'Paradigm shift needed' in trial site selection process
The new solution, called Select, provides sponsors and CROs with a data-driven approach to weighing selection and performance variables to aid in identifying sites and target populations ideally suited to their studies.
“Ultimately, the goal is to reduce the selection of non-active, non-enrolling (NANE) sites, which result in extended study timelines, cost overruns and study rescues,” Judy Luk-Smit, Director of Product Management, goBalto, told Outsourcing-Pharma.com.
Poorly performing sites has long been a challenge for the industry and increasing protocol complexity has created new challenges with feasibility. According to research from Tufts CSDD, nearly 40 percent of all amendments occur before the first study volunteer receives first dose.
“Half of investigative sites under-enroll, 11 percent of sites fail to enroll a single patient, and a mere 13 percent exceed their enrollment target,” added Luk-Smit. “Ultimately, 89 percent of studies meet enrollment goals, but sponsors often have to double their original timelines due to poor enrollment, with poor site selection increasing cost of trials by 20 percent or more.”
And these statistics have remained constant – with slow enrollment as the main issue contributing to such poor outcomes.
Luk-Smit added that poor site selection is a contributing factor in rising healthcare costs, and delays in the delivery of life saving therapies to patients.
“Growth in globalization of clinical trials has also fueled study complexity, leading to a reliance of global affiliates to understand all local processes and approvals, resulting in increased costs and delays,” she added.
Selecting a trial site
According to Luk-Smit, site selection has traditionally been performed using manual, and error prone processes, which use historical, siloed data – ultimately resulting too many non-enrolling and under-enrolling sites being selected.
“A paradigm shift in site selection is needed,” said Luk-Smit, “intelligent site profiling utilizing ‘big data,’ that drives business intelligence and a competitive advantage as competition for high performing sites becomes fierce.”
Select works by scoring various selection and performance variables and integrated workflows, which according to Luk-Smit, allows research teams to collaborate in real-time on site selection from around the globe.
“Selected sites can then be quickly initiated for studies using goBalto Activate’s standard ‘out-of-the-box’ country specific regulatory business process workflows with goBalto Analyze providing continuous, real-time visibility into study status,” she added.
Researchers are able to create a master site profile from numerous data sources, such as industry portals, which offers a view of site performance in order to improve site screening through tailored metrics.
“The site recommendation engine streamlines centralized management and reuse of site profile data, enabling scorecards, ranking, and prioritization of those sites applicable to the study of interest,” said Luk-Smit. Additionally, profiling and ranking can be conducted at the site and country levels.