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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
