Question

Identify at least one barrier that relates to challenges with population health. Consider how you could employ translational research to potentially overcome this barrier. Identify the best type of translational research to address this barrier, and provide rationale for the type you have chosen. What would be the challenges of using this type? What strategies would you employ to provide an understanding of your chosen type of translational research and to gather collaborative support?

Answer 1

Translational research has tremendous potential as a tool to reduce health disparities in the United States, but a lack of common understanding about the scope of this dynamic, multidisciplinary approach to research has limited its use. The term “translational research” is often associated with the phrase “bench to bedside,” but the expedited movement of biomedical advances from the laboratory to clinical trials is only the first phase of the translational process. The second phase of translation, wherein innovations are moved from the bedside to real-world practice, is equally important, but it receives far less attention. Due in part to this imbalance, tremendous amounts of money and effort are spent expanding the boundaries of understanding and investigating the molecular underpinnings of disease and illness, while far fewer resources are devoted to improving the mechanisms by which those advances will be used to actually improve health outcomes. To foster awareness of the complete translational process and understanding of its value, we have developed two complementary models that provide a unifying conceptual framework for translational research. Specifically, these models integrate many elements of the National Institutes of Health roadmap for the future of medical research and provide a salient conceptualization of how a wide range of research endeavors from different disciplines can be used harmoniously to make progress toward achieving two overarching goals of Healthy People 2010—increasing the quality and years of healthy life and eliminating health disparities.

In the field of health research, “translation” is the process through which breakthroughs in science are used to improve human health.1 Unfortunately, many people in both the public and professional spheres perceive translational research simply as a linkage of biomedical and clinical research that expedites the transfer of scientific innovations from laboratories to clinical trials. This aspect of translation, frequently associated with the axiom “bench to bedside,” is a key element of the translational process (phase 1 research translation or T1), but another component is equally important—the transition from the bedside to real-world practice (phase 2 research translation or T2).2 The integration of these two phases enhances the tremendous potential of translational research as an approach to help eliminate health disparities; however, phase 2 research translation has not gained mainstream acceptance as a domain of equal scientific value. Several innovative organizations have taken the lead in promoting the more evolved purview of translational research (eg, the National Institute of Diabetes and Digestive and Kidney Diseases, 3 the National Cancer Institute,4 and the National Institute of Environmental Health Sciences5), but this perspective remains limited, due in part to the lack of a more detailed, unified conceptual framework.

Addressing the real-world issues that fall under the domain of phase 2 research translation is vital to eliminate health disparities because most of the inter-group variance in reductions in morbidity and mortality that can be attributed to newly developed treatments relates to the delivery of interventions at the provider-patient level, rather than differential pharmacodynamic effects of the treatments themselves. Even though an ever-increasing amount of resources are spent every year to discover new means of treating diseases, far less energy is devoted to improving the mechanisms by which these treatments will be used to benefit people who are in need.6 The expedited conveyance of new discoveries to clinical practice (and the improved delivery of existing therapies) is of particular importance to high-risk populations because despite their great need for new health-related insights and resources, these populations are usually the least likely to reap the benefit of medical advances brought about by our booming research enterprise.7 Presented below are two complementary conceptual models that show how translational research can be used as a framework for leveraging advances in clinical and biomedical research to reduce and/or eliminate health disparities.

The health disparities model illustrates the perpetual flow of interdisciplinary collaboration that arises from the use of advances in biomedicine to reduce health disparities. The translational research model expounds upon this framework and provides a unifying structure that delineates the scope of the translational research paradigm. Both models are derived from established frameworks that have been adapted to provide a robust, disease-nonspecific understanding of the translational research process. The models integrate many of the elements of the NIH roadmap for the future of medical research8, 9 and provide a salient conceptualization of how a wide range of research endeavors from different disciplines can be used harmoniously to make progress toward achieving two overarching goals of Healthy People 2010—increasing the quality and years of healthy life and eliminating health disparities.10

The Models

The first model illustrates a framework for advancing health disparities research (Figure 1). The model presents three basic sequential phases, or generations, of health disparities research: 1) detecting disparities; 2) examining their causes and developing interventions; and 3) implementing those interventions and monitoring outcomes specific to health disparities. The process is repeated until no discernable differences in disease outcomes exist. The primary difference between this framework and existing frameworks is that it conceptualizes health disparities research as a cyclical process. This change might be perceived as a minor semantic alteration, but it constitutes a significant modification in the interpretation of and approach to health disparities research. The model shows that even after the development of successful therapeutic interventions, it is still necessary to identify and assess systematic barriers to their adoption that may further perpetuate the initially identified disparities. Envisioning research as a cyclical, collaborative process creates a framework for accountability that ensures scientific breakthroughs contribute to improvements in health outcomes on the population level and consequently leads to the elimination of health disparities.

The second conceptual model (Figure 2) is a more detailed illustration of the many elements involved in the translational research process. It builds on other recent conceptualizations of the translational research and depicts the same processes detailing the multitude of interdisciplinary linkages needed to leverage advances in scientific knowledge to improve the health of human populations. This model bears particular relevance to health disparities research because it illustrates the integral role of structured approaches to addressing environment-and system-specific (community-level) factors, thus emphasizing the importance of real-world considerations in the translational research process

Our framework is oriented toward the health services approach to facilitate the development and delivery of therapeutic treatments, but the framework also integrates the public health perspective16 and provides an opportunity for consideration of community-level factors that have a significant impact on health. The nontraditional graphic representation of the environment depicted in the model illustrates that some elements of the research process operate largely or entirely free of the influence of real-world variables. Consequently, in order to fully translate biomedical advances into improvements in the health of a population, interdisciplinary collaboration that involves research in the uncontrolled conditions of the real world is essential—especially for addressing health disparities.

From the Community

A vital but often overlooked first step in all health disparities research is clearly identifying the disparity and the root causes. For decades, published health data have provided evidence that racial and ethnic minorities are often disproportionately affected by many diseases and illnesses. Nonetheless, in communities where many people do not have a regular source of care, more research is needed to ascertain the true incidence and prevalence of non-acute diseases and illnesses. More importantly, not all racial and ethnic minority groups are homogenous. Some risk factors are more strongly linked to race and sex, but most risk factors are more closely tied to socioeconomic status, acculturation, and environment.

Public Health Research

Community Engagement It is important to be actively engaged with the community before initiating research aimed at curbing most racial and ethnic health disparities. Most minority groups have some level of mistrust for researchers who are strangers in their communities, and some also have specific attitudes and beliefs that affect their willingness to participate in clinical research or to contribute to biomedical research.1For this reason, research teams must include individuals who have a rapport with the community and have established a relationship built on trust and mutual respect. Collaboration with researchers who have experience working with community-based organizations will help facilitate adherence to the principles of community-based participatory research (CBPR) throughout the translational process.

Epidemiologic Assessment Epidemiologic assessment is intended to gather information pertaining to: characteristics of at-risk populations and community-specific etiology of health phenomena. From a practical standpoint, it is not essential for a new epidemiologic assessment to be the impetus for all translational research, but for health disparities research, researchers must be able to properly identify populations that are disproportionately affected by specific diseases or conditions. Race and ethnicity are often used as surrogate identifiers for at risk populations, but these abstract groupings often mask the underlying factors that define the group at risk.19 For example, even though collectively, “Latinos” may exhibit normal or even low rates of some adverse health outcomes, there may be drastic differences in rates between migrant farm workers from Central America and urban-dwelling second-generation Americans of Puerto Rican descent. Establishing more accurate estimates of the incidence and prevalence of diseases in minority populations will require further study of sociocultural and environmental risk factors, the development of new diagnostic techniques and biomarkers, and improved tactics and resources to increase screenings.

To the Bench

Cutting-edge biomedical research that currently takes place in isolation can play a major role in curbing health disparities if incorporated into a translational research approach. Biomedical research can be initiated independent of population-specific inquiries about health disparities, but before advances in biomedicine can become the cornerstone of efforts to eliminate health disparities, the target population must be given the opportunity to provide input in the research process, or they may not be receptive of new findings, regardless of their validity. This is particularly true in the later stages of bench research, when it may become necessary to use blood or tissue samples. In some instances, researchers who have entered into this stage of work without the consent and support of the community have encountered significant obstacles.

Therapeutic Discovery Research

Therapeutic discovery research (which can include the development of diagnostic techniques as well as therapeutic treatments) is one of the main activities involved in phase I research translation (T1). This area of research also involves substantial public-private partnership as academic and industry investments merge.

To the Bedside

Traditional Clinical Trials Therapeutic discovery research culminates in the initiation of exploratory clinical research. Randomized clinical trials have long been considered the gold standard for experimental medical research. These studies are vital for determining the independent effect of specific treatments on health outcomes. Unfortunately, these efficacy studies are often narrowly focused and have restrictive inclusion and exclusion criteria. Even though traditional clinical trials examine interactions that take place under conditions that are more dynamic than those investigated in biomedical research, these conditions are inherently more static than those encountered in the real world, so traditional clinical research trials are not necessarily a harbinger of real-world effectiveness.

Practical Clinical Trials In contrast to traditional clinical trials, practical trials incorporate environmental factors and are designed to assess the effectiveness of interventions in real-world conditions.practical trials also differ from traditional clinical trials in that they only compare interventions amenable to implementation in broad community contexts, they enroll diverse study populations, they recruit from a variety of settings, and they measure a broad range of relevant health outcomes. For these reasons, practical trials can be used to directly inform evidence-based practice.