DATA AND LOGISTICS
How using technology and data analysis in site selection can improve trial logistics
GlobalData’s director of product development, Amanda Murphy, looks at the critical role that data plays in clinical site selection.
linical trial efficiency is strongest when the sponsor considers supply and storage issues early on during study planning and includes it as a core focus within their site selection strategy. Ideally, much thought goes into treatment storage, dosing regimens, decentralised tactics and other supply chain complications when designing the protocol. However, prioritising supply logistics during the early stages of site selection along with the use of innovative data and technology will further optimise trial execution. Feasibility teams also need to collaborate with supply and logistics teams to account for the changing landscape and new supply chain obstacles that have been triggered by both the COVID-19 pandemic and increase in decentralised trials.
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Data-assessment of supply capabilities Using data is critical in site selection, not just to identify sites with key patient populations and necessary equipment, but also for considering sourcing, storage, preparation, and security complications. When thinking about data to support feasibility, it can generally be classified as syndicated public information, information internal to the sponsor or contract research organisation (CRO) and data the site reports to the sponsor. The ability to organise and leverage these various sources is critical in a site-selection strategy to optimise patient recruitment and reduce the risk of logistical or supply obstacles. Clinical operations teams can use syndicated databases that aggregate public information on sites and investigators to provide insight into their clinical trial experience and potential patient populations. For example, GlobalData’s Feasibility Planner generates a site recommendation score based on an investigator’s past and current experience in an indication, failed inspections,
38 | Clinical Trial Supply Handbook
repeat work with sponsors, and more. This can be helpful for sponsors moving into new indications or geographies, or with protocol designs requiring unique site experience. For example, within a few minutes, a user can identify over 3,000 clinical sites that have successfully completed at least one randomised late-stage oncology trial where the end point measurements require MRI capabilities. Sponsors and CROs also have their own internal knowledge on sites from past trials. The organisation level of this information can vary greatly from sponsor to sponsor and partially depends on how much experience they have within that indication. Whether it is organised in their clinical trial management system (CTMS) from past trials, or being tracked in Excel by regional delegates, this information can be invaluable to a sponsor. It is highly recommended that sponsors save this data early on in clinical trials and include key questions that don’t change frequently, like the site’s therapeutic specialties, institutional review board (IRB) procedures, and pharmacy status. This information can be used to speed up site selection for future trials. Feasibility questionnaires are surveys that most sponsors send to potential sites to vet their experience and interest for a particular trial. Although patient population questions are a priority within these surveys, collaboration between feasibility and supply teams at this step can proactively capture the site’s supply-related capabilities to avoid any surprises during a qualification site visit. Successful study teams need to consider asking the site about temperature-controlled storage, physical security, pharmacy capabilities, sample management, or anything important to the protocol’s logistics. It’s also recommended to allow sites to provide free text feedback on any obstacles they foresee with the protocol and drug requirements.
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