Answering the Clinical Research Challenge in a Growing Health System
Authors: D. Whellan
Year: 2019

Clinical research in the United States is under siege. The number of clinical trials, whether measured as the number of trials performed, number of participants enrolled, or number of investigators, is declining sharply (1). Although the United States has the highest proportion of clinical trial sites in the world at 43%, the annual growth rate from 2006 to 2012 was negative (2). Several factors have converged to create an environment within the United States that does not promote clinical trial research (Table). Economic drivers, such as the cost of performing clinical trials, turn sponsors to other countries (3). Reductions in federal funding (4) have forced potential investigators to pursue clinical practice careers instead of dedicating time to research. Heightened regulatory requirements contribute to the rising cost of research and raise concerns about potential investigator liability (5). In addition, the changing practice of medicine and evolving reimbursement model place greater demands on clinician time and create a financial disincentive for participating in clinical trials (6). Recent findings, such as the aging and dwindling numbers of investigators (7), are the result of these macrotrends and threaten the ability of the United States to remain a leader in clinical research. Table. Barriers to Clinical Research at Academic Health Centers and Potential Solutions At the same time, changes in health care systems are exerting even more downward pressure on participation in clinical trials within academic medical centers. With the mandate of shared risk and population health created by Medicare and other third-party payers, health systems have been merging to better negotiate terms with payers, manage costs, and provide more comprehensive and higher-quality care (8). As academic medical centers join with community hospitals, clinical research tends to be deemphasized within the overall strategic plan. Academic culture is diluted as leadership teams merge and organizational priorities expand to include new partners. Compensation plans for providers are shifting from protecting efforts to pursue the academic mission to promoting clinical activity, because these models speak to all providers across the health system. As clinical practice grows within academic health systems, leadership often splits academic responsibilities from the clinical enterprise. The professional administration and chief medical officers have assumed the role of overseeing clinical practice, which traditionally was the purview of clinical department chairs based in medical schools. This dichotomy of academic and clinical functions is reflected in the flow of funds within organizations. In older models, chairs could easily shift dollars from clinical practice to support the academic mission, which generally requires subsidization (9). The desire of clinical practice leadership to support the academic mission is reduced as it becomes deemphasized by priorities and incentives for the enterprise. Implementing, maintaining, and growing clinical research in this environment is challenging. The organizational clinical research model needs to be both dynamic in its ability to grow with the organization and flexible enough to recognize the diversity of patients, practice environments, and investigators. Academic health systems also must remain committed to the core mission of research to advance the understanding of diseases and treatments that will improve the health of their patients. To achieve the goal of providing high-quality, cutting-edge, compliant, and ethical research, academic health systems must create effective organizational structures, promote participation of stakeholders, and support the research community. Because clinical research bridges both academic and clinical operations, it must be a component of strategic planning, operations, and budgetary consideration for the whole organization. A governance structure that includes a broad representation of research and clinical leadership, as well as policies that align all users within the health care system, provides the necessary framework. Balance is needed between a central administration that creates efficiency and consistent compliance with regulations and decentralized researchers across the health system in which clinical research is performed within the clinical practice. The establishment of a centralized resource for clinical research services, including grant administration, project management, regulatory support, and experienced clinical research personnel, is an effective way to increase the accessibility of research across departments, service lines, and clinical units. Every patient and provider should have the opportunity to participate in clinical research and should be supported by the central administration. Technology plays an important role in connecting persons involved in clinical research, particularly as health systems grow and become geographically dispersed. Although health care traditionally has been behind the technology curve (10), pressure from a business perspective and from federal mandates has pushed systems to adopt more innovative approaches, for both the clinical practice and research. Software systems to manage the aspects of clinical trials, including regulatory submissions, finances, and documentation, have proliferated across the market to address operational challenges. Extending concepts adopted from other industries, health systems have turned to social media to promote ongoing clinical trials; disseminate results; and create communities of patients, investigators, and research staff. Within these communities, researchers with common interests can advocate for specific research priorities. None of the organizational actions and investments will have an impact on clinical research unless the declining number of investigators is addressed. Providing operational support lowers barriers to participation but does not tackle the issue of redirecting efforts from clinical practice toward research. When provider time is being monitored closely, a counterbalance is required. In a growing academic health system, flexibility is needed in how research effort is recognized that accounts for the different priorities of investigators. Some institutions may consider incentivizing academic output through a point system that is tied to bonuses. Another option is to develop a system of research-based relative value units linked to research and academic activity. Any method needs to be transparent and linked to performance of high-quality, ethical research. The ongoing retreat from clinical research in the United States will have a lasting effect on our patients and communities. Many advances in health care that we enjoy today are the result of decades of American clinical research leadership. Without a doubt, the changing health care environment and wider societal and business trends are creating a challenge in this area. Academic health systems have a mandate to meet that challenge.