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  • Writer's pictureKirk Hartley

Cancer, Costs, Policy and Law – Clinical Trial Management Process Needs a Major Overhaul to

A new expert report calls for significant changes and improvements to the clinical trial approval and implementation process as it pertains to cancer research. Why do these clinical trials matter and why is important to accomplish the changes, quickly ?

1.5 million Americans will be diagnosed with cancer this year. For too many, the only hope for life will lie in a clinical trial. For too many, there will not be an answer, and so 500,000 Americans will die of cancer or its consequences. Some will suffer intense physical pain. Virtually all will suffer significant emotional loss, and for some, depression and worse will follow. Clinical trials are crucial to learning how to better fight and manage the various forms of cancer in order to slow the staggering human costs of cancer.

On the financial side, the numbers are huge. The overall costs of cancer were estimated by NCI at $ 100 billion for 2006. Those costs are also revenues for many academics, researchers and businesses. Cancer is big business, and clinical trial are an important aspect of treatment, and costs/revenues.

Beyond traditional costs and revenues, there are other costs, including tort system costs. As science continues to develop, more and more of the cancers will end as the subject of lawsuits against product manufacturers, chemical companies, premises owners and others.

Those stark realities are just some of the reasons why it’s important that our nation focus on improving clinical trials for cancer treatments. Among other things, one clear need is to speed up approval processes and testing processes to more rapidly translate new science into clinical results. These and other suggested improvements are laid out in the new report from a blue ribbon committee of scientists, with their report issued through the National Cancer Institute. A three page summary is here. The New York Times followed up with an editorial this past weekend to highlight the need for change, including more speed and more focus. For the personal observations of a cancer survivor and doctor who is personally and professionally active in clinical trials as both a patient and an advocate, go here to Wendy Harpham’s wonderful blog: Healthy Survivors.

The entire report is important. From the three page summary, set out below is one part that policy makers and tort lawyers especially need to consider as to biomarkers. When and as the recommendations are followed, changes are sure to follow for tort, medical monitoring and insurance litigation:

"Incorporating Innovative Science

Progress in the treatment of cancer patients depends on the effective incorporation of scientific advances into clinical trials. For example, to achieve the goals of targeted cancer therapy, biomarkers (predictors of a response to a particular therapeutic intervention) increasingly are being used to select which treatment strategy is most likely to benefit individual patients. To advance this field, NCI should, among other actions, mandate that biospecimens collected from patients in the course of Cooperative Group trials be submitted to standardized central biorepositories supported by a national inventory and a defined peer-review process for accessing specimens for study.

The Cooperative Groups should lead in developing and testing innovative designs for clinical trials that evaluate multiple therapies, combinations of therapies, and biomarkers. The National Institutes of Health, including NCI, should take a more systematic, multidisciplinary, and dynamic approach when developing standards for new scientific methods and technologies used in trials, to ensure appropriate and consistent use."

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