Tufts Report & Removing the Blinders in Site Selection

New study assessing practices and inefficiencies associated with site selection

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.

A fundamental paradigm shift is needed in how sites are selected for 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 sight 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.

Presenters:

Ken Getz
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
KEN GETZ
Director of Sponsored Research Programs & Associate Professor
Tufts CSDD
Barry is a clinical trial and operations management expert. His experiences as an Oncology nurse, clinical trial coordinator and his senior management roles at Novartis, Roche, Merck, and AstraZeneca provides him with a well-rounded set of skills and experiences in the clinical trial space. His passion is transforming study management and trial execution processes through the creation of optimized business processes, which are supported by facilitating systems, which allow sponsor and investigator teams to meet their patient and clinical program goals faster and more efficiently.
BARRY MILTON
Director of Client Engagement
goBalto
Judy Luk-Smit

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