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NCI to Restructure Clinical Trials Group in Response to Molecular Advances

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The National Cancer Institute last week said that it will restructure its Clinical Trials Cooperative Group Program in response to advances in molecular oncology and a need to operate more efficiently.

NCI said that it intends to consolidate the nine groups that currently conduct trials in adult cancer patients into four state-of-the-art entities that will design and perform improved clinical trials of cancer therapies. The changes are designed to provide greater benefits for cancer patients and more information for researchers, it said.

NCI is undertaking the restructuring in response to April 2010 report from the Institute of Medicine, which called for a series of changes to the cooperative groups program.

NCI noted that some trials now depend on the genetic profiling of tumors, which necessitates the screening of large numbers of patients in order to find subsets of patients with tumors that demonstrate changes in specific genetic pathways. Such trials also require the acquisition and distribution of many tumor specimens, DNA sequencing, and the matching of genetic information with treatment options.

According to NCI, the modernization and simplification of its current cooperative group structure is partly in response to these advances in the studies it conducts.

"In the last decade, our knowledge of genetic and epigenetic changes that drive the initiation and progression of cancers has increased exponentially," Harold Varmus, NCI director, said in a statement. "Consequently we must assess and improve the methods by which NCI evaluates new therapies that take advantage of our new understanding of many kinds of cancers."

In addition, NCI said that on Jan. 1, 2011, it will impose new deadlines formulated by its Operational Efficiency Working Group intended to reduce by half the time to initiate new clinical studies. It also will terminate studies that do not begin within two years of concept approval.

The NCI Cooperative Group program was founded more than 50 years ago and involves more than 3,100 institutions and 14,000 investigators. The program enrolls more than 25,000 patients in clinical trials each year.