Drug Success Rates Remain Low
Applied Clinical Trials
It now costs more than $1 billion and takes more than seven years, on average, to conduct clinical trials and win regulatory approval to market a new drug. Not only are development costs high and rising steadily, but also only one out of every six self-originated drugs developed successfully completes clinical testing and obtains marketing approval.
It now costs more than $1 billion and takes more than seven years, on average, to conduct clinical trials and win regulatory approval to market a new drug. Not only are development costs high and rising steadily, but also only one out of every six self-originated drugs developed successfully completes clinical testing and obtains marketing approval.
New Drug Development Still Risky
This 16% overall success rate—gleaned from the portfolios of the top 50 largest global pharmaceutical companies—has remained relatively constant despite efforts on the part of sponsors to improve the overall quality, predictability, and scope of their clinical research data. Although overall success rates have not changed substantially during the past decade, some trends in phase transition probabilities have been observed: Clinical transition probabilities between Phase i and Phase II and between Phase II and Phase III have gotten lower, suggesting that drug sponsors are becoming more aggressive about terminating unpromising candidates, enabling them to redirect increasingly scarce R&D resources to more promising drug development programs.—Tufts Center for Drug Development, http://csdd.tufts.edu.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Zerlasiran Achieves Significant Sustained Reduction in Lipoprotein(a) Levels with Infrequent Dosing
November 20th 2024Zerlasiran, a novel siRNA therapy, demonstrated over 80% sustained reductions in lipoprotein(a) levels with infrequent dosing in the Phase II ALPACAR-360 trial, highlighting its potential as a safe and effective treatment for patients at high risk of cardiovascular disease.
