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Defining Clinically Meaningful Outcomes

Posted 6/6/2014

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  This is another in an intermittent continuing series about our national emerging focus on defining value and quality in health care. There are multiple stake holders in this conversation, but, surely, physicians and patients are right in the center. Almost all of us want to live as long as possible, but it quickly becomes complicated when questions of quality of life are included in the equation. We may feel very differently, one from another, about "what is worth it". There is a whole field of study called "response shift" about changing acceptance--meaning that a person might say: "I don't want to live if I can't walk", and then likely would find plenty of reasons to adapt to those changed circumstances.

  I do suspect that each of us has a line in the sand, so to speak. There is a time for almost all, if not all of us, to say "enough", and the national conversation needs to allow plenty of time and space for physicians and patients to have those important conversations. But I digress a bit. In the interest of full disclosure, this excellent essay from the ASCO Daily News is by my husband. He has been leading ASCO's efforts in this project, and is finding himself in the middle of intense controversy. This essay focuses on current attempts to define clinically meaningful outcomes in research trials; this clearly is linked to public policy and health care costs--but also to common sense.

  Here is the start and a link.

Clinically Meaningful Outcomes in Research: An Important Step Toward Achieving High-Value Cancer Care

In this issue of the ASCO Daily News, there is a discussion of an ASCO initiative to define clinically meaningful
outcomes (CMO) in clinical trials. An undertaking of the ASCO Cancer Research Committee, this endeavor was
stimulated by dissatisfaction with the modest increment in benefit associated with many new antineoplastic therapies and by the realization that in the era of molecular oncology, it should be feasible to set our sights higher.
Despite enormous growth in our understanding of the biology of the cancer process, the track record for developing “breakthrough” drugs that lead to cures of advanced cancers has been disappointing. High-impact agents such as imatinib mesylate or trastuzumab are few in number. Many agents in development never make it to market, and result in modest prolongation in survival at the expense of added toxicities and great financial cost. Over the past several years the U.S. Food and Drug Administration (FDA) has approved a large number of new anticancer . The majority of these extend life by only a few months, if at all, when compared with standard treatments.
Many of these new agents cost between $5,000 and $7,000 per month.1 We must find a way to do better.
As our understanding of the aberrant pathways that drive cancer increases, genomic and proteomic analyses give us the capability of defining subsets of patients who, because of the molecular characteristics of their cancers, might benefit from targeted therapy. Diagnostic assays that validate the presence or absence of a target will follow (in some cases they are already here). At this juncture, “smart trials” that include those patients whose disease expresses the validated target(s) represent the groups that will be the focus of enrollment

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