Role of Personalized Medicine Research

No two people are exactly alike, and medical therapy may not work exactly alike in any two people. There are numerous factors that influence the occurrence of a condition and response to treatment. The more information a health care professional and patient have about factors that may influence occurrence and response, the better equipped they are to make informed health care choices. The goal of personalized medicine research is to provide this type of evidenced-based information. VA Research is conducting personalized medicine research by exploring the effects of genes and genetic variations, and conducting studies and examining literature to determine which options work best for which group of patients. By translating research findings into useful information for both providers and patients, VA Research supports Veteran centered care and service delivery across the spectrum of disease prevention, diagnosis, treatment, and monitoring. Armed with evidence-based information that is accurate, comprehensive, and understandable, VA health care providers can partner with their patients in making health care decisions that best match the patient's needs. VA is singularly equipped to conduct personalized medicine research. Among VA's standout resources are its world-class investigators—many of whom also provide patient care—and its unmatched system of electronic medical records. The computerized system securely stores detailed information about Veterans' health histories and outcomes, in a format that allows sophisticated analysis of data. Matching medical approaches with each patient's needs requires broad-scale innovation and a system that facilitates translation of research findings into practice. Among the areas of personalized medicine research that represent VA's forward-looking investigative approaches are genomic medicine research and comparative effectiveness studies.

Genomics Research

Genomics—the study of people's genetic makeup—is essential to optimizing Veterans' health in the 21st century. The more VA researchers learn about the effects of genes and genetic variations, the better health care providers will be able to customize care based on an individual's genetic composition. New discoveries in the area of genomics could improve prevention, screening, and diagnosis and point toward more effective treatments. Genomic medicine could make it possible to predict a person's risk for a health condition or to anticipate a patient's response to a drug. Already, VA research has provided tremendous insights into the biology of complex diseases such as diabetes and cancer through genetic analysis. Genomics-based approaches in use at VA include genetic tests to help diagnose breast, colon, and other types of cancer and to confirm the diagnosis of hemochromatosis-a hereditary condition in which iron builds up in the body. VA's pioneering researchers continue to unravel the mysteries of genomics to understand how genes affect our health and how this knowledge can improve health care for Veterans and all Americans. VA research projects are looking at genes' role in amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig's disease; bipolar disorder and schizophrenia; and posttraumatic stress disorder (PTSD) and other post-deployment adjustment disorders, such as depression. VA Research is taking advantage of evolving technologies to advance its Genomic Medicine Program. For example, VA is using transforming technologies to refine methods for extracting information from the electronic medical record and make it securely available for studies conducted under the Health Care Informatics Research Initiative. Health care informatics research, which integrates communications technology with biomedical knowledge and/or patient information, is expected to have many applications.

Comparative Effectiveness Research

VA is a leader in comparative effectiveness research (CER)—head-to-head studies that help clarify which among two or more health interventions works better for a given health condition in a certain group of patients. Some of these trials compare one drug to another, while others compare different approaches such as surgery versus an accepted drug therapy, or different ways to deliver care to patients. By testing how drugs or other medical approaches stack up against each other, VA's CER is helping health care professionals answer the crucial question, "Which health care approach will benefit my patient the most?" and represents an important step toward personalizing care. VA's groundbreaking CER studies include:

• Angioplasty plus stenting in stable coronary artery disease.
  A major U.S.-Canadian trial found that a commonly used treatment called percutaneous coronary intervention (PCI) did little to improve outcomes in patients with stable coronary artery disease who also received optimal drug therapy and underwent lifestyle changes.
• Intensive therapy to support kidney function.
  VA researchers, in collaboration with NIH investigators, showed that delivering more intensive therapy for acute kidney failure—for example, dialysis six times a week instead of three—did not benefit patients, compared to conventional treatment.
• Prolonged-exposure therapy to treat PTSD.
  VA researchers showed that prolonged-exposure therapy, in which therapists help patients recall their trauma memories under controlled conditions, helped women reduce their PTSD symptoms more than emotional support and counseling focused on current problems.
• Two drugs for normalizing heart rhythm.
  VA researchers compared two drugs, amiodarone and sotalol, to determine which is better at correcting a common heart rhythmabnormality called atrial fibrillation. The drugs worked equally to achieve a normal heartbeat initially, but amiodarone was better at maintaining a regular heartbeat.

Keeping VA at the Forefront of Personalized Medicine Research

VA Research is developing tools to support personalized decisions across the spectrum of Veterans' health care needs.

Following are examples of resulting advances in personalization of VA care:

Hypertension treatment: Which drug choice is optimal for this patient? High blood pressure affects tens of millions of Americans and can substantially increase risk for heart disease and stroke. To help guide decision-making by hypertension care providers, VA Research is developing a system that can take into account not only complex treatment guidelines, but also patient specific information from the electronic medical record.

Advanced Prosthetics: Which prosthesis best suits this patient's lifestyle? With the active lifestyle demands of the current Veteran population and the increasing number of female Veterans, there is a growing need for lighter, better-fitting, more functional prosthetic limbs. VA researchers and engineers have made significant advances in the area of prosthetics, and are studying how to best match prosthetic devices to each Veteran's unique demands.

Diabetes Care: Which intervention will benefit this patient the most? For some people with diabetes, exercise and proper diet may be enough to avoid complications associated with the common condition; for others, oral medications or insulin will be the best approach to keep blood glucose within a normal range. With information from a patient's electronic medical record—about the person's age and other chronic conditions, for example—and with the evidence-based information provided by VA Research, clinicians can present appropriate treatment options to each patient, and can educate those at risk about individualized prevention strategies.

Veterans' Rights as Paramount

VA's pioneering personalized medicine research, including effectiveness studies, is possible because the Veterans Health Administration provides care for millions of Veterans, many of whom generously volunteer to participate in health care research.

Protecting Veterans' rights is the highest priority in all VA research efforts, and important safeguards are in place to protect the rights and welfare of research participants.

Among these safeguards are specific measures to protect the confidentiality of Veterans' genetic and other personal health information. These include strict rules for collecting DNA samples for VA research. To maintain privacy, Veterans' samples are labeled with a code that does not contain any personal information (such as name, address, Social Security number) before they are stored for analysis. Researchers who are granted access to Veterans' samples are not given any information that would identify who donated them. A "key" that links the code to the Veteran's identity is maintained in an encrypted file that only a limited number of authorized staff can access. VA human rights committees are in place that focuses exclusively on preserving research participants' rights.

Key Research Programs for Personalized Medicine

Because of the multidisciplinary nature of health research, all of VA's research services work collaboratively in investigative efforts. VA programs with a central role in personalized medicine research include:

Cooperative Studies Program

The Cooperative Studies Program (CSP) is renowned for its large-scale, innovative clinical trials—many of them comparative effectiveness studies—on a wide range of critical health topics such as cancer, heart disease, diabetes, infectious diseases, and mental health conditions.

Evidence-based Synthesis Program

To tackle the tough research questions of particular importance to Veterans and Veterans Health Administration policy-makers, researchers with VA's Evidence-based Synthesis Program (ESP) rigorously examine existing research findings. They carefully evaluate the data's quality, thoroughness, and relevance to VA and produce a report detailing what is known about a health topic. By presenting the evidence about treatment options as they have been tested in defined groups of patients, the syntheses can guide VA clinicians and their patients as they make personalized care decisions.

QUERI

VA's Quality Enhancement Research Initiative (QUERI) program was developed to advance Veterans' health care by facilitating the adoption of new treatments, tests, and models of care—based on evidence from research—into routine clinical practice. QUERI focuses on conditions that are common among Veterans and that place a high burden on patients, family members, and the VA health care system. The program helps keep providers and patients informed about research findings in these areas so they can make the most well-informed, personalized medical care decisions.