The study start-up process averages 5 to 6 months in duration, though 11% of sites are never activated, according to a report by the Tufts Center for the Study of Drug Development (CSDD), which surveyed pharmaceutical organizations, biotech companies, and contract research organizations (CROs) to assess start-up practices and performance.
The research was supported by a grant from goBalto, a San Francisco, CA-based developer of web-based clinical research solutions.
“As stakeholders are increasingly aware that better study start-up processes are linked to shorter clinical timelines, the emphasis has been shifting in that direction,” said Sujay Jadhav, goBalto CEO. “The increasing use of technology and impact on cycle time reductions is a very positive industry trend.”
According to the report, 80% of respondents who invested in technology reported time savings – with CROs investing 10% more than sponsors. As such, the research found that CROs complete all site-related activities 6 to 11 weeks faster than sponsors.
However, 80% of respondents still indicated a need to improve tools and technology to enable more effective processes, with 30-40% of respondents reporting they are unsatisfied with their processes. Those who did report a high level of satisfaction with their processes have 57.5% shorter cycle times, according to the report.
Additionally, across sponsors and CROs, average cycle times are 9.9 weeks shorter (28%) at repeat sites than at new sites.
“It’s difficult to understand why there is so much variation and why there are so many inefficiencies and delays in study start-up, this was the impetus behind this research,” said Craig Morgan, head of marketing at goBalto.
“Numerous factors can adversely impact study startup and its efficiency, in an industry plagued by rising development costs and increasing complexities,” he told us.
Some of these challenges include complex protocols, protocol amendments, competition for sites, contract negotiations, regulatory changes and investigator and CRA turnover, among others.