Sunday, September 19, 2010

The dark side of clinical trials

As I have noted before, the clinical trials process needs to be modified somehow to help reduce development costs for new drugs among other reasons. One of these reasons is the dark side of clinical trials, as I like to think of them.

Clinical trials sometimes are the last resort for cancer patients. They hope what they are doing will help future patients. I think they often assume that because they are in a trial they are getting the new drug and it will have some miraculous effect on them. But that is not the case.

Clinical trials are run as blind studies. Patients are randomized into different groups - two or three and sometimes more. One group gets the current standard in treatment that they are comparing the new drug to. The other groups get the new drugs or a combination of the new drug and another drug. This means just because you are in the trial doesn't mean you get anything different than you would have otherwise.

Here is the very sad story of two young cousins who both developed melanoma. One got into the trial and received the new drug. The other did not and the unfortunate ending did happen to him. This is the dark side - the people who do not get the new drug that might have saved them.

The article does provide an example of why the FDA is cautious with their approvals. The breast cancer community twenty years ago was screaming for the approval of bone marrow transplant for breast cancer treatment. But they were then found to be less effective than chemotherapy and even could cause death.

This is another example of why the current clinical trial process needs overhaul. But also shows the balance that must be made in comparing the efficacy of new treatments vs. existing ones and the caution with which they must proceed.

1 comment:

WhiteStone said...

In my case, my first chemo (ovarian cancer) was a clinical trial. Treatment included the standard drugs carboplatin and paclitaxel (carbo/taxol) plus the trial drug Avastin or a placebo. When my file was unblinded, I found that I had been getting carbo/taxol/placebo. After recurrence, I did carbo/taxol again. This time WITH avastin. And right now I am in remission. Hopefully for a long time.

There are numerous drug combos available for ovarian...but if I ever run out of the possibles, I would then be willing again to go into a trial if it involved a brand-new, untried drug.

There are pluses and minuses regarding clinical trials. But I'm glad I participated in this one...the results were positive and many ovarians are now using this drug combo.