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

Abstract

Introduction: Feasibility evaluations are performed to create the best possible starting point for the set-up and execution of a clinical trial, and to identify any obstacles for successful trial conduct. New digital technologies can provide various types of data for use in feasibility evaluations. There is a need to identify and compare such data sources for trial site identification and for evaluating the sites’ patient recruitment potential. Especially, information is needed on the use of electronic health records. We investigated how different data sources are used by pharmaceutical companies operating in the Nordic countries for identifying trial sites and for evaluating their potential to recruit trial participants. Methods: This was a semi-structured qualitative interview study with 21 participants from pharmaceutical companies and contract research organizations operating in Finland, Sweden, Denmark and Norway. Qualitative content analysis was applied. Results: For identifying countries and trial sites on a global level, the trial sponsors mostly used databases on previous trial performance. The use of electronic health record data was very limited. Sites’ and investigators’ visibility in various databases was seen as fundamental for their countries becoming selected into new clinical trials. For estimating the sites’ recruitment projections, most sites were seen to base their patient count estimates solely on their previous experience. Some sites had reviewed their electronic health record data, which was considered to increase the accuracy of their recruitment estimates and these sites’ attractivity. Along with dialogs with investigators, the sponsors used various data sources to validate the investigators’ estimates. Legislative obstacles were seen to hinder the use of electronic health record queries for estimation of patient counts. Conclusion: Visibility in the databases used by trial sponsors is crucial for the countries and sites to be identified. Site selection appears to be based on trust and relationships built from experience, but electronic data provide the support upon which the trust is based. Estimation of the number of potential trial participants is a complex and time-consuming process for both investigators and sponsors. Sponsors seem to favour sites who could support their patient count estimates with electronic health record data as they were quicker in providing the estimates and more reliable than sites with no electronic health record evidence. The patient count evaluation process could be simplified, accelerated and made more reliable with more systematic use of electronic health record evidence in the feasibility evaluation phase. This would increase the accuracy of the patient count estimates and, on its part, contribute to improved recruitment success.

Enhancing site selection strategies in clinical trial recruitment using real-world data modeling

“…Past site & investigator trial performance. [3,[6][7][8][13][14][15][16] Past site & investigator trial experience. [3,[13][14][15]17] Study population, procedures and treatments performed at hospital.…”

“…Existing study-site models examine variables that describe a small number of site-specific factors such as research experience, but these modeling approaches and their data are not tailored to the study indication and population. The use of electronic health record and claims data to characterize the available patient population for example remains limited [ 1 , 8 ].…”

“…Common site selection strategies use past trial data to assess how well a site would perform in a prospective clinical trial and different standardized and objective methods have been developed across industry and academia [4][5][6][7][8]. These methods include analyzing factors such as prior trial participation and performance, which are interrogated through database searches in investigator, site, and enrollment data sources.…”

Clinical trial implementation: a primer for neurosurgeons

“…Important points of assessment include whether the specific patient demographic characteristics at the clinical site are compatible with the study aims, whether site infrastruc-ture is adequate to collect and maintain data during the duration of the trial, and whether research staff are available on site. [24][25][26] In addition to preparing for the feasibility meeting, the investigators should confirm the participation of clinical research coordinators (CRCs), clinical trial nurses (CTNs), research assistants (RAs), and any other regulatory personnel at this stage. Furthermore, staff can also begin completing necessary documentation for IRB approval in parallel to feasibility meeting preparation.…”

Electronic health records to capture primary outcome measures: two case studies in HIV prevention research

“…(5,6) However, the adoption of these approaches remains relatively low in practice. (7,8) Here we describe our experience of using EHRs to capture the primary outcome measure -HIV infection or the diagnosis of HIV infection -in two contrasting HIV prevention trials in the UK. PROUD was a clinicbased trial evaluating pre-exposure prophylaxis (PrEP), and SELPHI was an internet-based trial evaluating HIV self-testing kits.…”