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Big Cancer Bill Aims to Increase Biomarker Research and Use

NEW YORK (GenomeWeb News) – A new bill introduced in the US Senate late last week aims to promote the use of biomarkers in cancer research and treatment, to create a network of bio-repositories, and to coordinate an aggressive anti-cancer strategy through research, detection, prevention, and treatment activities.

The 21st Century Cancer Access to Life-saving Early Detection, Research, and Treatment (ALERT) Act has several provisions that aims to increase biomarker research and use, raise patient enrollment in clinical research, and increase screening and prevention initiatives for underserved populations.

Introduced by Senators Kay Bailey Hutchison (R-Texas) and Edward Kennedy (D-Mass.), the bill also focuses on using inter-agency collaborations and harmonization among different groups to modernize the National Cancer Program.

The full text of the bill was not immediately available but a section-by-section summary was provided by Kennedy's office.

"The leadership that Senators Kennedy and Hutchison are providing comes at a pivotal moment, when decades of scientific effort are converging to produce a revolution in cancer research and care," said American Association for Research CEO Margaret Foti in a statement. Foti called the Act "a critical step in modernizing the national cancer program and in improving our ability to make headway in the war on cancer."

"Cancer is a complex disease and it requires comprehensive strategies to fight it — strategies that integrate research, prevention and treatment," Kennedy said in a statement.

"Our nation declared the War on Cancer in 1971, yet, nearly 38 years later, cancer is expected to become the leading killer of Americans. We must bring renewed focus and vigor to this fight," Hutchison added.

The cost of implementing and pursuing the programs in the bill was not available.

One of the bill's provisions would promote the discovery and development of biomarkers. It would coordinate federal agencies to establish a contract-based program to support development of innovative biomarker discovery tools. It calls for the Food and Drug Administration and the Centers for Medicare and Medicaid Services to create guidelines for clinical study designs that will help generate clinical data.

The bill also seeks to start a demonstration project that would provide limited regional coverage for biomarker tests and would establish procedures for independent research entities to conduct assessments of the efficacy and cost-effectiveness of biomarker-based tests.

"Biomarkers are the new frontier for improving the lives of cancer patients because they can lead to the earliest possible detection of cancer," Kennedy said.

The legislation also aims to coordinate biological resources and advance cancer research technologies. It would establish an entity within the National Cancer Institute to support an interconnected network of biorepositories that have consistent, interoperable systems for collection, storage, annotation, and for sharing information.

It also would link cancer registries to other federal data sources including those at CMS, and at the Centers for Disease Control and Prevention, and the Social Security Administration. Hospitals and ambulatory care centers would receive federal funds to offer patients the opportunity to contribute their biospecimens and clinical data to a clinical registry.

If it becomes law, the ALERT Act also would modernize the role of the National Cancer Institute and its coordination with the National Cancer Program. It would start programs to identify the relevant federal agencies that would coordinate with NCI, would improve the annual budget estimate for the NCP, and would encourage early detection and translational research opportunities.

Another part of the bill calls for the Office of Human Research Protection to use a centralized Institutional Review Board, for improvement in privacy standards for clinical research and clarification of privacy rules to external researchers, and for HHS to study synchronization of research standards.

ALERT also would have NCI report annually on its plans and progress regarding research on cancers with low incidence and survival rates, and would establish a grants program to conduct research on such cancers.

Among other measures, the act also would establish a grant program for the states that would fund colorectal cancer screening and referrals for medical treatment that is similar to the national breast and cervical cancer programs.

The bill also includes a number of measures and programs aimed at the issues surrounding patients and health insurance coverage, including a provision that would enable patients to continue to receive coverage for treatment while they are in clinical trials.

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