Research focused on broad and holistic practices associated with site identification, selection and activation
goBalto, Inc., the leading provider of cloud-based clinical study startup solutions, announced recently 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) (journals.sagepub.com/doi/abs/10.1177/216847), 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.
“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,” said Sujay Jadhav, goBalto’s CEO. “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.”
“Study startup through activation remains one of the most inefficient cycles facing clinical development operations,” said Ken Getz, Associate Professor at Tufts CSDD and the principal investigator on the START II study. “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.”
According to Beth Harper, President, Clinical Performance Partners and co-author on the study, “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, visit www.gobalto.com/resource-center.
About Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality an efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues. For more information, visit csdd.tufts.edu.
goBalto is the industry leader in cloud-based study startup software for the global life sciences industry, offering the only complete end-to-end platform for starting clinical trials, from site identification, feasibility assessment and selection through to activation, with comprehensive metrics to track adherence to timelines and budget. Committed to accelerating clinical trials through innovation, product excellence, and customer success, goBalto works with four of the top five CROs and more than two-thirds of the top 25 pharmas. Our customers include: Allergan, Covance, CMIC HOLDINGS, Genentech Roche, ICON, INC Research, Novartis, PSI CRO, and Worldwide Clinical Trials. goBalto is headquartered in San Francisco, with offices in Philadelphia and Singapore. For more information, visit www.gobalto.com.