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Recent advances in genetic research and health information technology have raised hopes that healthcare providers might someday be able to offer patients intensely individualized care based on their unique genetic makeup and medical history. However, a broader transformation of our healthcare system is needed if future generations are to enjoy the potential benefits of personalized care. At the Department of Health and Human Services (HHS), we are laying the foundation for the needed transformation through our Initiative on Personalized Health Care, which directs the Department's work toward developing a healthcare system based on knowledge of an individual's unique biology. The key contributing characteristics of a healthcare system that supports this goal include: personalized medical decision–making to meet individual needs, prediction of disease predispositions and health outcomes, prevention of disease and pre–emption of processes that result in disease, and patient participation and consumer empowerment in shared decision–making.

The concept of personalized healthcare emphasizes the use of evidence-based approaches to accommodate individual differences in disease risk and the likelihood of beneficial outcomes to interventions. Although this does not suggest that each person will have custom-designed drugs to suit his or her needs, it incorporates the understanding that biologic uniqueness and patient-specific preferences are important contributing factors to differences in health outcomes. In the broader context of a healthcare system, we see elements emerging that will support the mass customization of services to accommodate patient-specific preferences and biologic determinants of health and disease.

Recently, HHS published its first report1 on personalized healthcare. The document summarizes current programs and initiatives shaping federal efforts to support patient-centric healthcare practices. It comes as many institutions (state and local government health agencies, health advocacy organizations, professional organizations, and industry) are looking for ways to meet the individualized needs of patients. This report outlines the first steps in establishing the infrastructure and policy approaches that will transform the concepts of healthcare to support individualized healthcare practices. We believe that our report may enable others to integrate the work of the HHS with their own, thereby leveraging the progress being made on many fronts.

Work on cancer is of special importance to the individualization of care. Cancer care has long been a model for the treatment of many other diseases. Today, emerging facets of cancer care illustrate the growing importance of patient-centric approaches based on advances in biologic knowledge. The hallmarks of this emerging model for patient-centric cancer care include a wide-spectrum approach to treating related biologic conditions, the advent of therapies tailored to specific molecular determinants, an increasing understanding of diversity in health outcomes, and estimations of risk from genetic and environmental factors. These hallmarks should inform the development of patient-centric approaches to the treatment of other diseases.

Setting the Stage for Personalized Healthcare

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  2. Setting the Stage for Personalized Healthcare
  3. REFERENCE

Personalized healthcare seeks to use our newfound knowledge of biologic differences in humans to improve health outcomes through enhanced prevention, pre–emption, and prediction. Recent years have witnessed the accelerating discovery of biologic mechanisms linking cancer to genetic aberrations and environmental factors. We are now witnessing early efforts to develop genetic maps of cancer, using breakthrough technologies that have reduced months and years of analytic work to literally hours. However, as this research capacity continues to build, new challenges are emerging. The ability to assemble massive amounts of biologic data will require new analytic capabilities to digest the data and generate knowledge.

In response, the cancer community has laid the foundation of a national cancer bioinformatics grid to facilitate scientific communication and enhance innovation through streamlined discovery and technology development. It has also begun building pathways to connect scientific information in support of healthcare practice, and is developing standards and data architecture along with health information exchange capabilities. New approaches to developing pharmaceuticals and modifying cancer processes are unfolding through the use of imaging technologies, computer modeling, and innovative clinical trial designs. Each of these initiatives is helping to build the scientific base for individualized approaches to cancer care.

Despite this progress, many vexing challenges lie ahead in clinical intervention development programs that strive to accommodate diverse approaches with limited financial resources. Our report on personalized healthcare highlights several transformative approaches across the HHS that are beginning to set the stage for patient-oriented care plans. In the past several years, the US Food and Drug Administration (FDA) has been modernizing approaches for clinical development through its Critical Path initiative. The FDA is collaborating with industry and academic institutions to develop more precise measures of patient response to new interventions. This is enabling better predictive capabilities and yielding greater amounts of information for new medical product development. The safety of medical products continues to be a primary goal, to assure that the well-being of the patient is not compromised.

The National Institutes of Health's Roadmap for Medical Research is advancing new initiatives to increase our understanding of the biologic basis of cancer. The NIH is also revitalizing the national clinical translational science infrastructure to find new ways to turn advances in research into patient-oriented applications. The cross-agency Genes and Environment Initiative, building on a backbone of the genetic information relevant to cancer, is providing new opportunities with which to understand risk-based approaches in assessing environmental associations with cancer occurrence. Innovative research has also produced novel concepts for prevention, which have led to recent successes in vaccine development for cancer interventions. Advances in preventing certain types of cervical cancer are evidence of continued progress.

In addition, population-based, genome-wide association studies are becoming part of the research landscape, and will soon yield new opportunities to understand cancer risk as well as new pathways for arresting the disease at its earliest stages. The Agency for Healthcare Research and Quality is working with healthcare delivery systems to evaluate the clinical effectiveness and quality measures of cancer care. Initiatives supported by the Centers for Disease Control and Prevention are applying genetic technologies in risk determination, screening, and prevention strategies to community-based research. These and other innovative programs and initiatives are bringing together elements to form the foundation for a healthcare system that individualizes interventions for cancer.

Remarkable advances have been made in recent years in developing target-specific therapies and using advanced technologies to more accurately characterize cancer and detect the presence of cancer before symptoms appear. Although much work lies ahead, the direction of this work appears clear, and the pathways for early detection and, ultimately, prevention are becoming more definable.

These new approaches to detecting and treating cancer could be contributing to the recent downward trend in cancer cases. Over the past several years, the mortality rate for many forms of cancer has decreased at a quickening pace, and the number of cancer survivors continues to grow. Of course, we have much farther to go. Despite the progress that has been made, significant disparities remain among some populations of Americans. Other data (eg, rising rates of morbid obesity, demographic shifts, and the overall aging of the population) pose other challenges. In an effort to confront them, the National Cancer Institute has launched a pilot program to study new ways for community cancer centers to deliver the benefits of the latest science to more Americans closer to home.

The Path Forward to Patient-centric Cancer Care

There is still much for us to do to make individualized care universally available to cancer patients. The programs and initiatives in our recent HHS report can help maximize opportunities for improving patient-centric practices. However, maximizing research opportunities requires broader changes in our health system, which can only come about through committed efforts by many stakeholders. Fortunately, community-based initiatives all over America are already bringing together providers, insurers, employers, research institutions, and consumer groups to optimize exchange of health information and provide more patient-centric healthcare.

Patient-centric cancer care requires an information system that enables consumers and providers to easily exchange health information. Efforts are currently underway at the federal, regional, and local levels to establish the infrastructure, policies, and incentives supporting the secure exchange of personal health information. We are working with stakeholders to create standards for interoperable health information systems. We are also working to encourage the adoption of interoperable systems by providers. After their adoption, we will need to find ways to connect clinical research with the healthcare delivery system so that research results can be quickly translated into clinical practice. Throughout our health information technology initiatives, we are taking steps to enhance consumer use of research and medical information resources to improve the quality of information and timeliness of translating research evidence into clinical practice. In addition, consumers will use health portals to access their health records, manage the information about their healthcare needs, and engage in active exchanges with health professionals to guide their care plans.

Along with enhancing consumer interfaces for health information exchange, we will also need to continue to ensure that we have adequate policies to secure and protect patient information. The exchange of genetic test data and clinical information must be accomplished in ways that maintain patient trust. Privacy protections and prohibitions on discrimination on the basis of genetic predisposition are essential components of personalized healthcare. An important addition toward this was added on May 21, 2008, when President Bush signed into law new federal protections provided by the Genetic Information Non-discrimination Act of 2008 (GINA).

Another key is the pathway we develop for using clinical evidence regarding new technologies and medical products. Although some clinical information can be accessed currently through claims and health services utilization data, these alone will not provide the patient-specific types of information required to support individualized health recommendations. Additional tools are needed to incorporate additional clinical information into the healthcare decision-making process. Answers to critical healthcare questions should be available on demand to both providers and patients. Patient empowerment has been a force for change in cancer care for many years. To accommodate the increasing complexity of health information, patients will need additional tools to understand their own care options. New approaches are also needed to keep health professionals abreast of new knowledge in cancer management strategies.

Personalized cancer care may ultimately be defined by comprehensive risk-management strategies that begin early in life, based on early assessments of a person's likelihood of developing cancer. Designing early intervention programs based on individually identified biologic parameters may yield a new horizon for preventive care services. We need to make early detection and prevention a hallmark of healthcare in the future.

Consumers should realize that there are many steps yet to be taken on the pathways toward a healthcare system that they will encounter as personalized by receiving the right intervention, for the right healthcare indication, at the right time–everytime. To achieve better quality of cancer care through personalized approaches, consumers will need to actively engage with researchers and medical professionals to better understand and manage their cancer risk through medical practices, health technologies, and lifestyle approaches that are scientifically sound and evidence-based. Through many facets of personalized healthcare delivery, each patient's emotional and psychologic needs will be actively engaged by user-friendly information services, social networking support, and accommodations to support active lifestyles in the home and workplace.

As we look to the future of all aspects of the discovery, development, and delivery continuum of cancer care, we see the development of a system to understand and meet each patient's specific healthcare needs as the focus of our combined work. When we have accomplished that, we truly will have made great strides in enhancing cancer care through personalized medicine.

REFERENCE

  1. Top of page
  2. Setting the Stage for Personalized Healthcare
  3. REFERENCE