New Tufts CSDD Study on Site Selection and Initiation

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. Sponsors typically have to double their original timelines due to poor enrollment, with poor site selection increasing cost of trials by 20% or more. The new Tufts CSDD study offers insights into new approaches to driving study initiation efficiency and delivering higher levels of study conduct performance.

Site selection is typically performed using manual, error prone processes, using historical, siloed data, resulting in the selection of too many non-active and non-enrolling sites (NANE). 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 creating a targeted site profile which will better inform your decision making process. Select mitigates risk factors for recruitment 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 site capabilities start-up cycle time, patient availability and data quality. In addition it facilitates communication and enhances collaborations to develop long lasting site 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
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.
JUDY LUK-SMIT
Director of Product Management
goBalto
Judy Luk-Smit

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