Introduction
Growing up watching and reading a ton of science fiction made me perceive clinical trial sites as places with advanced technology and scientists walking around with patient data files. However, I later learned that even a level 2 health centre could be a clinical trial site.
Clinical trial sites are vital to how a study will progress. Selecting the right site is crucial for successful patient recruitment, maintaining high-quality data, meeting timelines, and optimizing cost efficiency.
For a health facility to partake in a clinical trial, it must undergo a site qualification process. This procedure involves the evaluation by the study sponsor and/or clinical research organization to ascertain whether the investigator and the clinical site possess the requisite resources and capabilities needed to carry out the study effectively.
More often than not, site selection processes are done by a Contract Research Organisation (CRO). These organizations typically offer various services, including;
✔regulatory affairs
✔site selection and activation
✔clinical monitoring
✔trial logistics
✔pharmacovigilance
✔project management, among other essential functions.
When identifying appropriate sites for a clinical trial, CROs have to factor in different factors. These might include sites that are familiar to sponsors, site’s start-up timelines, contracting templates, study staff, etc
The Gap
I don’t know about you, but I haven’t encountered a signboard at health facilities designating them as clinical trial sites. That’s beside the point; a gap exists in the clinical research community, with insufficient emphasis on enhancing best practices for site success, notably in low-middle-income countries. This offers an opportunity to establish a reliable ‘hospital clinical trial site network’, a crucial step towards capacity building. Global organizations like the Society for Clinical Research Sites (SCRS) have steadfastly advocated for the needs of clinical research sites worldwide.
Siaya County
This blog post series delves into unexplored territories using Data Science tools, embarking on a journey in Siaya County, located in Western Kenya. The primary data is sourced from the Aggregate Analysis of ClinicalTrials.gov (AACT) Database, providing insights into clinical studies registered at ClinicalTrials.gov. The figure above captures the 169 health facilities (blue flags) in Siaya County; red highlights (red stars) represent the trial sites of studies registered between January 1st and December 31st, 2023.
The series does not seek to undermine the rigorous site selection process or provide a magic formula but aims to illuminate nuanced connections for advancing the research community.
Further Reading
- Blog: Site Selection
- Society for Clinical Research Sites
- Git Hub Repository
- Data Source: Aggregate Analysis of ClinicalTrials.gov (AACT) Database
- Background Image Source