Drugs

Trial Site Initiation ‘Highly Inefficient’: Tufts

A Tufts Center for the Study of Drug Development survey says that the clinical trial study initiation process remains highly inefficient with wide variation among companies, despite implementation of new technology solutions and practices. “The findings indicate that the site initiation process has become increasingly challenging for sponsors and contract research organizations (CROs) looking to identify and engage more specialized investigators and patient sub-populations worldwide,” the report (subscription or purchase required) says.

The survey found that site identification to study start-up completion takes an average of 31.4 weeks, one month longer than the average time observed 10 years ago. Overall cycle time for repeat sites is 9.9 weeks shorter than for new sites. Some 28% of sites with which sponsors and CROs typically engage were new, and nearly half of those had never conducted a clinical trial.

Tufts says that CROs, on average, complete site initiation for repeat sites 5.6 weeks faster than sponsors, primarily due to faster work on study start-up activities.

CROs also complete site initiation for new sites an average of 11 weeks faster than sponsors, with CROs spending less time on site selection for new sites and less time on study start-up activities.

The survey indicates that CROs rely on advanced technology solutions for study initiation more than sponsors do. Some 47% of CROs reported using clinical trial management systems, compared to 28% of sponsors.

On average, 10.9% of investigative sites initiated were never activated, a figure that Tufts says has not changed during the past two decades and that reflects continued shortcomings in the site initiation process. Sites managed by CROs had higher activation rates than those managed by sponsor companies.

Researchers found that 30%-40% of sponsors and CROs were somewhat or completely unsatisfied with their site identification, selection, and study start-up processes. “The vast majority of companies believe that pooling and sharing data on site performance would enhance site identification, and sharing more information with sites at the outset to assess study feasibility would enhance the site selection process,” the report concludes.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome