Factors influencing clinical trial site selection in Europe: The Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study)

Marta Gehring, Rod S. Taylor, Marie Mellody, Brigitte Casteels, Angela Piazzi, Gianfranco Gensini, Giuseppe Ambrosio

Research output: Contribution to journalArticle

Abstract

Objectives: Applications to run clinical trials in Europe fell 25% between 2007 and 2011. Costs, speed of approvals and shortcomings of European Clinical Trial Directive are commonly invoked to explain this unsatisfactory performance. However, no hard evidence is available on the actual weight of these factors or has it been previously investigated whether other criteria may also impact clinical trial site selection. Design: The Survey of Attitudes towards Trial sites in Europe (SAT-EU Study) was an anonymous, crosssectional web-based survey that systematically assessed factors impacting European clinical trial site selection. It explored 19 factors across investigatordriven, hospital-driven and environment-driven criteria, and costs. It also surveyed perceptions of the European trial environment. Setting and participants: Clinical research organisations (CROs), academic clinical trial units (CTUs) and industry invited to respond. Outcome measures: Primary outcome: weight assigned to each factor hypothesised to impact trial site selection and trial incidence. Secondary outcome: desirability of European countries to run clinical trials. Results: Responses were obtained from 485 professionals in 34 countries: 49% from BioPharma, 40% from CTUs or CROs. Investigator-dependent, environment-dependent and hospital-dependent factors were rated highly important, costs being less important (p

Original languageEnglish
Article number19
JournalBMJ Open
Volume3
Issue number11
DOIs
Publication statusPublished - 2013

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ASJC Scopus subject areas

  • Medicine(all)

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