A Central Institutional Review Board (CIRB) for cancer clinical trials that was created by the National Cancer Institute (NCI), part of the National Institutes of Health, in 2001 helps trials start more quickly (just over a month faster, on average) and thus expedite the time from concept to completion of crucial investigational research according to a new finding. This study of the CIRB was performed by scientists at the Veterans Affairs Palo Alto Health Care System (VAPAHCS) and Stanford University School of Medicine, Palo Alto, Calif., with assistance from NCI and appears online October 19, 2009 in the Journal of Clinical Oncology.

Over the past 40 years, more than 1,700 institutions in the United States have enrolled up to 20,000 patients annually in phase III clinical trials coordinated by NCI and have used separate IRBs to monitor research involving patients. Federal regulations require that most NIH-funded clinical trials be monitored by an IRB.

To determine whether a new treatment is safe and more effective than current treatments using clinical trials is a lengthy process that can take up to 10 years and cost more than $1 billion, in some cases. Many researchers have complained that administrative requirements, including IRB oversight, are delaying the release of new treatments. One solution NCI proposed was to form a CIRB to conduct IRB review of large, multi-site oncology trials.

“Mounting a CIRB that is nationwide in scope has been challenging for NCI due to the complexity involved in assuring high-quality protection for study participants while attempting to speed the process,” said Jeffrey Abrams, M.D., associate director of NCI’s Cancer Therapy Evaluation Program. “For all the volunteer reviewers and participating sites, this study provides objective confirmation that a centralized approach significantly improves the overall process for participants in multi-site trials.”

The study assessed whether use of NCI’s CIRB was associated with lower effort, time and cost in processing adult phase III oncology trials, which are the gold-standard of trials for validating whether a therapy becomes a new standard of care. Early phase trials (phase I and II) and pediatric trials were not included in the analysis due to the lower patient enrollment populations required.

Clinical trial sites that are not enrolled with the CIRB must have their local IRB conduct a full board review as they would with any research study. Sites enrolled with the CIRB have their local IRB conduct a facilitated review, which is a review category requiring only that the local IRB chairperson or designee signal acceptance of the CIRB’s review.

To determine whether the CIRB was achieving the hoped-for efficiencies, researchers compared clinical trial review at sites affiliated with the NCI CIRB with the review at unaffiliated sites that used their local IRB. Oncology research staff and IRB staff were surveyed to understand differences in effort, timing and costs of clinical trial review. CIRB affiliation was associated with faster local review (about 34 days) and about six hours less research staff effort. Many clinical trials sponsors value faster and more predictable reviews and often pay commercial, fee- for-service, central IRBs to perform reviews.

Affiliation with NCI’s CIRB was also associated with a savings of $717 per initial review, of which about half was associated with time savings for research staff and the remainder was associated with savings for the IRB staff. Overall, the program resulted in a net cost of $55,000 per month for NCI, but the CIRB could actually save costs if more sites were to use the CIRB. Moreover, this net cost estimate does not include the benefits of bringing new cancer therapeutics to market more quickly.

“Efforts are underway to expand enrollment in the CIRB and to encourage sites to use the CIRB to minimize administrative inefficiencies,” said lead researcher Todd H. Wagner, Ph.D., health economist, VAPAHCS and Stanford University School of Medicine, Palo Alto, Calif., “and based on our research, increased efficiencies and net savings are likely.”

Reference: Wagner TH, Murray C, Goldberg J, Adler JM, and Abrams J. Costs and Benefits of the NCI Central IRB. Online October 19, 2009. JCO.

The Veterans Affairs Palo Alto Health Care System (VAPAHCS) comprises three divisions, including a large tertiary care facility. It is affiliated with Stanford University Medical School and provides a full range of patient care services with state-of-the-art technology, as well as education and research. Comprehensive health care is provided through primary care, tertiary care and long-term care in areas of medicine, surgery, psychiatry, physical medicine and rehabilitation, neurology, oncology, dentistry, geriatrics, and extended care. VAPAHCS has 897 operating beds, and is home to a variety of regional treatment centers, including a Spinal Cord Injury Center, a Polytrauma Rehabilitation Center, the Western Blind Rehabilitation Center, a Geriatric Research, Educational and Clinical Center and the National Center for PTSD.

Source
The National Cancer Institute

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In a unique partnership, the Stanford University School of Medicine and the Palo Alto Medical Foundation will collaborate on a research project that aims to improve outcomes for breast cancer patients.

The project is the brainchild of Richard Levy, PhD, a longtime community philanthropist and business leader, who said he saw an opportunity for the two medical centers to share expertise on a subject that is of great interest to him - improving cancer survival. He and his wife, Susan, will provide a gift of $2.1 million for the three-year study, which will focus on both the medical and psychosocial factors that contribute to cancer treatment and survival.

“From the point of view of patients, what makes for good health is good technology and good environmental factors, such as the doctor/patient relationship, nutrition, exercise and lifestyle factors,” said Levy, a resident of Portola Valley, Calif. “Patients need both. Here we have two world-class institutions in both areas. It’s a natural partnership.”

Although scientists at the two medical centers have worked together over the years on many projects, this is the first time the two institutions have officially partnered with the intent of building a long-term collaborative relationship in research.

Levy is the former president and CEO of Varian Medical Systems in Palo Alto, where he has spent the last 40 years. He has longstanding ties to both Stanford and PAMF. He has served on the board of PAMF for the past 10 years and its parent, Sutter Health, for the last three. A nuclear chemist by training, he and his colleagues at Varian worked closely over the years with Stanford scientists in the Department of Radiation Oncology to pioneer linear accelerators for cancer treatment. Levy retired as CEO in 2006 but remains the company’s chairman of the board. He is also active in initiatives involving philanthropy and health-care reform.

Levy said he hopes the study will not only lead to improvements in cancer care but also point to ways of reducing medical-care costs nationally.

“If Palo Alto and Stanford can find a way to provide better care at lower cost, that will set an example for other communities,” he said.

In the study, physicians and scientists at both organizations will follow the journey of hundreds of patients throughout the course of their treatment with an eye to understanding the role of cancer biology and different patterns of care in outcomes and quality. The researchers will document every aspect of the patients’ treatment, including all tests, drug infusions, surgeries and radiation treatments, as well as nonmedical support they receive, such as yoga, alternative therapies or group therapy.

“By harmonizing data from the two institutions, we will have a deep data source that will enrich the understanding of the clinical course and outcome of the disease,” said Ralph Horwitz, MD, professor and chair of the Department of Medicine at Stanford. “We can look comprehensively at the biological, clinical, social and environmental factors that influence outcomes.”

The researchers chose to study breast cancer because it is a common disease in which there are basic protocols, though there are many variations in how patients and their doctors choose to pursue them, said Hal Luft, PhD, executive director of the Research Institute at the Palo Alto Medical Foundation. For instance, women may choose breast-conserving surgery or full mastectomy, he noted, or they may opt for different chemotherapy plans with different toxicities and frequencies.

“So there is a decision-making process for women - how do they choose among these options?” Luft said. “We will try to capture this information and analyze how women’s preferences and best clinical practices can be combined with other factors to achieve optimal treatment.”

The researchers also will aim to capture information on the women’s experiences - their anxieties, concerns and satisfaction with the process - through interviews and patient journals.

“There is a kind of road map that physicians and patients follow. But they may deviate from that road,” said Amar Das, MD, PhD, principal investigator at Stanford and assistant professor of medicine and of psychiatry and behavioral sciences. “The question is by how much? And does it matter? Are patients more satisfied going down one path over another, and what impact does that have on survival?”

All the data from the study will be collected in a new secure electronic database known as OncoShare, in which patients and their treating doctors will remain anonymous. The researchers said OncoShare will be the first large-scale research database to incorporate comprehensive information on breast cancer characteristics, practice variation and treatment effectiveness that can help answer pressing questions on how biomarkers, cancer genetics, patient choices and patterns of care all interact and relate to outcomes. Patients will have to provide consent to be included in the study.

While the focus of the study is on breast cancer, Levy said ultimately he would like to see the approach applied in other diseases as well, such as heart disease, diabetes and other types of cancer.

“There are plenty of other common diseases where the quality of health is related to both technology and lifestyle,” he said.

The Stanford University School of Medicine consistently ranks among the nation’s top 10 medical schools, integrating research, medical education, patient care and community service. For more news about the school, please visit http://mednews.stanford.edu. The medical school is part of Stanford Medicine, which includes Stanford Hospital & Clinics and Lucile Packard Children’s Hospital. For information about all three, please visit http://stanfordmedicine.org/about/news.html.

Source
The Palo Alto Medical Foundation for Health Care