Networks of integrated, community-focused hospitals — let's call them health care systems — have a key role in clinical research. These large, somewhat eclectic entities serve rural as well as urban areas, may be for-profit or nonprofit, and interface with a variety of other health care entities. But one thing they have in common is a greatly untapped potential to provide research knowledge.
In the United States, research is largely concentrated in academic medical centers, and a gap remains between clinical research (which tends to beget more clinical research) and care. Vital techniques, interpretation and concepts can fall into the chasm between research and bedside.
Clinical research needs to be translated into action to have a positive effect on the cost, quality and efficiency of the health care system. To help bridge the gap and maximize the value of clinical research, health care systems should strengthen their in-house clinical research activities and consider a systematic, centralized approach.
Bridging the Gap between Research and Patient
The need for such strengthening is becoming increasingly urgent. As the U.S. population ages, chronic diseases will become more prevalent and system utilization will increase, leading to a growing demand for high-quality clinical research information that can be translated quickly into action that improves patient outcomes.
But even as the demand grows, the clinical research workforce is shrinking due to the lack of a core clinical research curriculum, which is leading to an inadequate base of qualified researchers who can translate current basic science discoveries into tangible health benefits. And that knowledge is not being disseminated evenly throughout the United States. Even when appropriate and updated guidelines are issued, they are not always followed. Practice-based research to validate the application of this knowledge is lacking. In short, change on many levels is needed to close the gap between research and practice.
Current Clinical Research Approaches
Since the Institute of Medicine issued its key reports on health care quality (To Err Is Human: Building a Safer Health System and Crossing the Quality Chasm: A New Health System for the 21st Century), the nation has begun to develop a health care system that measures and improves the quality of care. According to those reports, such efforts require a systematic approach for assessing which clinical approaches work and which do not.
The U.S. Food and Drug Administration recommends establishing a central clinical trials office within health care systems, bringing interrelated functions together under a single management structure. Benefits include integrating scientific review, contracting, budgeting, compliance, and education and training activities related to clinical trials, with established communications channels.
The Association of Academic Health Centers has outlined two approaches taken by institutions seeking to centralize such functions. The first builds on existing structures, expanding the remit of administrative offices and entities as needed. The other builds a new enterprise that would offer more benefits and services and thus outperform the existing entities. Researchers presumably would migrate to the more efficient approach, making the existing structure redundant.
The centralized approach fits in well with the increasing expectation that health care leaders will refer to research evidence in making policy and practice decisions, as noted on the Agency for Healthcare Research and Quality's National Guideline Clearinghouse website. America's Health Insurance Plans has said that its member organizations are "strongly committed to advancing an evidence-based health care system in which information generated through clinical research is quickly and effectively translated into everyday medical practice." They are also committed to using available evidence to make appropriate decisions about coverage.
Many insurance plans are employing pay-for-performance strategies, and government reimbursement rates are becoming tied to quality — making evidence critical. Fortunately, studies on evidence-based practices in diverse health care settings have helped build an empirical foundation of bench research to patient bedside and in turn will aid in expanding research discovery to the specific populations of your health care system.
Closing the Bench-to-Bedside Gap
The mere existence of care protocols is not enough. Focused management controls or checkpoints designed to maintain quality standards throughout the clinical trial process often are missing, even in the most highly regarded health care systems. Operations rarely are defined or administered through systemwide policies or procedures; instead, over time, individual offices take on the execution of various functions. The lack of systematic, timely controls and compliance helps lead to an ad hoc approach in which appropriate reporting is almost an afterthought.
There must be a strategy that balances external economic and quality demands. Creating centralized processes for clinical research endeavors within the health care system might be the best approach.
Better Evidence Makes a System More Competitive
It is clear that research evidence should play a role in clinical decision-making. The critical question is how health care systems balance this need with the consumer demands and preferences of today's health care marketplace.
Patients continue to seek second opinions, elect alternative therapies and choose whether to adhere to prescribed treatment. A rising tide of information enabled by advances in technology has increased patients' ability to be informed about disease symptoms, the latest treatments and cutting-edge medical care. Payers and government are aligning payments to outcomes and recognizing centers of excellence for reimbursement bonuses.
To compete in the marketplace, hospitals must offer services that are innovative and meet the standards of the Quality and Efficiency of Care clause of the Patient Protection and Affordable Care Act as well as payer guidelines while responding to patient preferences. The effective development and use of clinical research can aid in that task.
The modern-day health care system is the ideal setting to advance clinical research and translate its results into clinical practice. A systematic, centralized approach can help transform clinical research results into population-centered health care and produce reliable, valid research for the patient population. The result is cost-effective and resource-efficient care — and improved health outcomes.
Jim Moran is an executive director in St. Louis; Erika Stevens is a senior manager in New York City; and Brian Chappell is on staff in Austin, Texas, all at Advisory Health Care, Ernst & Young LLP. The views expressed herein are those of the authors and do not necessarily reflect the views of Ernst & Young LLP.