Ember
Senior Member
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So with regard to the SOW again - How is having a clinical definition which is seperate from a clinical trials and research definition going to "advance" clinical care?? And how especially will this "advance" drug development? This especially seems illogical to me. Shouldn't drug developement be tied to the clinical trials and research diagnosis??
When DHHS first announced its intention to award the IOM contract, I asked the same question: “Why is a clear distinction needed between a clinical definition and a research case definition? The International Consensus Panel argues that 'it is imperative that research for ME be carried out on patients who actually have ME.'”I guess I need to read for a better understanding of clinical criteria and research criteria. Maybe this seems kind of chicken-and-the-egg to me - that I don't understand which defintion comes first, or is most important, or how they affect each other. Seems like they should develop hand-in-hand, but I'm (obviously probably) not a science person...
Patients may have themselves to blame, however, for this development. At the June 2102 CFSAC meeting, PANDORA lobbied for the development of two case definitions:
Also, there should be two definitions, one for research and one for clinical use. One is more narrow, the other is broader.
As a result of Dr. Susan Levine's argument at that CFSAC meeting, Dr. Lee began to focus on a broader clinical definition:Also, remember, the Fukuda is a research definition. I spoke to a CDC person in the audience. I told her I did not get to mention in the testimony that the primary care physicians go to the CDC website for info. But, the Fukuda is the only criteria on there. Yet, it is a research definition. So, without a clinical one on there, they will use the Fukuda.
And after I said that to her, when they started talking definitions, I really liked that Dr. Susan Levine, right out of the gate, said that there needs to be two: research one, which is very narrow; and clinical one, which is more broad.
Absolutely.
In its September and October statements, PANDORA modified its position: “At least three different definitions are needed: a clinical definition, a more narrow research definition, and a clinical pediatric definition, and these should be developed together from the same initiative.” The September statement argues, “Numerous researchers tell us that a research definition should be narrower than the clinical definition. A narrower research definition ensures a more pure cohort, which will more likely lead to more biomarker discoveries.” PANDORA's statements ignore, however, the experts' position:The thing that Susan started off with was two definitions. So we have the research definition and we have the clinical definition. I hear over and over again how people with ME/CFS go through many physicians before they find one who can figure it out. So we need to get the primary care physicians on board for at least the clinical definition. I think that we have to bring some of those people to the table.
PANDORA ignores too the fact that the ICC is both a clinical and a research definition.As leading researchers and clinicians in the field, however, we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care. This step will facilitate our efforts to define the biomarkers, which will be used to further refine the case definition in the future.