DR. SAXMAN: I need to make a couple announcements. I wanted to address an issue that I have been asked a couple of times this morning. I have been asked by a couple of people, "Whom are these recommendations intended for?" So, I thought I ought to clarify that a little bit and I apologize for not doing that yesterday.

We hope that, first and foremost, these recommendations are for you. The major goal, the overriding goal of these State of the Science meetings, is to get individuals together with a wide range of expertise, so that hopefully you have met some people during this meeting that you didn't necessarily know. We hope that you have interacted with some people, and come away with some ideas of things that you can do or things that you might want to do in the context of your own research or the context of your own Cooperative Group or your cancer center.

That is why we make these recommendations from this meeting available on the Web and hopefully in the context of a publication worldwide, so that other investigators in this field can see your deliberations and see the things that you have identified as the most important and critical issues in sarcoma.

The audience also includes CTEP, obviously -- not just CTEP but the Division of Cancer Treatment and Diagnosis. What we do is, we consider these recommendations that you are making in the context of our drug development, clinical trials design and development, the cancer diagnosis people in terms of their development and thoughts about tissue banking and those sorts of things.

That is how we sort of view this, as suggestions and ideas that we can incorporate in terms of biologic, clinical, correlative diagnostics in the context of the activities at CTEP. That is why I hoped -- and I hope this morning -- that the conversation will continue to revolve around science, because that is what we do.

Process is done at a higher level, and that will be more of an issue for the sarcoma PRG. So, if there are issues such as "wouldn't it be nice to have more R01s," I am not saying that is not important, but those are process decisions that are made within a different context. That is done much more at the institute levels. Those kinds of issues are what will be considered as part of the sarcoma PRG that Dr. von Eschenbach talked about last night, which will occur sometime in 2003.

Does anyone have any questions about that, that I can answer? I apologize that I didn't make that a little more clear at the outset.

DR. HEALEY: Can you discuss what exactly is the PRG? We aren't familiar with it.

DR. SAXMAN: Yes, I apologize. Just very briefly, the PRGs -- Progress Review Groups -- were set up originally by Dr. Klausner, probably four or five years ago, and started actually with breast and prostate. The PRGs come out of the Director's office, and the Director brings in a group of experts to examine the NCI portfolio in a specific disease. So, the NCI Director's office puts together all the activities that are being conducted in lung cancer -- grants, SPOREs, basically everything that can be identified as having to do with research in lung cancer.

Then, the PRG meets and discusses what they believe are the critical, important issues that need to be addressed in that disease, and then looks at the NCI portfolio and says, these are being addressed here, that is fine, these are not being addressed and they need to be addressed, and there need to be new processes in place to address them.

It is more of an examination of the overall NCI portfolio that includes processes as it relates to a specific disease.

For example, I can only give you examples of the lung PRG. That is the one that I was involved with. The biology people who were associated with the PRG said; "you know, inflammation is an important component of lung cancer that is not being well studied, and we think some NCI financial resources should go to toward the study of inflammation as it relates to the pathogenesis of lung cancer."

Those recommendations go directly to the Director. The PRG makes a report, and then the 20 people who are the core of that committee -- the overall committee is much larger, so don't start looking around for the 20 individuals -- but those 20 people sit in front of the Director and say, this is where we think more NCI financial, process-type resources should be placed, for these types of studies.

CTEP does not do that. CTEP studies mainly therapeutic interventions, correlative-type studies, as well as drug development types of trials.

Part of our CDP -- Cancer Diagnosis Program-- is involved with the issues related to cancer diagnosis. The cancer diagnosis people were here for part of this State of the Science meeting.

We incorporate the scientific suggestions into the conduct of these clinical studies on drug development. So, that is the difference. We don't get that involved with process and we don't decide how many extra R10s or R01s should go to this, that, or the other.

My understanding is that it was unclear, when Dr. von Eschenbach became the director of the NCI, whether the PRG process would continue. There have been PRGs now probably in -- just off the top of my head -- eight or nine diseases, maybe 10 diseases. Sarcoma had not been one of them.

There were plans to do sarcoma at the end of this year or first part of next year, and I actually had asked Dr. von Eschenbach's office to have him clarify that for you last night, and it sounds like they are going to go ahead with the PRGs now that he, after examining this during his first months as new director, feels that it is an important process to continue.

At this point I am going to turn the meeting over to the co-chairs, Ernie Borden and Murray Brennan.

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