[RH77]

It's complicated...

Essentially, a prescription drug is found under a microscope.

4-6 Years later, patients are provided the drug free of charge and compensated for time and travel.

An Independent Ethics Board approves the study in each location tested, the patient signs a consent for treatment, and the testing begins. Treatment is assigned in a double-blind manner, so I (or the doctor) doesn't know if the treatment is the Study Drug or approved drug.

Advantages for the patient: regularly scheduled visits to the doctor and fine-tuning of treatment.

My job: As a third party/impartial observer, I oversee the collection of accurate medical data (translate charts into numbers and database coding), ensure Patient rights, maintain enrollment, Inspect/maintain regulatory documents, and report findings, etc.

Based on the data, about 3 years later the FDA says yes or no to the drug's approval and the public can be prescribed the drug. By that time, I've moved on to another study and the process continues.

I have to travel around my "Region" to the doctors conducting the tests (about 8 sites, every 6-weeks). Right now I'm working on a new Breast Cancer treatment. I like my job -- good stuff and the variety is good. The travel is tough sometimes...

In a nutshell, it's how a drug is approved in it's 10-year average time-span of research.

RH77