Federal stimulus funds for comparative-effectiveness research in cancer

Researchers at Fred Hutchinson Cancer Research Center, Group Health Research Institute and the University of Washington schools of Public Health and Pharmacy have been selected to lead four projects backed by approximately $16 million in federal stimulus funding for comparative-effectiveness research in cancer.

The grants establish Seattle as a national hub for conducting such research, which aims to objectively analyze cancer diagnostic tools, screening tests and treatments to determine the optimal choices based on balancing benefits - including effectiveness - and harms, such as cost. Most of these projects involve extensive collaboration between these local institutions.

The American Recovery and Reinvestment Act has dedicated $1.1 billion to fund such research via the Grand Opportunities (GO) grants program of the National Institutes of Health, which supports high-impact ideas that lend themselves to short-term funding. The Seattle-led GO grants, each of which will fund two-year projects, account for approximately one-third of the National Cancer Institute's first investment in the burgeoning field of cancer-related comparative-effectiveness research.

"Cancer is one of the highest areas of health care spending," said Scott Ramsey, M.D., Ph.D., an internist and health care economist who is leading a Hutchinson Center-based project that will lay the foundation for research to evaluate how various cancer genetic tests influence cancer care, outcomes and costs. "We are spending multiple billions on cancer diagnostics and hundreds of millions on genetic tests, for example, but we're not certain what we're getting for all of that money. Are patients living longer? Are they living better quality lives? We just don't have that answer," he said.

The following Seattle-based comparative-effectiveness research projects aim to help provide some of those answers:

Cancer genomics - A $4 million project based at the Hutchinson Center and led by Ramsey, a member of the Center's Public Health Sciences Division and a professor of medicine at UW School of Medicine, will fund the development of an infrastructure to support the "Center for Comparative Effectiveness Research in Cancer Genomics," or CANCERGEN. This public-private consortium will design and conduct prospective, controlled clinical trials of promising cancer genetic tests working in close collaboration with the University of Michigan-based Southwest Oncology Group (SWOG), one of the largest NCI-supported cancer clinical trials cooperative groups. Researchers in the SWOG Statistical Center, co-located at the Hutchinson Center and the Seattle nonprofit Cancer Research And Biostatistics (CRAB), will design the statistical structure of the study and lead data management and analysis. CANCERGEN will develop the tools that help SWOG researchers determine which proposed trials will have the greatest clinical benefit for patients. "Part of CANCERGEN's vision is to position SWOG as a national leader in cancer comparative-effectiveness research," Ramsey said.

"Realizing that vision will go a long way to help achieve the health care reform goal of making cancer treatment more effective and less expensive," he said.

Researchers at the UW School of Pharmacy and the Center for Medical Technology Policy in Baltimore will co-lead the effort.

Cancer diagnostics - A $4 million project based at the UW School of Public Health and led by Larry Kessler, Sc.D., professor and chair of the UW Department of Health Services, will fund research to evaluate the effectiveness of cancer diagnostics - from mammography and MRI to ultrasound, PET-CT, and blood- or tissue-based biomarkers - to determine the extent of disease and plan treatment. "Over the past decade, the field of both medical imaging and laboratory-based diagnostics has taken a quantum leap forward. However, the evidence to determine how to best use these modern technologies in clinical practice hasn't kept pace with the technological developments," Kessler said. "Our research will help providers and patients make better decisions about the use of these technologies, which ultimately will lead to the best possible outcomes," he said. The project, called "Advancing Innovative Comparative Effectiveness Research in Cancer Diagnostics," or ADVICE, will be co-led by investigators from the UW schools of Pharmacy and Medicine, Group Health, Veterans Affairs and the Hutchinson Center, which will serve as the study's data center.

Breast imaging - A $4 million project led by Group Health will support comparative-effectiveness research of conventional and cutting-edge breast cancer imaging techniques to help determine which modalities are most effective for women according to individual patient demographics and risk factors. It will use data from the NCI's Breast Cancer Surveillance Consortium, a nationwide collaborative network of mammography, tumor and pathology registries. With modeling experts from NCI's Cancer Intervention and Surveillance Modeling Network, the project will compare the effectiveness of various breast cancer screening strategies such as film-screen mammography, digital mammography and breast MRI. "A growing body of evidence is showing that screening tests can sometimes do more harm than good," said Diana Miglioretti, Ph.D., a senior investigator in biostatistics at Group Health and one of the project's leaders.

"This study will let us evaluate different strategies for breast cancer screening so we can inform women about the best screening choices for them, based on their own age, risk factors and illnesses." The grant, "Comparative Effectiveness of Breast Imaging Strategies in Community Practice," will be co-led by investigators at Group Health, the University of North Carolina at Chapel Hill, the University of California at San Francisco, the University of Vermont and Georgetown University.

Cancer screening - A $4 million project based at Group Health aims to lay the groundwork for studies to improve the effectiveness of colorectal and cervical cancer screening and increase participation in such screening. "How well cancer screening works in real-world settings depends not only on how well each screening test identifies cancer, but also on patients, health care providers and the context and systems in which health care is delivered," said Diana Buist, Ph.D., M.P.H., an associate investigator in epidemiology at Group Health and one of the project's leaders. "Our grant will study how to deliver colorectal and cervical cancer screening most effectively to populations. The goal is to detect cancer better, decrease the rates of screening's adverse effects and, ultimately, to reduce death from cancer," she said. The project, called "SEARCH: Screening Effectiveness and Research in Community Based Healthcare," will be co-led by Chyke Doubeni, M.D., M.P.H., an assistant professor in family medicine and community health at the University of Massachusetts Medical School. The project will be conducted in collaboration with seven other health-maintenance organizations in the NCI's Cancer Research Network, a consortium of 14 health plans across the U.S., to quickly and effectively translate and disseminate its findings directly into clinical practice.

Cancer treatment - In addition, Group Health is collaborating on a $4 million GO grant based at Dana Farber Harvard Cancer Center that will address two key issues: the costs and effectiveness of treating advanced cancer and the lack of population-based research on patterns and outcomes of cancer care in populations not covered by Medicare, such as those under 65 and the poor. The data from the study will be provided, in part, by the Cancer Research Network, a research-based consortium of health-maintenance organizations that is based at Group Health. "Most cancer research is done in patients in the early stages of their disease, so we know relatively little about patterns of treatment among patients whose cancer has recurred or progressed," said Paul Fishman, Ph.D., an associate investigator at Group Health and co-investigator on the project. "This study will provide evidence needed to support better care for more patients. Our research will be based on a wide range of patients who receive care in the full range of clinical settings where Americans receive their cancer care."

These GO grants represent just a fraction of federal stimulus funding for biomedical research awarded to these Seattle institutions. In total, as of Oct. 1, the UW schools of Medicine, Public Health and Pharmacy had received $79.6 million for 186 projects, the Hutchinson Center had received nearly $40.4 million for 60 projects, and Group Health had received more than $17 million for 15 projects.

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