  26. Tyupa, Sergiy, and Diane Wild
    2016 “Translating Clinical Trial Outcomes Measures. An Overview.” InTranslating Clinical Trial Outcomes Measures. An Overview, bySergiy Tyupa and Diane Wild, 83. SEEd.
    [Google Scholar]
  27. W3C
    W3C 2021 “Making the Web Accessible.” World Wide Web Consortium. 01January. Accessed04 February, 2021. https://www.w3.org/TR/wcag-3.0/
    [Google Scholar]
  28. WHO
    WHO 2011Standards and operational guidance for ethics review of health-related research with human participants. World Health Organization. AccessedFeburary 2021. https://www.who.int/publications/i/item/9789241502948
    [Google Scholar]
  29. Wild, D., Grove, A., Martin, M.,
    2005 “Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation.” Value in Health – Journal8 (2): 94–104. AccessedMarch 2021. https://pubmed.ncbi.nlm.nih.gov/15804318/. 10.1111/j.1524‑4733.2005.04054.x
    https://doi.org/10.1111/j.1524-4733.2005.04054.x [Google Scholar]
  30. Will, Anne-Kathrin
    2019 “The German statistical category “migration background”: Historical roots, revisions and shortcomings.” Ethnicities535–557. AccessedOctober 18, 2021.   10.1177/1468796819833437
    https://doi.org/10.1177/1468796819833437 [Google Scholar]
  31. WMA
    WMA 2013Declaration of Helsinki. Declaration, Helsinki: World Medical Association. AccessedMarch 2021. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
    [Google Scholar]
  32. World Wide Web Consortium
    World Wide Web Consortium 2018https://www.w3.org/. 05June. AccessedApril 28, 2021. https://www.w3.org/TR/WCAG21/
    [Google Scholar]
  33. Yunker, John
    2003 “Text Expansion and contraction.” InBeyonds Borders, Web Globalization Strategies. Indianapolis: New Riders.
    [Google Scholar]
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