The pharmaceutical industry has spent many millions of dollars trying to speed drug development, but it’s taking longer than it did 10 years ago just to launch clinical trials, according to a study by Tufts University.
The average time it takes for drug companies to pick a hospital or clinic to test an experimental medicine, recruit patients, and start a trial is more than 31 weeks — a month more than a decade ago, the Tufts Center for the Study of Drug Development reported Wednesday.
“Despite our best efforts and high investments, it’s actually taking longer than it did in the past,” said Kenneth Getz, an associate professor at the Tufts School of Medicine who oversaw the study.
The report was based on 591 responses to a global online survey of drug makers and companies hired by the pharmaceutical industry to run clinical trials.
Nearly 11 percent of the test sites that are picked for clinical trials never start experiments because of shortcomings in the way the site was selected, disagreements between drug makers and test sites, or the failure to enroll enough patients. That failure-to-launch rate has remained unchanged over the past two decades.
It can easily take 15 to 20 years for a pharmaceutical company to develop and market a new medicine, from the first eureka moment at a laboratory bench to the sale of an approved drug at a pharmacy. The Tufts study focused on how long it takes to start mid- to late-stage clinical trials on patients at hospitals, clinics, and doctors’ offices.
Mary Jo Lamberti, a senior research fellow who co-wrote the study, said a variety of factors contribute to delays in getting trials started: the time it takes for drug makers to negotiate deals with hospitals that they pay to host clinical studies; the difficulty of finding enough patients to participate, which has gotten harder because drug makers are focusing more on medicines for rare diseases; and the hurdles drug makers must clear to get approval from “institutional review boards” that determine whether trials meet ethical standards.
“There are so many inefficiencies in running clinical trials,” Lamberti said. “Those of us who have been in the field a long time weren’t surprised, but it’s not encouraging.”
Getz said another fundamental reason for delays is that clinical trials have become much more complicated. More experimental medicines are gene-based and require far more complex testing.
“We are now performing, on average, close to 200 procedures over the course of a trial,” Getz said. “We’ve moved from primarily a pipeline dominated by small-molecule chemical entities to now large-molecule biologics.”
The study indicated, as prior ones have, that companies contracted by drug makers to organize and perform clinical trials — so-called contract research organizations, or CROs — move faster than pharmaceutical companies do themselves.
CROs get studies started on average in about 29 weeks, compared to about 40 weeks for drug companies.
Over the past 30 years, pharmaceutical companies increasingly have farmed out more of the crucial testing on people to such organizations to make sure drugs are safe and effective.Jonathan Saltzman can be reached at firstname.lastname@example.org.