Criteria for site selection in industry-sponsored clinical trials: a survey among decision-makers in biopharmaceutical companies and clinical research organizations

Abstract

BackgroundKnowledge of what the pharmaceutical industry emphasizes when assessing trial sites during site selection is sparse. A better understanding of this issue can improve the collaboration on clinical trials and increase knowledge of how to attract and retain industry-sponsored trials. Accordingly, we investigated which site-related qualities multinational biopharmaceutical companies and clinical research organizations (CROs) find most important during site selection.MethodsAn online survey among decision-makers for trial site selection in the Nordic countries employed at multinational biopharmaceutical companies and CROs was conducted. The respondents’ experiences with and perceptions of site selection were addressed to evaluate the relative importance of site-related qualities. We included up to four respondents per company, representing different geographic regions. Descriptive statistics were used to summarize findings.ResultsOf 49 eligible companies, 20 biopharmaceutical companies and 23 CROs participated. In total, 83 responses were analyzed (estimated response rate 78%). A relative importance of site-related qualities was identified: For example, 88% (binomial 95% confidence interval [CI] ±7%) preferred reaching enrollment goals at trial sites in their region 10% quicker rather than cutting the costs at all sites by 20%. Likewise, 42% (CI ±11%) of the respondents preferred that trial sites were best at having the first patients ready for inclusion right after site initiation visit compared to having good data entry, documentation, and reporting practice (25% [CI ±9%]), easily reachable site personnel and backup (23% [CI ±9%]), fast contractual procedure times (6% [CI ±5%]), a key opinion leader associated with the site (3% [CI ±4%]), and updated equipment and facilities (1% [CI ±2%]). In total, 75% [CI ±9%] agreed that their company would be interested in cooperating with an inexperienced trial site if the site had access to a large patient population and 52% [CI ±11%] had experienced that their company selected an inexperienced trial site in favor of an experienced site due to a higher level of interest and commitment.ConclusionsThis study indicates that recruitment-related factors are pivotal to the pharmaceutical industry when assessing trial sites during site selection. Data quality-related factors seem highly valued especially in early phase trials whereas costs and investigator’s publication track record are less important. Experience in conducting clinical trials is not imperative. However, this applies primarily to late phase trials.

Translational research: from basic research to regional biomedical entrepreneurship

“…Thus, the large number of participating sites could have attenuated the strength of the relationship between the CTSA and clinical trials. Second, clinical trial site selection is heavily influenced by diverse factors such as recruitment-related factors (Dombernowsky et al, 2019 ; Hurtado-Chong et al, 2017 ; Silva, 2018 ). As shown in Table 5 , the number of clinical trials is strongly associated with population density and income per capita.…”

Validation of Evidence-based Questionnaire for TCM Syndrome Differentiation of Heart Failure and Evaluation of Expert Consensus

“…These selected 661 samples were collected from 25 hospitals, covering the streams of western medicine, integrated medicine, and traditional Chinese medicine from different regions of China. Adopting this sampling methodology could ensure the reliability and generalizability of samples as hospitals with more recruitment tend to have more resources and motives for the study, along with better administration to yield higher data quality for better representation (18,19). The selection of the recruited hospitals minimized the variations of data collection in different hospitals.…”

Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries

“…Site qualities examined include availability of trial participants, timely patient recruitment, resources of the site, and site personnel’s interest and commitment. 6 Site’s access to patients, that is, the capability to identify and reach potential trial participants, is a key reason for failure or success in recruitment. 7 We investigate here how access to patients is evaluated during feasibility evaluations carried out by trial sponsors in the pharmaceutical industry, how electronic health records (EHRs) are used in this process, and in case they are not used, what are the reasons.…”