Clinical Trials

Hey you's guys, (that's a term that includes the ladies from when I was a kid)

Instead of reading a post about a "study" of a mouse being od'd on Zytiga, just go to the source: clinicaltrials.gov

You'll find everything you need to know, period. These are trials for humans, for anything you can think of, all over, I want to say the world. But at least North America.

Joe

[Hidden]

I prefer the trials that involve more than one person. "It works for me" doesn't mean anything.

[Hidden]

I am a proponent for clinical trials. If it works for you great. If it helps others down the road, still great. A win-win for everybody in kicking this bastard's butt.

Yet, I think blind studies are cruel. Give everyone the possible benefit.

Gourd Dancer

[AlanMeyer in reply to Hidden]

Many years ago there was a trial of a new breast cancer drug in Canada. To everyone's surprise, people who got the drug were more likely to die than people who got the placebo. It turned out that nurses discovered that all the even numbered women who joined the trial got the placebo and the odd got the investigational drug (or vice versa, I don't remember which). The nurses who evaluated people for their eligibility were giving the women with the most aggressive cancers the drug and those with the less aggressive cancer the placebo. They were sympathetic to the patients and wanted to give the sickest patients the best chance. They believed they were doing the right thing.

That's just one of many kinds of errors that can, and generally do, occur if the trial is not blinded. It sounds cruel, but really the evidence is unreliable if the trial isn't double blinded (double meaning neither the medical staff nor the patients know who got the drug and who got the placebo.)

Alan

[Hidden in reply to AlanMeyer]

Alan, when was this study? How long ago? It is my understanding is that today placebos are not used if a patient would be put at risk by not having effective therapy. Further that these studies should compare an existing therapy with an approved therapy. And most likely a Class 1 trial rather than a Class 2-4.....

I had previously read about this particular study and wondered where the safety of the amount of dosage was in question and not the potential therapy involved.

I should have clarified by statement to include the phase, "Class 2 and beyond". As Doctor Amato told me early on, "We found out in 1978, how to cancer. The trick was how to kill cancer with out killing the patient first."

GD

[Hidden in reply to Hidden]

I was on a Phase 3 study just two years ago for men with St. 4 PCa, with no mets. That study included men on placebo.

Joe

[AlanMeyer in reply to Hidden]

I think the study was one of the very early ones, it may have been in the 1950s or 60s, back in the days when people were first beginning to work out what a clinical trial ought to do.

I think that a common technique today is to use a placebo but, if it is a potentially terminal illness, like cancer, all patients may still receive the standard of care, whatever that is.

It's a complicated issue that poses different problems for different experimental treatments, different standards of care, and different patient populations. I think there are now ethics reviews of all FDA approved clinical trials and they help avoid the kinds of problems that would otherwise face patients entering the trials.

Alan