HER2 Support Group Forums - View Single Post - Individualized Online Clinical Trial Protocol Version 1.0

gdpawel · 08-16-2008, 09:31 PM

The very new test, called the Microvessel Vascular (MVV) assay for detecting drug-mediated death of tumor infiltrating endothelial cells is not being marketed beyond the confines of a clinical trial, which will be the most transparent clinical trial in the history of oncology, as all results are going to be reported, in real time, on a week by week, patient by patient basis.

The most immediate application of the MVV assay focuses upon cancer and specifically upon a much-heraled new class of agents called angiogenesis-inhibiting drugs, which work by attacking tumor vasculature and thereby starving cancer cells. One problem with these drugs, in addition to their high cost, is determining in advance who will benefit from them. The other problem is learning how to make the drugs more effective by using them in combination. The new MVV test could help on both fronts.

The test works by measuring drug effects upon endothelial cells which make up blood vessels. Its use could prolong lives, save money, and spare patients exposure to harmful side-effects of ineffective chemotherapy treatments. The effects of various drugs upon endothelial cells can be measured separately from the effects of those same drugs upon cancer cells within the same biopsly specimen.

No one is publishing "real world" studies except laboratories performing cell culture-based tests, which can only do "real world" studies, because their studies require fresh, viable tissue, which must be accessioned and tested in "real time" under "real world" conditions.

Fortunately, receptive people are not so threatened by ideas which dare to challenge and question one-size-fits-all, widgets-on-an-assembly-line medicine. It's certainly not more comforting to see patient after patient succumb, not to the cancer, but to an early demise thanks to wrong-therapy/wrong-dose cookie-cutter treatment.

There are limitations involved with randomized clinical trials. Perhaps the greatest limitation is that it is predictive of population trends, and is not definitive. Clinical trials provide few black and white answers. The problem with the empirical approach is it yields information about how large populations are likely to respond to a treatment. Doctors don't treat populations, they treat individual patients.

Because of this, doctors give treatments knowing full well that only a certain percentage of patients will receive a benefit from any given medicine. They subject patients to one combination chemotherapy after another, just going from one journal paper to another journal paper. They need information about the characteristics that predict which patients are more likely to respond well. The empirical approach doesn't tell doctors how to personalize their care to individual patients.

Source: J Intern Med 2008; 264: 275–287.

08-16-2008, 09:31 PM	#4
gdpawel Senior Member Join Date: Aug 2006 Location: Pennsylvania Posts: 1,080	"Real World" Study The very new test, called the Microvessel Vascular (MVV) assay for detecting drug-mediated death of tumor infiltrating endothelial cells is not being marketed beyond the confines of a clinical trial, which will be the most transparent clinical trial in the history of oncology, as all results are going to be reported, in real time, on a week by week, patient by patient basis. The most immediate application of the MVV assay focuses upon cancer and specifically upon a much-heraled new class of agents called angiogenesis-inhibiting drugs, which work by attacking tumor vasculature and thereby starving cancer cells. One problem with these drugs, in addition to their high cost, is determining in advance who will benefit from them. The other problem is learning how to make the drugs more effective by using them in combination. The new MVV test could help on both fronts. The test works by measuring drug effects upon endothelial cells which make up blood vessels. Its use could prolong lives, save money, and spare patients exposure to harmful side-effects of ineffective chemotherapy treatments. The effects of various drugs upon endothelial cells can be measured separately from the effects of those same drugs upon cancer cells within the same biopsly specimen. No one is publishing "real world" studies except laboratories performing cell culture-based tests, which can only do "real world" studies, because their studies require fresh, viable tissue, which must be accessioned and tested in "real time" under "real world" conditions. Fortunately, receptive people are not so threatened by ideas which dare to challenge and question one-size-fits-all, widgets-on-an-assembly-line medicine. It's certainly not more comforting to see patient after patient succumb, not to the cancer, but to an early demise thanks to wrong-therapy/wrong-dose cookie-cutter treatment. There are limitations involved with randomized clinical trials. Perhaps the greatest limitation is that it is predictive of population trends, and is not definitive. Clinical trials provide few black and white answers. The problem with the empirical approach is it yields information about how large populations are likely to respond to a treatment. Doctors don't treat populations, they treat individual patients. Because of this, doctors give treatments knowing full well that only a certain percentage of patients will receive a benefit from any given medicine. They subject patients to one combination chemotherapy after another, just going from one journal paper to another journal paper. They need information about the characteristics that predict which patients are more likely to respond well. The empirical approach doesn't tell doctors how to personalize their care to individual patients. Source: J Intern Med 2008; 264: 275–287.