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Comprehensive Research Assessing Study Startup Published in Therapeutic Innovation & Regulatory Science

by Sujay Jadhav

Research focused on broad and holistic practices associated with site identification, selection and activation

Comprehensive Research Assessing Study Startup Published in Therapeutic Innovation and Regulatory Science

goBalto announced today the publication of the peer-reviewed article 'Assessing Study Start-up Practices, Performance, and Perceptions Among Sponsors and Contract Research Organizations' in Therapeutic Innovation & Regulatory Science (TIRS), the official scientific journal of DIA, based on the START (Start-up Time And Readiness Tracking) II study conducted in collaboration with the Tufts Center for the Study of Drug Development (CSDD).

The research focused on the end-to-end process of site identification through to site initiation, on challenges organizations are facing, and 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.

Leading biopharmaceutical companies and contract research organizations (CRO) participated in the study, comprising data from 600 respondents representing over 400 unique companies (65% pharma and biotech, 35% CROs), with nearly 80% of respondents having more than 6 years in clinical development/clinical operations.

Several mini-reports were also produced from the comprehensive START II research report, focusing on areas of particular interest for stakeholders (i.e., consistency, speed, organization and functional structure) requiring further analysis of the research data.

Sujay Jadhav
goBalto, Inc
"We are proud to have had an opportunity to sponsor this research into issues and challenges having a profound impact on study startup efficiencies and subsequent downstream conduct of studies. As stakeholders are increasingly aware that better study startup processes are linked to shorter clinical timelines, the emphasis has been shifting in that direction. The increasing use of technology and impact on cycle time reductions is a very positive industry trend."
Ken Getz
Associate Professor
Tufts CSDD
"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
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."

Participating companies reported cycle times 28% longer on average for new vs. repeat sites, with CROs reporting shorter cycle times compared to sponsors. The percentage of sites never activated remains at 11%, this has not changed substantially in over a decade. Time savings were reported by 80% of respondents who have invested in technology with 30% reporting shorter cycle times than those with inadequate technologies. Only 10% of respondents report that are very satisfied with their study startup processes.

Participating companies reported that many factors contribute to inefficiencies and delays associated with site selection, study startup, and site activation. These factors are discussed in the report as are approaches that organizations are taking to improve study startup performance, including investments in technology solutions and data analytics.

The full report, subsequent mini-reports, as well as the groundbreaking START research conducted in 2012 are available for download from the goBalto Resource Center.

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