Year: 2025
Type: conference-paper
Study design: Observational Study
Abstract: Background and Importance The Selection Visit (SV) of a clinical trial (CT) determines whether the site meets the Sponsor’s requirements. The decision to include a site in a specific clinical trial depends on numerous factors, with the characteristics and service portfolio of the Pharmacy Service (PS) being particularly significant. Aim and Objectives To analyse the results and evolution of selection visits for clinical trials conducted in the Pharmacy Service at a tertiary hospital during the period from 2014 to 2023. Material and Methods Retrospective, observational study. All selection visits conducted in the PS during the period from 2014 to 2023 were included. Data were extracted from PS’s SV registry and the CT management programme. Collected data included the date of the SV, protocol code, sponsor, clinical service of the principal investigator, studied pathology, acceptance/rejection of the centre, and whether the reason for rejection was related to the PS. Results During the study period, 247 SVs were conducted, broken down by year of SV: 16 (6%) in 2014; 23 (9%) in 2015; 33 (13%) in 2016; 22 (9%) in 2017; 24 (10%) in 2018; 18 (7%) in 2019; 26 (11%) in 2020; 20 (8%) in 2021; 26 (11%) in 2022; 39 (16%) in 2023. Average SV/year: 25 (range 16–39). In 95% of the SVs conducted, the trial sponsor was the pharmaceutical industry, compared to 5% (12 SVs) where the sponsor was an independent research group. The clinical service with the highest number of SVs was Rheumatology with 82 SVs (33%), followed by Endocrinology 40 (16%); Cardiology 27 (11%); Internal Medicine 25 (10%); Urology 18 (7%); Neurology 16 (7%); and other services 39 (16%). The centre was selected in 148/247 (60%) visits. In none of the cases was the reason for the centre’s rejection related to the PS. Conclusion and Relevance This study shows an upward trend in the number of selection visits conducted and the number of times the centre is chosen. In no case was the reason for rejection due to the Pharmacy Service. References and/or Acknowledgements Conflict of Interest No conflict of interest
Authors: E Sanchez Mira, S Jimeno-Aguado, P Sánchez-Carballo, MT Rabuñal-Alvarez, M Calvín-Lamas, MI Martín-Herranz
Institution: Complexo Hospitalario Universitario A Coruña
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4408376117