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Clinical Research is the testing that has to happen before a doctor can write a prescription for a drug. During the tests, subjects with a specific disease or condition try the investigational drug to see if it is safe and if it works.
The results are sent to the Food and Drug Administration (FDA), a part of our government. Doctors and scientists there review the information about the investigational drug, how well it worked, and what side effects were seen.
If the FDA decides that the investigational drug works and is safe, they “approve” the drug. At that point, a doctor can begin to write prescriptions for that drug.
Pre Clinical Testing
This is the testing that takes place in laboratories. For every 5000 drugs studied, only 5 will be good enough to test in humans.
Clinical Testing
This is the testing in humans. It is split into 4 Phases.
First tests in humans.
Usually 20-100 healthy subjects
Study tries to answer:
- Is investigational drug safe?
- How much should be given?
- How should it be given?
In each Phase, some drugs are eliminated
First tests in people with disease or condition.
Usually up to a few hundred subjects
Study tries to answer:
- Does investigational drug help these subjects?
- How much should be given?
- Is it safe for these subjects?
We know more about the drugs at each Phase.
Usually several hundred to thousands of subjects.
Study tries to answer:
- Does investigational drug work when compared to standard treatment or placebo?
- Is it safe for a large group of people?
AFTER drug has been approved.
Very large studies – thousands of subjects.
Study tries to answer:
- Does the drug work in office setting?
- Is the drug safe in the average patient?
On average, it takes 7 years to go from the first test in humans to approval.
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