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Journal of Long-Term Effects of Medical Implants

Erscheint 4 Ausgaben pro Jahr

ISSN Druckformat: 1050-6934

ISSN Online: 1940-4379

SJR: 0.184 SNIP: 0.485 CiteScore™:: 1.1 H-Index: 39

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Challenges in Conducting Multicenter, Multicultural, and Multilingual Trials: A View from the Literature and Real-Life Experience Reports

Volumen 23, Ausgabe 2-03, 2013, pp. 241-254
DOI: 10.1615/JLongTermEffMedImplants.2013010014
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ABSTRAKT

A trend toward international multicenter clinical trials in the medical device industry is helping to increase recruitment figures and to improve the generalizability of results, among other factors. However, working globally creates its own unique set of problems, which are rarely discussed in the literature. This article considers these issues from multicenter, multicultural, and multilingual perspectives. A multicenter study implies a replication of work to coordinate research sites that are working under different regulations. Standardizing elements of the clinical trial is essential for proper comparison of results. Multicultural differences manifest themselves in different forms in international clinical research. However, the impact of culture on a study's success is a real issue, particularly when patient-reported outcomes form part of the trial. A trial that is conducted globally obviously requires the use of local language material, but this element is fraught with the possibility of mistranslation and misunderstanding. In this article, we also examine the composition of a research team and how to keep everyone involved in a global clinical trial both informed and enthused about a trial that may last several years. Examples from our own clinical investigations are reported throughout this article.

REFERENZIERT VON
  1. De Faoite Diarmuid, The advantages of electronic patient-reported measures and an example digital platform to collect ePROs after total knee arthroplasty, Medicine Access @ Point of Care, 2, 2018. Crossref

  2. Meyerheim Marcel, Burns-Gebhart Anna, Mirzaie Kasra, Garani-Papadatos Tina, Braun Yvonne, Graf Norbert, Challenges and Pitfalls for Implementing Digital Health Solutions in Clinical Studies in Europe, Frontiers in Digital Health, 3, 2021. Crossref

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