Imagine leading an expedition where every step is more difficult than the last...
The long journey begins in the lab, where scientists spend years testing thousands of ideas. Next, crossing the so-called “Funding Valley of Death” requires the resources and time needed to complete clinical trials, testing safety and effectiveness among what could end up being thousands of volunteers. At the end of this steep financial and scientific climb: Food and Drug Administration approval for a new treatment. Ultimately, it may have taken up to 15 years and more than $1 billion to bring this treatment to the market.
By the end of the expedition, it may have taken up to15 years and more than $1 billion to bring one treatment to the market.
- 3 - 6 Years
Basic Research/Drug Discovery
5,000-10,000 Potential Treatments¹*
250 Potential Treatments¹*
- 6 - 7 Years
Phase I, II, and III
5 Potential Treatments¹*
- .5 - 2 Years
One² approved treatment!
¹ Although we are using the word "treatment," clinical trials also involve medical research studies in which people participate as volunteers to test new methods of prevention, screen, and diagnosis of disease.
² After approval, the product is manufactured for sale on the market, and the process enters Phase 4 (Post-Marketing Monitoring/Clinical Trials). At this point, the FDA monitors for public safety and adverse events, and the sponsor company may begin Phase 4 Clinical Trials to obtain information about long-term effects or to test the product in special patient population.
³ The "Funding Valley of Death" is the financial challenge many promising treatments face in having the opportunity to be scientifically tested in a clinical trial. In many cases, further financial support or partnerships are necessary to proceed.
* The cost of bringing a drug to market depends on a number of variables, but could be more than $1 billion, including approximately $50-840 million for Basic Research/Drug Development and Pre-Clinical/Translational research and approximately $50-970 million to complete all three Phases of the Clinical Trials.
© BrightFocus Foundation, 2013. Design by Alex Ayala