Study Assessing Practices and Inefficiencies Associated with Site Selection, Study Startup and Site Activation
Challenges Remain in Study Startup
Based on the previous research on benchmarking clinical trial initiations and the wide variation and inconsistency among organizations, Tufts CSDD conducted a follow up study examining practices and inefficiencies in site selection, study start and site activation. In-depth interviews were conducted with senior level pharmaceutical and CRO executives to better understand the challenges and overall strategies that organizations are using to improve these activities.
A total of 26 interviews were conducted across 21 companies. In some cases, more than one representative from a company was interviewed across functions to gather more complete information and better understand the approaches for activities associated with site selection through site activation. Respondents represented 13 biopharmaceutical companies and 8 CROs across 13 large and 8 mid-sized and small organizations. Interviewees were experienced and were primarily senior level executives occupying director level roles or above.
Interviews examined the key criteria utilized to qualify and identify investigative sites and how practices vary across organizations. Use of repeat sites, experience level of sites, and therapeutic expertise were factors investigated. In addition, novel practices adopted by companies and any solutions currently being planned and implemented were identified. Use of performance indicators including historical site data, and perceived or measured impact on cycle times and cost were also explored. Last, respondents reported the greatest challenges to study start up, site selection and activation and resources or investments that have improved these areas.
The research was funded by goBalto, the industry leader in study startup.
Director of Sponsored Research Programs & Associate Professor
Tufts Center for the Study of Drug Development
"Research conducted by the Tufts CSDD during the past 15 years has demonstrated that, compared to 10 years ago, protocols have more endpoints, procedures, eligibility criteria, CRF (case report form) pages, amendments, and investigative sites."
About Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development is an independent, academic, non-profit research group at Tufts University in Boston, Massachusetts. Our mission is to develop strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical and biopharmaceutical development, review, and utilization. Our path-breaking research informs the research-based industry, regulatory agencies, and the public about the nature and pace of pharmaceutical development.
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