How new treatments are developed

It takes a lot of money and many years to develop a new treatment.

Potential treatments are first identified and tested in the laboratory. Most will not pass initial testing.

Treatments that show promise for humans will enter clinical trials.

If the results from clinical trials show that the treatment is safe and effective, it must then be approved for use by the government of each country.

Around 14% of drugs that enter clinical trials are eventually approved for clinical use in the United States. This means that more than 80% of new treatments (8 out of 10) do not pass clinical trial testing.

Discovery

Identification of a potential treatment

Preclinical development
2 - 4 years

testing in the laboratory in cell and animal models

Clinical trials
3 - 6 years

Identification of a potentaTesting in humans with the health condition.

Overall goal: to find out if the treatment works and is safe.

Regulatory approval

Review and approval by the government.

Cannot be sold without approval.

More information about how drugs are designed and developed can be found at Your Genome.