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Tufts Survey: Trial Site Initiation Process Increasingly Challenging

Posted 09 March 2018 | By Zachary Brennan 

Tufts Survey: Trial Site Initiation Process Increasingly Challenging

Despite efforts to speed the process of clinical trial site initiation, the average time to initiation for Phase II and III studies is now at nearly eight months – a month longer than what was observed a decade ago, according to the results of a new survey from the Tufts Center for the Study of Drug Development.

The survey of 591 sponsors and contract research organizations’ (CRO) employees, including responses from 456 smaller companies and 135 from larger organizations, also found that the time from site identification, site selection and study start-up was an average of 25.7 weeks for repeat or familiar sites, and 35.6 weeks for new sites, a nearly 10-week difference.

And with companies increasingly focusing drug development efforts on rare diseases and targeted sub-populations, the ratio of new sites to repeat sites is expected to increase, Tufts said.

CROs were also shown to outperform sponsors in some metrics. CROs reported spending an average of 4.3 weeks on new site identification, compared to an average of 7.3 weeks for sponsors, according to Tufts.

“Overall, on average 10.9% of investigative sites ini­tiated were never activated, a figure that has not changed during the past two decades and that reflects continued shortcomings in the site initiation process,” the report said.

And between 30% and 40% of sponsors and CROs said they are somewhat or completely unsatisfied with their site initiation processes.

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Categories: Regulatory News

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