What are clinical trials? The words seem innocuous almost friendly. The previous LESLIE'S WEEK families had mothers who are or were in clinical trials. They volunteered as the method of last resort. Some lived an additional 2 years, some did not. Leslie lived for a year during her clinical trials.
Clinical trials are done in 4 phases: Phase I generally has 20 to 100 volunteers and is the first state of testing in humans. This phase checks for safety. Phase II has between 100 to 500 patients and looks to see how well the drug works. This phase checks for efficacy. Phase III has between 1000 and 5000 patients. The drug must be safe as compared with the gold standard treatment. This phase confirms results. Phase IV is where we have safety surveillance in 'real life' patients. This is the phase where the FDA reviews the phase IV trials.
Stage 4 breast cancer women participate in clinical trials with the hope of improving their quality of life, with the hope of increasing their survival time, and with the hope of helping other women should their life be a part of a cancer breakthrough. Leslie did her trials with all of this in her heart. The drug trails were difficult and took their toll on her; fatigue, pain, nausea, vomiting, physical discomfort and last - she succumbed to the disease in hospice and left this earth quietly.
These women are brave and courageous. They walk voluntarily into the unknown. They endure the side effects. They hope for the best. I met them. They were an inspiration. They do so much for so many and go unrecognized in the clinical trial community. Who has ever heard of these volunteers when they go to buy an approved drug?