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Individualized Online Clinical Trial Protocol Version 1.0

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The traditional meaning of Health 2.0, according to Jane Sarasohn-Kahn's "Wisdom of Patients" has been the use of social software and light-weight tools to promote collaboration between patients, their caregivers, medical professionals and other stakeholders in health.

An example of this in cancer medicine is Individualized Online Clinical Trial Protocol Version 1.0 by the Weisenthal Cancer Group, a Phase II evaluation of individualized cancer treatment with traditional cytotoxic chemotherapy, targeted anti-kinase drugs and anti-angiogenic agents.

With most clinical trials, investigators never give out information as to how people are doing. Most trials are failures with respect to actually improving things. The world doesn't find out what happen until after a hundred or 500 or 2,000 patients are treated and then only 24 hours before the New England Journal of Medicine publication date.

Individualized Online Clinical Trial Protocol Version 1.0 is a totally transparent clinical trial. Every patient who decides to enter a study should know what happened to previous patients. Patients are treated in real time, on the Internet, with the whole world watching to see how they do. It includes weekly progress reports, and if individual patients want, their own blogs as to how they are doing.

Stages have been implemented for a rather innovative clinical trial with cell culture assays, "real time" on the Internet. The purpose of the study is to show that cell culture assay technologies for "targeted" agents really do work. The short-term future of cancer therapeutics is combinations of "targeted" agents.

They are not "marketing" the test 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, on the website.

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.

Contact information: 
Call or e-mail Weisenthal Cancer Group and ask to speak with Connie Rueff, the study coordinator. She will answer any questions you may have and will help you to determine if you are a candidate for entry. (714) 596-2100 or connie@weisenthalcancer.com
Weisenthal Cancer Group
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