The Downside To Clinical Trials

['lizbeth]

GDP and mjm,

My logic is the more drugs approved by participation in the current system, the more options we will have when the randomized clinical trial system is abandoned.

Yet there is small progess with testing for CLL. How did this happen? Instead of a study like I-SPY that is still randomized, how do we get a study with CRSA for breast cancer?

Is the better question who can get this done, and not how? Who has the influence?

We have discussed this back and forth, we have posted our frustrations.

Is it time for us to start a non profit to get the message out to patients and fund CRSA for breast cancer?

[gdpawel]

How do you get a study with CRSA for breast cancer (or any solid cancers)?

There is one problem: (1) Funding.

In the case of most private labs, the relevant technologies are completely public domain, non-proprietary, and very labor intensive. There is absolutely no support from peer review funding organizations. Not the NIH. Not the ACS. All of these organizations have peer review and there has been absolutely no peer-review grant support for cell culture assays, since it became the official policy of the NIH to actively DISCOURAGE grant and contract applications relating to fresh tumor cell culture assays in the late 1980s. The proof of this is the lack of even a single paper (not just randomized trials -- ANY PAPER) relating to cell culture assays for drug response on fresh human tumors for a project funded by the NIH or ACS with the primary goal of researching cell culture assays for the past 20 years! The labs which do this best have absolutely no funds and no resources to support clinical trials. They've always been willing to do "free" assays, but this isn't enough. They have made major efforts over the past 25 years to get cooperative groups to do a clinical trial, where they would supply "free" assays but otherwise couldn't do anything else, with absolutely ZERO cooperation/success. No investor would ever give them a nickel for a clinical trial of non-proprietary, labor intensive technologies with no potential for a return down the road (yes, it's always $$$). It would be like getting an investor to fund a clinical trial for a new surgical technique, which could then be performed by a thousand other surgeons. That's what these assays are -- they are a labor intensive, professional, clinical service. They are not a "product," or a "drug," or a "device," and they aren't even a proprietary technology.

Right now, they are trying to get a randomized trial in ovarian cancer done which would be a three armed trial: physician's choice, molecular assay directed, and cell culture assay directed. The cooperative group is willing to consider the proposal for the trial ONLY if they have the guaranteed funding in advance, which in this case would be $11 million. Again, there's no possibility of getting this from investors or from peer review grant funding organizations (NIH, ACS). The ONLY source is philanthropy. They are actively working on this, but understand the challenge of raising $11 million from philanthropy.