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Factors influencing clinical trial site selection in Europe: the Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study)
  1. Marta Gehring1,
  2. Rod S Taylor2,
  3. Marie Mellody3,
  4. Brigitte Casteels4,
  5. Angela Piazzi3,
  6. Gianfranco Gensini5,
  7. Giuseppe Ambrosio6
  1. 1sbg Healthcare Consulting, Lausanne, Switzerland
  2. 2Exeter Medical School, Institute of Health Services Research, University of Exeter, UK
  3. 3Virtuoso Consulting, Geneva, Switzerland
  4. 4BC Consulting & Solutions, Lausanne, Switzerland
  5. 5Division of Cardiology, University of Florence, Florence, Italy
  6. 6Division of Cardiology, University of Perugia School of Medicine, Perugia, Italy
  1. Correspondence to Dr Giuseppe Ambrosio; giuseppe.ambrosio{at}ospedale.perugia.it

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, cross-sectional web-based survey that systematically assessed factors impacting European clinical trial site selection. It explored 19 factors across investigator-driven, 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<0.0001). Within environment-driven criteria, pool of eligible patients, speed of approvals and presence of disease-management networks were significantly more important than costs or government financial incentives (p<0.0001). The pattern of response was consistent across respondent groupings (CTU vs CRO vs industry). Considerable variability was demonstrated in the perceived receptivity of countries to undertake clinical trials, with Germany, the UK and the Netherlands rated the best trial markets (p<0.0001).

Conclusions Investigator-dependent factors and ease of approval dominate trial site selection, while costs appear less important. Fostering competitiveness of European clinical research may not require additional government spending/incentives. Rather, harmonisation of approval processes, greater visibility of centres of excellence and reduction of ‘hidden’ indirect costs, may bring significantly more clinical trials to Europe.

  • European clinical trial competitiveness
  • Clinical trial site selection criteria

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

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