The process of selecting clinical trial sites and launching studies, beginning with site identification and ending with study start-up completion, takes an average of 31.4 weeks for Phase II and III studies — a full month longer than the average seen 10 years ago, according to a survey conducted by the Tufts Center for the Study of Drug Development.
Between 30 and 40 percent of 590 sponsors and CROs said they were somewhat or completely unsatisfied with their processes for site initiation, according to the study. Respondents reported that 61 percent of total cycle time was associated with study start-up activities such as contract and budget negotiations.
Tufts researchers found the widest variations among respondents in site identification cycle times, indicating “highly inconsistent practices,” the report said. Nearly three in 10 sites were new, with no prior history of working with a sponsor or CRO.
Tufts CSDD senior research fellow Mary Jo Lamberti, who led the analysis, said drugmakers are trying to improve the timeliness of the site initiation process.
Sponsors are investing in technology and working to make contracting and budgeting negotiations — which can be a significant drag on the process — more efficient, Lamberti told CWWeekly.
“It’s happening, but it’s just not happening fast enough,” she said.
Another potential solution, Lamberti said, is pooling data from clinical sites to counter the siloing of data common among drug manufacturers. Sharing information with sites early on to assess study feasibility could enhance the site selection process, according to the Tufts report.
Tufts researchers found that CROs are more efficient than drug sponsors, completing initiation an average of 5.6 weeks faster for repeat sites and 11 weeks faster for first-time sites. This was “very telling because there isn’t a lot of research out there comparing cycle times between sponsors and CROs,” Lamberti said.
CROs make more use of advanced technology solutions for the study initiation process than drug sponsors, according to Tufts researchers, with 47 percent of CROs saying they used clinical trial management systems compared to only 28 percent of sponsors. More than half of sponsors still rely on spreadsheets, compared to just under one-third of CROs.
In addition, 10.9 percent of initiated sites are never activated — a constant figure over the past 20 years, according to Tufts — with sites being managed by CROs being activated more often.
More information can be found at http://csdd.tufts.edu/.