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Factors Influencing Clinical Trial Site Selection in Europe

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Factors Influencing Clinical Trial Site Selection in Europe BMJ Open: first published as 10.1136/bmjopen-2013-002957 on 15 November 2013. Downloaded from Open Access Research Factors influencing clinical trial site selection in Europe: the Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study) Marta Gehring,1 Rod S Taylor,2 Marie Mellody,3 Brigitte Casteels,4 Angela Piazzi,3 Gianfranco Gensini,5 Giuseppe Ambrosio6 To cite: Gehring M, ABSTRACT et al Strengths and limitations of this study Taylor RS, Mellody M, . Objectives: Applications to run clinical trials in Factors influencing clinical Europe fell 25% between 2007 and 2011. Costs, speed ▪ trial site selection in Europe: We provide systematic evidence across a large of approvals and shortcomings of European Clinical the Survey of Attitudes sample of expert professionals indicating that towards Trial sites in Europe Trial Directive are commonly invoked to explain this fostering competitiveness of European clinical (the SAT-EU Study). BMJ unsatisfactory performance. However, no hard evidence research may not require additional government Open 2013;3:e002957. is available on the actual weight of these factors or has spending/incentives. Carefully crafted harmonisa- doi:10.1136/bmjopen-2013- it been previously investigated whether other criteria tion of approvals, greater visibility of centres of 002957 may also impact clinical trial site selection. excellence via disease networks/the web, and Design: The Survey of Attitudes towards Trial sites in reduction of ‘hidden’ costs are more likely to ▸ Prepublication history for Europe (SAT-EU Study) was an anonymous, cross- boost competitiveness of European clinical this paper is available online. sectional web-based survey that systematically research. To view these files please assessed factors impacting European clinical trial site ▪ Consistent with voluntary surveys, we could only visit the journal online selection. It explored 19 factors across investigator- analyse responses provided by those interested (http://dx.doi.org/10.1136/ driven, hospital-driven and environment-driven criteria, in replying, and therefore cannot exclude that bmjopen-2013-002957). and costs. It also surveyed perceptions of the other points of view may have emerged from European trial environment. Received 1 April 2013 those who did not participate; our questionnaire Revised 9 October 2013 Setting and participants: Clinical research may also have missed potentially important http://bmjopen.bmj.com/ Accepted 10 October 2013 organisations (CROs), academic clinical trial units factors. (CTUs) and industry invited to respond. ▪ Carefully crafted harmonisation of approvals, Outcome measures: Primary outcome: weight greater visibility of centres of excellence via assigned to each factor hypothesised to impact trial disease networks/the web, and reduction in site selection and trial incidence. Secondary outcome: ‘hidden’ costs are more likely to boost the com- desirability of European countries to run clinical trials. petitiveness of European clinical research. Results: Responses were obtained from 485 professionals in 34 countries: 49% from BioPharma, 1 ‘ ’ on September 25, 2021 by guest. Protected copyright. sbg Healthcare Consulting, 40% from CTUs or CROs. Investigator-dependent, of centres of excellence and reduction of hidden Lausanne, Switzerland environment-dependent and hospital-dependent factors indirect costs, may bring significantly more clinical 2 Exeter Medical School, were rated highly important, costs being less important trials to Europe. Institute of Health Services (p<0.0001). Within environment-driven criteria, pool of Research, University of eligible patients, speed of approvals and presence of Exeter, UK disease-management networks were significantly more 3Virtuoso Consulting, Geneva, Switzerland important than costs or government financial 4BC Consulting & Solutions, incentives (p<0.0001). The pattern of response was INTRODUCTION Lausanne, Switzerland consistent across respondent groupings (CTU vs CRO Europe has consistently expressed a desire to 5 Division of Cardiology, vs industry). Considerable variability was demonstrated maintain and improve clinical trial competi- University of Florence, in the perceived receptivity of countries to undertake – tiveness,1 3 most recently by advocating a Florence, Italy clinical trials, with Germany, the UK and the 6 ‘ ’ Division of Cardiology, European Research Area in which Netherlands rated the best trial markets (p<0.0001). ‘ fi University of Perugia School Conclusions: Investigator-dependent factors and ease researchers, scienti c knowledge and tech- of Medicine, Perugia, Italy ’ 4 of approval dominate trial site selection, while costs nology circulate freely . A major component of the European governance for clinical Correspondence to appear less important. Fostering competitiveness of Dr Giuseppe Ambrosio; European clinical research may not require additional research, European Clinical Trial Directive giuseppe.ambrosio@ government spending/incentives. Rather, 2001/20/EC (CTD) was intended to support ospedale.perugia.it harmonisation of approval processes, greater visibility this goal, focusing on the harmonisation of Gehring M, Taylor RS, Mellody M, et al. BMJ Open 2013;3:e002957. doi:10.1136/bmjopen-2013-002957 1 BMJ Open: first published as 10.1136/bmjopen-2013-002957 on 15 November 2013. Downloaded from Open Access – research processes across EU member states.5 9 However, academic and commercial sponsors. Finally, the survey the CTD failed to achieve its intended impact on the sought to explore perceptions of the current European simplification and harmonisation of administrative provi- trial environment, and to identify areas for future sions governing clinical trials,9 and thus on the level of improvement. European clinical research activity.21011In fact, from 2007 to 2011, the number of clinical trial applications in Europe fell 25%.12 Accordingly, although concerted METHODS calls for further CTD revisions continue13 14 and recom- Survey design mendations awaiting member state review have been The SAT-EU Study was an anonymous web-based cross- made by the European Commission6 and endorsed by sectional survey undertaken between 26 September 2011 scientific societies,15 it is not clear which specific recom- and 21 January 2012. It included all stakeholder groups mendations should be implemented or prioritised at involved in clinical trial site selection, that is, BioPharma either national or pan-European level. companies, medical device manufacturers, CROs and Much of this uncertainty stems from an insufficient CTUs. The survey sought to capture information on understanding of the key drivers determining decision early-phase and late-phase studies. Late-phase studies made by the healthcare industry, academic clinical trial were defined as phase III for CTUs, BioPharma and units (CTUs) and clinical research organisations their subcontractors (ie, CROs) and phase IV for other (CROs) in selecting European trial sites. Furthermore, participants (eg, medical device companies). although it is widely believed that costs and speed of A multistage approach was used to develop the survey. approval are key factors influencing clinical trial inci- First, we identified the main criteria expected to impact dence in Europe,616the relative weight of these and site selection. Second, we organised these into four other important criteria is poorly understood. To our broad categories: (1) investigator related, (2) hospital/ knowledge, no published studies have examined country institution related, (3) country/environment related and and site selection criteria for trials conducted in Europe. (4) costs (evaluated separately and within the environ- Evidence is therefore needed to improve our under- ment category). Third, the defined criteria underwent standing of stakeholders’ decision-making process. review and discussion with a small number of knowl- The Survey of Attitudes towards Trial sites in Europe edgeable professionals to ensure that potentially relevant (the SAT-EU Study) was established as a non-profit col- criteria had not been missed (figure 1). laborative effort to systematically assess factors impacting The study group then built an internet-based survey clinical trial site selection in Europe. We also investi- hosted on a freely accessible online questionnaire soft- gated whether trial selection needs differ between ware (Survey Monkey, Palo Alto, California, USA). http://bmjopen.bmj.com/ on September 25, 2021 by guest. Protected copyright. Figure 1 Hypothesis about trial site selection criteria. Four categories of levers potentially impacting trial site selection were identified. Survey-weighed relevance across these four levers, then drilled down for weight within each subcategory. 2 Gehring M, Taylor RS, Mellody M, et al. BMJ Open 2013;3:e002957. doi:10.1136/bmjopen-2013-002957 BMJ Open: first published as 10.1136/bmjopen-2013-002957 on 15 November 2013. Downloaded from Open Access Before launching the survey, healthcare market research Respondent demographics experts (The Planning Shop International, London, Respondents represented over 37 countries, the top five UK) reviewed the survey design to optimise content and contributors being Italy, USA, the UK, Germany and minimise bias. Additionally, a pilot survey undertaken by Spain (table 1). Participants were almost evenly split 15 respondents in June 2011 was used to validate and between BioPharma (49%) and CROs/CTUs (40%; refine question content and organisation. figure 2). In terms of hierarchy/job
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