U.S. Clinical Trials Taking Longer Despite FDA Efforts to Accelerate Drug Development
The average time needed to complete clinical development of a new drug in the U.S. is increasing, outpacing the FDA’s efforts to accelerate drug approval and lengthening the overall amount of time needed to bring a new drug to market, according to a new report.
The average combined clinical trial and approval timeline increased by almost five months between 2008 and 2018, an analysis by the Tufts Center for the Study of Drug Development (CSDD) shows. At the same time, the clinical trial timeline grew by nearly seven months, while the approval phase dropped by nearly two months.
Drugs that fell under the FDA’s expedited review program, however, were brought to market 11 percent faster than those without expedited review. And the trial-to-approval timeline for orphan drugs decreased 12 percent.
The duration of clinical trials increased across all phases, the study shows, with the greatest increase (9.2 percent) in phase 2.
To read a summary of the results, click here: https://bit.ly/32t9vj7.