The process of developing therapies is Herculean: billions of dollars and dozens of years often spent on UNSUCCESSFUL treatments. A successful treatment typically requires another billion dollars, and a couple of years just to survive the FDA review period. These systems allow for less than 1% of potential new therapies to reach the market in Phase IV.
For those reasons and more, the average attempted clinical trial results in so much time and money, and so little return. Just about anyone can hear that and conclude that there has to be a better way. In 2012, the FDA passed the Food and Drug Administration Safety and Innovation Act (FDASIA.) This program is intended to incentivize breakthroughs while discouraging incremental developments.
Imagine: In research and development, A larger portion of money and time is placed on incremental improvement… while therapy which extends survival a month or two might be appreciated, the FDA and the supporters of FDASIA wanted to place priority on breakthrough treatments… drugs and therapies that would provide “Substantial Improvement Over Existing Therapies.” This prioritization is having a positive influence on the entire research and development process.
Friends of Cancer Research, a cancer research, think tank and advocacy group, found that the FDASIA has been a boon to the most promising therapies. Even better, Friends found that FDASIA wasn't being abused as a shortcut for drug approval. They found that breakthrough drugs are shaving 2.2 years off of the average pre-market development time.
With over 300 breakthrough applicants, 100 breakthrough designations, and 30 breakthrough approvals, “game-changing” therapies now get preferential recognition and acceleration, at a rate of approximately 10%!
10% may seem small, but compared to the >1% development rate involved in the standard R&D process, that's a huge leap in progress. Laboratories who commit to unprecedented innovation will see ten times the approval as research teams working on moderate improvements.
Go big or go home! The message is clear, the FDA, FOCR, and the American public are tired of the financial and intellectual drain that conservative developments are having in the cancer treatment sector.
Do you have ideas for breakthrough therapies, or perhaps breakthrough approaches to increasing enrollment in clinical trials? Sign up for the Clinical Trials Innovation Prize today!
For more, read this article: Breakthrough Designation is Working