Effort aims to improve care quality, offer new treatment options
By JULIE MINDA
When community hospitals participate in biomedical research, they not only can help researchers learn more about certain diseases and bring about new treatments and protocols — they also can provide their own patients with access to medical options that otherwise may be out of their reach.
But, generally speaking, only academic medical centers have had the resources, capabilities and expertise to initiate early-stage clinical research trials of drugs and untested devices, and otherwise translate bench research into breakthrough products and services with the promise of improving patient care and health outcomes.
Englewood, Colo.-based Catholic Health Initiatives is opening up the field by enabling more community hospitals to engage in medical research.
Melissa Roden, vice president of quality at CHI's Memorial Health Care System, Chattanooga, Tenn., said it is part of CHI's mission to be able to offer patients treatment options and access to potentially groundbreaking therapies in this way.
CHI's five-year-old Institute for Research and Innovation has created two centers to provide research infrastructure at the system level — such as financial backing, business development support, information technology systems, and access to legal and financing specialists — back-shop services that facilitate research at the community hospital level. System-level researchers provide the scientific know-how that helps the facilities conform to research protocols.
One center, the Center for Clinical Research, supports participation in trials for drugs, diagnostics and devices invented or marketed by other organizations. The other, CHI's Center for Translational Research, is ramping up to contribute earlier in the continuum of discovery medicine. According to Dr. Kenneth Kashkin, president and chief executive of the Institute for Research and Innovation, it will support efforts to identify biomarkers, drug targets, drug mechanisms of action, and therapeutic response.
Virtual brain trust
CHI's innovation institute has a national office team plus virtual teams of research and innovation specialists — recruited from within and outside the system — staffing its centers. In addition to the clinical trials and translational research centers, the institute has a center focused on health care delivery system innovations, such as virtual help centers, robotics and population health management.
Jeff Otto, national director for the Center for Translational Research, said he is unaware of any other health care system creating such a comprehensive, centralized research model.
In the past, even if clinicians at community hospitals had patients who met a national research study's participation criteria, Kashkin noted, it often was difficult for them to participate because such research programs "in a community (hospital) setting are rarely profitable, despite reimbursement from research sponsors."
Roden said this is partly due to the fact that it takes extensive personnel, infrastructure, staff training and even equipment investment to take part in research studies. With CHI assuming these expenses from facilities, the hospitals can participate without that financial burden. "This is a huge relief for us," Roden said. "With the institute focusing on back office work, facilities can focus on the patient."
Kashkin added, "For community care providers, research economics are a matter of infrastructure, scale and quality. There is only profitability and high quality when leveraging economies of scale — and these scales are rarely reached in singular hospitals. And so, under (our institute) a collective strength is created where we pass the tipping point of loss to profitability and quality."
Clinical trials
Roden and her colleagues at Chattanooga's Memorial are helping to establish the Center for Clinical Research, which soon will begin assisting CHI facilities in learning about the wide variety of clinical trials open to enrolling patients. Most such research takes place in outpatient environments. The center will support CHI hospitals, facilities and practitioners who wish to enlist in the studies and will help them process data and results.
Sometimes the protocols being tested are experimental, other times the tests are of new uses of existing drugs and devices. Trials are happening in numerous realms of medicine, but are most common in cardiology, oncology, gastroenterology, orthopedics and pulmonology, Roden said.
Kashkin noted that while many CHI facilities already participate in clinical trials, the efforts of the Center for Clinical Research will boost their capabilities and will expand participation throughout the CHI system.
Kashkin said when it comes to both clinical research involving trials of devices and treatments and translational research involving the use of biospecimens to learn about disease markers, the corporate, government and academic researchers need access to a large number of patients in order to identify potential research subjects who have specific characteristics and conditions. CHI can create a large cohort from which to identify candidates by pooling patient profiles from its network of 76 hospitals and other facilities into one large group.
Genomic research
The hub of activity for the Center for Translational Research is a Towson, Md., lab directed by Otto. It is building a tumor and tissue library along with corresponding information on the donor patients' conditions, treatments and health status. Researchers will use the resource to investigate how certain compromised cells respond to specific treatments. The early focus is on cancer research, but the concept can be applied to other disease families, such as cardiology.
The Mercy Cancer Center in Des Moines, Iowa, is one of eight CHI facilities contributing biospecimens to the repository. Dr. Richard Deming, medical director of that center and a principal investigator for the National Cancer Institute Community Cancer Centers Program, explained that certain markers in cancer cells hold clues about the characteristics of the cancer type and ideal treatment approaches. Collecting specimens from volumes of patients with different cancer cell characteristics — and pairing that information with details on the patients' response to certain treatments, he said, are "the first steps to know how tumors with certain fingerprints respond to specific treatments. Over the years . . . as we collect more specimens, we will learn more about best treatments."
This information also can help researchers to begin to develop a protocol for more personalized treatment plans to better target cancers from the onset of treatment, according to Deming.
But, no one hospital has access to the volume of specimens needed to build up a tumor library, and that's why collecting specimens from many CHI hospitals and grouping all that information together is so essential, Deming said. He noted that while the National Cancer Institute, many universities and commercial laboratories around the U.S. have developed small biospecimen repositories, there is no centralized, national repository.
Otto said the center is building its infrastructure and accumulating specimens before it begins looking into research investigations that may benefit from using the repository.
Opportunity to expand
CHI hopes to involve as many of its facilities as are interested in the institute's work. And, the institute plans to expand eventually beyond CHI facilities.
The system hopes that as it builds up a larger base, and gains increasing credibility in the research field, the centers will become self-sustaining. Currently, CHI is providing the bulk of the funding for the institute and its centers — the system has invested $55 million since 2007. But in time CHI hopes to attract other financing sources for its centers' work, including grants from private donors, governmental agencies and corporations.
Kashkin said that the ultimate goal is to improve the quality of care for patients. The institute, he said, "hopes to bring a culture of research to exist alongside the provision of care in the community setting."