Research report

Tufts CSDD START II Research Report

Tufts CSDD START II Research Report

Challenges Remain in Study Startup

Tufts Center for the Study of Drug Development (CSDD) conducted an in-depth study on the clinical trial start-up process of biopharmaceutical and CRO companies in order to gather robust, quantitative insights into the selection process as a follow-up to the ground breaking 'START' (Start-up Time And Readiness Tracking) Study completed in 2012.

The new study, START II, focused on the end-to-end process of site identification through site initiation, on the challenges organizations are facing, and on new tools, technologies, and approaches being developed to overcome those challenges. The survey found wide variation between companies, indicating that company practices are highly inconsistent.

The study comprises data from 600 respondents from over 400 unique companies, 54% pharma and biotech 24% CROs with ~80% of respondents having more than 6 years in clinical development/clinical operations.

Areas examined in the survey include:

  • Site selection practices and decision-making, study start up, and site feasibility
  • Implementation of specific tools and resources that impact cycle time, cost, and performance.
  • Factors contributing to poor site selection; improvements made to the site selection and start up processes.
  • Key performance metrics (e.g., cycle time) were gathered.

The research was funded by goBalto, the industry leader in study startup.

Ken Getz
KEN GETZ
Director of Sponsored Research Programs & Associate Professor
Tufts Center for the Study of Drug Development
"Study startup through activation remains one of the most inefficient cycles facing clinical development operations. The impetus behind this follow-up study was to gather hard data quantifying cycle time durations and clinical team experience to identify new insights into this perennial challenge."
Beth Harper
BETH HARPER
President
Clinical Performance Partners
"The results provided some very interesting insights about sponsor/CRO differences, centralized vs. de-centralized site selection and start-up groups as well as the impact that technology has had on reducing cycle times. The comprehensive nature of the survey helped to validate known challenges and issues while providing more opportunities for sponsors and CROs to improve their practices. There's more work to be done but our findings should help point organizations in the right direction to areas that will have the biggest impact."

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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