Time
- It typically takes from 12-15 years for a new drug to be brought to market.
- There is a "fast-tracking" approval path for AIDS and cancer drugs, but the process still takes several years in these cases.
- Of all the drugs that start out in the early development stage of clinical research, only 1 out of 1,000 drugs makes it beyond the animal-testing phase to testing in humans. From there, only 1 in 5 to 1 in 10 drugs is eventually approved.
- Only 3 out of 10 approved drugs bring in more money in profits than the cost it took to get the drug through the testing phases. Drug manufacturers depend on these few profitable drugs to make up for the financial losses they suffer from the other 7 out of 10 drugs.
Cost
- The major annual costs for a large sponsor or drug manufacturer include the following:
- $150-$200 million for investigators
- $50-$100 million for CROs
- $10-$15 million for central laboratories (special studies)
- $8-$12 million for monitoring
- A typical New Drug Application that must be filed for a new drug to receive approval from the FDA tobe placed on the market requires nearly 70 studies that consist of around 90,650 pages and an overall investment of $359 million, according to "Internet-Based Tools to Facilitate Clinical Trials" by Hassan Movahhed for Genetic Engineering News.
- Delays in the approval process of a drug can cost from $684,931 to $1 million per day.
- In 2000, pharmaceutical companies invested more than $26 billion for new drug development.
- According to Tufts Center for Drug Development, the average cost of bringing a new drug to market is $802 million.
Information taken from "Conducting Clinical Research" by Judy Stone, M.D. Copyright 2006.
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