Tufts CSDD presents the findings of a new study assessing practices and inefficiencies associated with site selection, study startup, and site activation in starting clinical trials.
Poorly performing sites have long been a challenge for the industry. Research indicates that half of investigative sites under-enroll with 11% of sites in a multi-center study failing to recruit a single patient. Over 80% of clinical trials fail to meet their original timelines, with poor site selection increasing cost of trials by 20% or more. The downstream cost ramifications are significant with a typical Phase III study incurring $2.25 million in expenses for non-active and under-enrolling sites.
Sponsors are under increasing pressure to choose the ‘right’ sites at the same time that competition is intensifying and recruitment rates are falling. The current practice of adding more sites per study and requiring each site to recruit fewer subjects per site is a questionable risk mitigation approach.
goBalto Select, a purpose-built study startup (SSU) site selection and feasibility tool can improve site selection capability by combining internal and external data sources so a complete target site profile can be created. Select mitigates risk factors for recruitment and retention by finding the optimum alignment of top-performing sites with substantial patient databases, and quickly assessing which sites have performed best in similar studies. As part of this effort, Select provides information on start-up time, patient retention and quality. It can also facilitate communications and a desire to build a collaborative long lasting partnership, fostering a foundation of trust and commitment.
Ken Getz, Director of Sponsored Research Programs & Associate Professor, Tufts Center for the Study of Drug Development
Mr. Getz is an internationally recognized expert on R&D and clinical trial management practices and trends, the global investigative site landscape, site management and patient recruitment and retention practices, and the worldwide market for outsourcing clinical research functions. Mr. Getz’s research studies on protocol design complexity and clinical research efficiency and effectiveness, conducted over the past two decades, are considered by many in the research-based life sciences industry to be pioneering work. His 20+ years of original research benchmarking R&D management practices, global outsourcing and the investigative site landscape have contributed to industry-wide understanding of these critical markets and to improvements in management strategy and execution. Learn more at http://csdd.tufts.edu/about/staff_profile/ken_getz
Judy Luk-Smit, Director of Product Management, goBalto
Judy is leading goBalto’s effort to transform site identification, feasibility and selection processes through the creation of optimized business processes, which are supported by facilitating systems, to allow clinical research teams to meet their patient and study goals faster and more efficiently. Since 2008, Judy has worked on leveraging technology innovations to transform the patient/provider engagement experience. Formerly co-leader of Health 2.0’s advisory business to sponsors such as Genentech and UCB, Judy has helped companies identify and leverage digital health technology to transform their patient recruitment/retention and site engagement in clinical trials. Judy began her career at ZS Associates and Monitor Group where she consulted to clients such as Merck, Sanofi, AT&T, and Thomson Reuters.
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goBalto is the industry leader in cloud-based study startup software for the global life sciences industry. Committed to accelerating clinical trials through innovation, product excellence, and customer success, goBalto works with over half of top 20 Pharma and top 10 CROs. Our customers include: Novartis, Genentech Roche, ICON, INC Research and Covance. goBalto is headquartered in San Francisco, with offices in Pennsylvania and Singapore. For more information, visit www.gobalto.com.