Thought that you might like a little more information about a double blind drug study. In a double blind drug study the two who are "blind" are the patient and the physician...only the drug company knows who is taking which drugs.
Here's a definition that I found: Double blind: a testing procedure, designed to eliminate biased results, in which the identity of those receiving a test treatment is concealed from both administrators and subjects until after the study is completed.
A six month double blind study seems to be the "gold standard" for the AMA to get drugs approved. Sometimes six months isn't long enough to prove the effectiveness of a drug. Woody has read about a drug that is quite effective for rheumatoid arthritis...but it has never been approved for RA because for the first six months it makes the patient sicker...and then starts showing positive results after six months of taking it. So time periods in these studies are not always long enough to show the positive results of a drug for a certain ailment.
The picture above shows the papers we were given that have information about the double blind study that Woody is going to start in the morning (July 13, 2009). And, I'm sure that lots more papers will be added to these over the weeks that follow.
Everything is very controlled in studies such as Woody is about embark: keeping records of times that he takes the medication; the way he takes the medication (fasting, not fasting); keeping records of how he is feeling; weekly labs with the same lab; weekly doctor visits; periodic scans, etc.
The drug company, Abbott, that is sponsoring this study pays for the study. The drug company will pay for the two drugs that are involved with this study and will pay for some of the testing that has to do with their research. Some general/standard care tests will be paid for by our insurance.
There are 300 people across the United States involved in this research study. Woody is one of ten people at Vanderbilt who will be involved in this study.
This study is researching two investigational drugs for melanoma...which means that the drugs haven't been approved by the Food and Drug Administration (FDA) to treat melanoma. Everyone in this study will receive the chemo drug, Temozolomide, which is not approved for treating melanoma (but has shown some positive effects on melanoma), but is FDA approved to treat two types of brain cancer. This research study is attempting to see if Temozolomide when combined with ABT-888 (also not approved for melanoma) is more effective on melanoma than Temozolomide alone.
1/3 of the participants will receive Temozolomide with 20 mg twice-a-day of ABT-888
1/3 of the participants will receive Temozolomide with 40 mg twice-a-day of ABT-888
1/3 of the participants will receive Temozolomide twice-a-day with a placebo (a pill that does not contain any active drug)
This study could last as long as two years, but will depend on the response of Woody's melanoma cells to the drugs. He can also quit the study at any time. He will be monitored very closely during the whole study...physical exams, lab work, and various scans. The research nurse indicated that they would be able to tell fairly soon if Woody is getting the two drugs or the placebo...guess time will tell! I just pray that what he gets will be effective.
We'll give you a Vanderbilt update when we get home tomorrow. It will probably be another long day at Vandy.
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