In STAT News, Mary Jo Lamberti, a research fellow at the Tufts Center for the Study of Drug Development, unveiled an analysis of the amount of time it takes to initiate a clinical trial.
Since winning the White House and tapping Scott Gottlieb as Commissioner of the U.S. Food and Drug Administration President Donald Trump has urged speedier approval of medications.
Earlier this month Congress approved federal right-to-try legislation that could give terminally ill patients access to experimental medications that have yet to be approved by the FDA as a last-chance effort at staving off death from disease.
Yet, all of that urging for a speedier approval process or access to experimental treatments has not been able to speed up the time it takes drug developers to take their therapies out of the pre-clinical stage and into the clinic. This morning in STAT News Mary Jo Lamberti, a research fellow at the Tufts Center for the Study of Drug Development, unveiled an analysis of the amount of time it takes to initiate a clinical trial. Once the preclinical work is done and a company has plans to move into Phase I testing, it takes an average of eight months “to get from site identification to study startup completion when all sites are initiated and ready to enroll patients,” Lamberti said. That has been the case for about 10 years, according to that organization’s global study that included more than 400 different drug makers and contract research organizations.
There is a myriad of factors that play into that eight-month time-frame, including financial issues, site selection and increased completion from other organizations.
“More global trials are being conducted, which brings the challenges of country selection and initiation, regulatory compliance, and standardizing informed consent language to ensure the protection of patients participating in the trial,” Lamberti noted.
Additionally, Lamberti noted that changes in study design, issues with recruiting trial patients and contract problems with investigative sites can all work against launching a trial on time. Cost can also play a big factor in slowing down the start of a trial. In its report, Lamberti said initiating a site for the Phase I trial can run between $20,000 and $30,000, with another monthly fee on top of that.
While it can be expensive and time-consuming to initiate Phase I, the report does point out some factors that could potentially speed up the process. One key is the advantage in efficiency that contract research organizations have in kickstarting trials, as opposed to the pharma and biotech companies themselves. CROs, Lamberti said, have made investments in technology that include clinical trial data management systems and have also conducted market intelligence research on investigators and sites.
Another factor that could speed up the trials is to have companies “pool and share data on investigative sites.”
“Our study found that startup times were faster for repeat trial sites compared with new ones, or those that an organization has not previously worked with, and companies should give more consideration to these locations,” Lamberti reported.
As the FDA hands out more designations for experimental treatments there is a need to make clinical trials more efficient, Lamberti added. To do so, companies must become more efficient.
