Individualized Online Clinical Trial Protocol Version 1.0

[gdpawel]

The Musella Foundation's virtualtrials.com is doing something similar to what the Weisenthal Cancer Group is doing. Their brain tumor virtual trial keeps track of patients and displays the results "real time" on the web (virtualtrials.com/volresults).

You select a tumor type (or all tumors to see more data). Then click on a treatment name and you see all patients who took that treatment + each of the other treatments. Click on a number of patients in each group and you get details of the group. Within this group display, click on a patient id and get their details.

But this is the kicker. The Musella Foundation also works on getting insurance companies to pay for these expensive combinations. The most popular one for brain tumors now is cpt-11 and Avastin. It can cost $600,000 a year (perhaps a U.S. Senator could afford that).

The Weisenthal website states there are no one-size-fits-all treatments in this trial and no patient unknowingly receives a placebo instead of a promising new drug he/she had hoped to receive. Patient outcomes will be reported online, in real-time, so patients and cancer physicians will learn immediately if and how patients are benefitting from anti-angiogenic, anti-tyrosine kinase, and standard drug combination therapies identified for them by the new test.

It is the first clinical trial in which novel combinations of emerging drugs are tested for activity in biopsy specimens obtained from each individual patient. While many of these potentially effective drugs are highly expensive, one problem has been in determining in advance who would benefit from them, how to make the drugs more effective by using them in combination. The effectiveness of these drugs can increase exponentially when they are combined with other drugs in various ways.

It is a trial in which each patient receives treatment designed for him/her alone rather than a treatment that serves the financial or research interest of the pharmaceutical company or institution which sponsors traditional clinical trials. Until this new test, no technology existed which allowed for individualized laboratory assessment of candidate drug "combinations" prior to administering them to patients.