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Ther Innov Regul Sci ; 50(4): 442-449, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30227020

RESUMO

BACKGROUND: With the pharmaceutical industry's increased attention on enhancing patient experiences during their participation in clinical trials, the use of mobile nurse (MN) services to support the conduct of clinical trial assessments in the home (or in alternative locations other than in investigational sites) has been gaining momentum. METHODS: Because no quantitative data capturing industry-wide practices are available, in July 2014, Tufts Center for the Study of Drug Development and Hoffman-La Roche conducted an online survey to gather data on the prevalence and utilization of MN services in clinical trials taking into account the following factors: industry perceptions of the business model, risks barriers to adoption, vendor landscape, cost, and prospects for future growth. A total of 113 respondents answered the survey, with 53 respondents answering all questions. RESULTS: The use of MN services in clinical trials is an established and growing business practice. Utilization of MN services has so far been most prevalent in North America, followed by Western Europe. Sponsor companies that have adopted this model have done so mainly to improve patient retention and protocol compliance, as well as improve access to rare patients. Most of the companies surveyed work directly with vendors specializing in home nurse services. Experience with vendors was considered favorable in most cases. CONCLUSIONS: Building effective partnerships with 1 to 2 vendors is considered a key factor for long-term success.

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