Most patients in the United States are treated in community hospitals and physician practices, a trend that could grow under the Affordable Care Act. By contrast, most life sciences research in the United States takes place at academic institutions, not at smaller hospitals. But community hospitals can do more to support research and give patients an opportunity to participate.
Conducting research can enable hospitals to offer cutting-edge treatments to their patients and to build a reputation for innovation that attracts forward-thinking clinicians. Hospitals known for their research often attract more patients who want to incorporate the latest medical thought and the most effective therapies into their care. Participating in research enhances a hospital’s image as a local center of excellence. It can also attract federal and industry funding.
Precision Medicine Initiative
In the past several years, the Federal Drug Administration and the National Institutes of Health have recognized the importance of broader patient engagement in the community health care setting for various research studies. The Precision Medicine Initiative announced by the White House in January 2015, in fact, counts on community hospital participation. Funded for the first time in fiscal 2016, it hinges on the recruitment and follow-up of 1 million or more people throughout the United States who will allow their medical data and biospecimen and lifestyle information to be collected and used for research.
This massive cohort will be followed to gain insights into a range of important health care questions. Data from such a broad segment of society will help researchers correlate genomics and environmental factors with disease onsets and progression and determine the most effective options to prevent disease and improve outcomes.
A key requirement of the PMI is to “ensure that people historically underrepresented in biomedical research are included in sufficient numbers to allow robust inferences in these groups.” Often, this means involving patients in community hospitals.
Barriers to participation
Many health care organizations, however, struggle to balance research engagement with their core mission of providing patient care. Nonacademic medical centers face a number of roadblocks, including concerns about increasing staff workloads, disrupting work practices and research ethics. Additionally, participation in research requires an understanding of research regulations, including requirements of the FDA, the Office for Human Research Protections and the Health Insurance Portability and Accountability Act.
Community hospitals can easily overcome many of these barriers by ensuring that research activities adhere as closely as possible to existing hospital workflows, thus minimizing any deviations from standard practices for hospital personnel and patients. In addition, hospitals can now apply various information technology approaches to their electronic health records systems.
A different way to participate
Community hospitals can get involved in life sciences research at both the discovery and the clinical stages. While most hospitals think of research activities as clinical trials, in the era of precision medicine and the drive toward improved outcomes, there are many other ways hospitals can give their patients a chance to contribute to medical advances. For example, collecting biological specimens (such as blood, urine, tissue and saliva) with associated data is a valuable contribution to many research studies.
The life sciences industry, academic institutions and the federal government, particularly the National Institutes of Health, have all invested heavily in biospecimen resources through federal grants and contracts involving both academic medical centers and community hospitals. For example, the Collaborative Human Tissue Network, funded by the National Cancer Institute, had more than 100 hospitals over the course of 20-plus years provide specimens to thousands of researchers. Contributing institutions have included academic medical centers like the University of Pennsylvania and Vanderbilt as well as smaller community hospitals.
In another example, the Massachusetts Hospital Association has partnered with a local startup to use new technologies to bridge the gap between community hospitals and academic and private researchers, thereby accelerating work that advances precision medicine. In this case, hospitals automatically collect data from the electronic health records of consenting patients and ensure that specimen collection corresponds with existing hospital practices.
Patients, especially those with a personal interest in medical advances, increasingly are asking how they can contribute to research. Many community hospitals now participate in research efforts based on requests from their patients. But privacy and patient consent remain fundamental. Patients should have the ability to participate or to decline. National data show that a large majority of patients participate in research when presented with the opportunity, and they typically report a positive experience — especially if they can take part in an efficient, minimally intrusive manner.
With the move toward personalized medicine, many hospitals need to be prepared for future research and patient care needs. Community hospitals are in a position to enable more patients to choose to participate in research, even if they are not being treated at a major academic research center. The ultimate goal is to establish and nurture collaboration between patients, hospitals and life sciences researchers to foster rapid improvements in care.
Kate Torchilin, Ph.D., MBA, is the CEO of Novaseek Research LLC in Cambridge, Mass.