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, 3 (11), e002957

Factors Influencing Clinical Trial Site Selection in Europe: The Survey of Attitudes Towards Trial Sites in Europe (The SAT-EU Study)

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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)

Marta Gehring et al. BMJ Open.

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.

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.

Keywords: Clinical trial site selection criteria; European clinical trial competitiveness.

Figures

Figure 1
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.
Figure 2
Figure 2
Respondent's organisation. Respondents were asked to answer the question: “Please indicate which organisation most closely resembles yours.” Bars show percentage distribution of 485 individual responses. Biotech, biotechnology companies; CRO, clinical research organisation; CTU, clinical trial unit; medical devices, radiological, electromedical or healthcare information technology; pharma, pharmaceutical companies; other included following self-reported categories: respondent working for a mixed portfolio industry with either pharma/biotech portfolio or pharma/medical device portfolio (self reported); regulatory/clinical consultant, hospital or private clinic.
Figure 3
Figure 3
Left panel: respondent hierarchy. Respondents were asked to answer the question: “Please indicate the position which most closely resembles yours.” Chart shows percentage distribution of 485 individual responses. VP, Vice President. ‘Other’ were respondents who wanted to be more specific in their titles: global study manager/clinical research associate (CRA); regulatory affairs/regulatory in a clinical department/good clinical practice quality assurance manager or director/safety pharmacovigilance officer; medical affairs/medical director/clinical director/global scientific affairs; and general manager. Right panel: respondent organisation's decision-making process. Respondents were asked to answer the question: “Please indicate which most closely resembles how trial site selection decisions are made at your institution.” Chart shows percentage distribution of 485 individual responses. Other (11.8%) included: my staff decides; decision outsourced to CRO; clinical research associate decides; decisions according to standard operating procedures; many people involved in decision; study team decides; our affiliates decide.
Figure 4
Figure 4
Upper panel: accessibility and transparency of all types of information required to make trial site selection decisions—12 country rank (N=296). Respondents were asked to rate 12 countries for the accessibility and transparency of information (of all types) required to make trial site selection. Bars represent mean and 95% CI. Statistically significant difference in satisfaction across European Union (EU) countries (p=0.0001). Lower panel: predictability and speed of ethics committees and institutional review boards (IRBs) for phase II–III multicentre randomised controlled trials (RCTs)—12 country rank (N=296). Respondents were asked to rate 12 countries for the speed of their ethics committees and Institutional Review Boards for phase III (3) multicentric RCTs. Bars represent mean and 95% CI (number of respondents in parentheses). Statistically significant difference in satisfaction across EU countries (p=0.0001).
Figure 5
Figure 5
Trial site desirability by country. Trial site desirability ‘index’—nine country rank (N=296; ordered by median). Respondents were asked to provide their ‘personal perception’ ranking of the desirability of running trials in nine countries, ranking them from ‘1’ ‘most desirable’ country to ‘9’ ‘least desirable’ country (if needed, they could click ‘no opinion’ in up to three countries they know the least). Data are presented as whisker-box plot of median and lower and upper quartile. There was evidence of a statistically significant difference in the perceived desirability of running trials across European Union countries (p=0.0001).
Figure 6
Figure 6
Left panel: likelihood of selecting trial site given relevant information. Respondents were asked to rate their level of agreement with the statement: “I am much more likely to select a trial site if I have all of the relevant Investigator and Site specific information easily available to me.” Chart represents percentage response (N=253). Right panel: usefulness of trial site website information. Respondents were asked to pick the statement that they felt closest to with reference to the assertion that “it would be useful to have relevant trial information readily visible in a dedicated public section the Hospital's website (facilities, equipment, personnel qualification, Ethics Committee and Institutional Review Board timings, contact people for trials, etc).”

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