Urology Research Department

Drug Development Overview

It takes approximately 12 years and costs a company approximately 359 million dollars to get one new medicine from the laboratory to the pharmacy shelf. Approximately 1 in every 5000 new drugs is ever approved by the Food and Drug Administration.

The clinical trial process in the U.S. evaluates a drug candidate's safety and effectiveness.

Preclinical Testing

• Laboratory and animal studies to show biological activity of the compound against the targeted disease
• Safety
• Approximately 3 and ½ years

Investigational new drug application (IND):

• Filed with the FDA to test the drug in people
• The IND becomes effective if the FDA does not disapprove it in 30 days
• Shows results of the previous experiments
• How, where and by whom the clinical trials will be conducted
• Chemical structure of the compound and how it works
• Toxicities found during the animal testing
• How the compound is manufactured
• Must be reviewed by the Institutional Review Board (IRB)

Phase I Clinical Trials:

• Approximately 1 year
• 20-80 normal healthy individuals
• Safety profile including safe dose range
• Determines how the drug is absorbed, distributed, metabolized, excreted and the duration of the action
• Patients usually kept in-house for the duration of the study

Phase II Clinical Trials:

• Approximately 2 years
• Controlled studies 100-300 volunteer patients with the disease being studied
• Efficacy of the drug

Phase III Clinical Trials:

• Approximately 3 years
• 1000-3000 patients in clinics and hospitals with the disease being studied
• Safety
• Efficacy
• Adverse effects

New Drug Application (NDA):

• Following the completion of all three phases of the clinical trials
• Filed with the FDA to demonstrate safety and efficacy
• Must contain all of the scientific data the company has gathered
• Approximately 100,000 pages or more
• By law the FDA has 6 months to review the NDA
• Average review time usually exceeds this by many months

Approval:

• Once approved the drug becomes available for MD’s to prescribe
• The company must continue to submit periodic reports to the FDA including adverse reactions and quality control reports
• Some times additional studies are required (Phase IV) to evaluate long term effects

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