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, a full month longer than the average 10 years ago, according to new research from the Tufts Center for the Study of Drug Development.
Thirty to 40 percent of sponsors and CROs said they were somewhat or completely unsatisfied with their processes for site initiation. Sixty-one percent of total cycle time was associated with study start-up activities such as contract and budget negotiations. Tufts researchers also found wide variation among respondents for average site identification cycle time, indicating “highly inconsistent practices,” according to the report.
Tufts CSDD senior research fellow Mary Jo Lamberti, who led the analysis, said drugmakers have initiatives underway 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 through advances such as increased automation and master service agreements, Lamberti told FDAnews.