Tufts study: Drug trials are getting longer, harder
More complex clinical trial protocols for new drug candidates are leading to longer trials and increasing difficulty in recruiting and retaining patient volunteers, according to a new study.
The study is from the Tufts Center for the Study of Drug Development, an independent, academic nonprofit research group affiliated with Tufts University, and results from the study were released today.
"During the past decade, there has been a steady increase in the number and frequency of procedures per protocol, and a similar rise in the number of enrollment eligibility criteria and pages per case report form," Ken Getz, a senior research fellow at the Tufts Center and lead investigator on the study, said in a statement. "These protocol design changes are largely due to the nature of diseases currently under investigation and intensifying competition among drug developers."
Getz noted that the increasing complexity of protocol designs is contributing to the growing time, cost, and risk of drug development.
"The rise in protocol complexity represents a significant challenge for drug developers," he said in his statement.
According to the Tufts center, its study is the first ever to quantify the impact of changes in protocol design on clinical trial performance.
Among reported results is that the annual growth rate of unique procedures per protocol grew 6.5 percent between 1999 and 2005.
Clinical trials are also taking longer, the study found.
Between 1999-02 and 2003-06, total time from protocol design readiness to database lock rose from 460 to 780 days, or 69.6 percent, the Tufts center said.
Meanwhile, volunteer enrollment rates dropped from 75 percent for the 1999-to-2002 period to 59 percent in the 2003-to-2006 period, the center said.
(By Chris Reidy, Globe staff)
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