ARRA and You (Part IVb): Challenge Grant Research Priorities. Currently, science administrators at NIH are allocating grant funds favoring proposals that have a high impact in biomedical or behavioral science and/or public health. Invariably, the 15 areas of priority that NIH has identified will influence the heath sector for years, so I present and discuss them around the nature of this influence.

1. I’ll address Behavior, Behavioral Change and Prevention research first, not only because it doesn’t fit neatly into the categories
   

   pdf available at www.jgi.doe.gov/education/posters.html

   that follow, but also because prevention is the beginning of health care. The question: Which has the greatest impact on health and disease? Nature or nurture? Inspires an argument that may be as old as time, itself. (Okay, I exaggerate, but only a little). As scientist have forged ahead making great strides in their understanding of nature through the sequencing of the entire human genome and the burgeoning discipline of genomics which has sprung forth as a result. They continue to struggle to elucidate the factors that influence behavior. Since the main diseases that plague us today (think heart disease, diabetes and cancer) are exacerbated by our behavior, this path of inquiry is truly worthy. The aim of this research is to better understand the factors that influence behavior, as well as the methods that have the most robust impact, changing behaviors to those that promote health and prevent disease. To date, prevention is still the most efficient and cost-effective option for alleviating the burden of suffering and disability brought on by disease.

Prevention through biomedical interventions has progressed well through this first decade of the new century. In fact, the next six research disciplines operate in concert. I believe the application of these cutting-edge 21st century technologies will transform the way we diagnose and treat disease bringing them to a personal and molecular level.

1. Let’s turn our attention to those highly debated Stem Cells. They
   

   Colour-enhanced scanning electron micrograph by Annie Cavanagh and Dave McCarthy. Winner of 2006 Biomedical Image Award (Wellcome Trust Medical Photographic Library)

   are simple, undifferentiated cells in the embryo or adult that have the potential to become any specialized cell in a living organism under the chemical influence of specific compounds and hormones. The aim of this research is to better understand the abnormal structure or function that causes disease. Cells with normal structure and function can be generated to replace diseased cells, through the process of culturing or growing them in the laboratory.

2. The area of Genomics aims to examine the entire DNA sequence (the instruction book, if you will, of all life processes) from the number of genes in a living organism to the function of specific genes. The goal is to see how they interact with one another and influence the biological processes of the body as a whole. Ultimately, genomics examines this genetic information to determine biological markers predisposing an individual to disease.
3. The aim of Biomarker Discovery and Validation research is to identify biomarkers (measurable biological molecules found in body fluids such as blood, or tissues that serve as a sign of a normal or abnormal biological processes). The presence or absence of a biomarker indicates a specific disease or response to a treatment for a disease.
4. The scientists at the McGowan Institute of Regenerative Medicine eloquently define regenerative medicine as “a new way of treating injuries and diseases that uses specially-grown tissues and cells (including stem cells), laboratory-made compounds, and artificial organs.” The aim of research in regenerative medicine is to examine these “approaches for ways to amplify the natural healing process in the places it’s needed most, or take over the function of a permanently damaged organ.”
5. The aim of research involving Smart Biomaterials and Theranostics (a term which combines the medical activities of diagnosis and therapy) is to elucidate the process of diagnostic therapy for individual patients. It involves testing them for possible reactions to a new medication and tailoring the treatment for the patient based on those test results. According to Daniel G. Anderson, a research scientist from MIT “such smart biomaterials are revolutionizing the design of medical devices and drug delivery systems. Gone are the days when medical devices had to be manufactured from off-the-shelf materials.”
6. Enabling Technologies are new technologies such as rapid point-of-care genotyping, computational and statistical methods for DNA sequencing and epigenetic molecules, that enhance the capabilities and performance of biomedical research.  The aim of this research is to use these technologies to improve diagnosis and treatment of disease.

These next five disciplines of research operate to improve the biomedical and clinical research enterprise overall.  Specifically, information technology and these older research methodologies will combine to increase health care system efficiency.

1. Research of Information Technology for Processing Health Care Data aims to make patient health care data readily available to providers in the health care setting enabling them to provide safe and appropriate medical care.
2. Translational Science aims to optimize the process that moves biomedical research findings discovered in the lab to a clinical setting where they are used safely and ethically to further translate those research results into a practical application for patients and communities that need them.
3. The aim of Clinical Research is to determine the safety and effectiveness of medications, medical devices and medical diagnostic interventions.  It generally relates to the entire research life of a chemical compound or device from its initial development in basic research through its final testing in the four phases of human clinical trials.
4. By Enhancing Clinical Trials (which are a part of the broader Clinical Research discipline), the aim is to use pre-defined protocols to measure the results of medical interventions in assigned patient groups or to measure the results observed in defined patient groups.
5. Comparative Effectiveness Research as defined in a Congressional Budget Office study aims to ensure that interventions used in a clinical setting are indeed the most effective for patients.  This involves research comparing the effectiveness of various treatments for any given condition.
6. The aim of Science, Technology, Engineering and Mathematics (STEM) Education research is to develop and identify the most effective methods for teaching these subjects.  Innovative and effective methods of teaching STEM subjects are essential to sustain the biomedical research and health care delivery enterprises.  We must continue to inspire new generations to pursue careers in science and medicine, as well as foster a community that has sufficient science and health literacy to create policies that foster the biomedical research and the health care sectors.

Finally, research in the areas of health disparities and bioethics will work to increase the integrity of the health care system for all users.

1. Health Disparities as defined by the Health Resources and Services Administration (HRSA) refers to the “population-specific differences in the presence of disease, health outcomes, or access to health care.”  The aim of research in the area of health disparities among ethnic
   

   The Basics of Stem Cell Research (from NIH)

   minorities and medically under served populations is to elucidate and then alleviate the causes of increased burned of disease and poorer health outcomes for specific disease conditions, as well as bring greater parity for access to care among all populations.  This research ensures that the gains made in the aforementioned research disciplines such as biomarker discovery, genomics, theranostics and regenerative medicine truly benefit the entire population.

2. The aim of Bioethics research is to protect patients’ rights throughout the biomedical research and health care delivery enterprises. The verve of technology must always be tempered by sound ethics to guard against the unforeseen consequences of the new (as are many of the research areas previously described).  Framed around four principles that promote patient well-being (beneficence), protect them from harm (non-maleficence), respect their right to accept or deny treatment (autonomy) and generally promote the pursuit of what is right (justice), bioethics provides safeguards in medical research and medical practice.

These are the fifteen research areas upon which the nation’s premier clinicians and biomedical research scientists will focus their investigations.  As a result, passage of the Recovery Act has not only managed to rehabilitate the proximate future but most certainly transform our distant future, as well.  I believe there will be gains in health and medicine that heretofore could have only been imagined.  What do you think?  Are there research focus areas that excite you? Perhaps, you know someone suffering from a disease that will benefit from these areas of research.  Or are you a pessimist awaiting the apocalyptic signs of a Brave New World, concerned that we made the wrong decision by restoring funding to embryonic stem cell research?  Either way, leave me a comment voicing your hopes or concerns.

Sources:

What is Regenerative Medicine. In McGowan Institute for Regenerative Medicine. Cited April 10, 2009.  Available at <http://www.upmc.com/Services/MIRM/RegenerativeMedicine/Pages/default.aspx>

Anerson, D.G. Burdick, J.A. and Langer, R.  (2004).  Materials Science. Smart Biomaterials. Science. September 24;305(5692):1923-4.

Re-engineering the Clinical Research Enterprise: Translational Research.  In NIH Roadmap for Medical Research.  Cited April 10, 2009.  Available at <http://nihroadmap.nih.gov/clinicalresearch/overview-translational.asp>

Skeen, J. (Ed.). (2007, December). Research on the Comparative Effectiveness of Medical Treatments:  Isuues and Options for an Expanded Federal Role [Electronic Version]. Available from the Congressional Budget Office, Ford House Office Building, 4th Floor Second and D Streets, SW Washington, DC 20515.

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ARRA and You (Part IVa): Challenge Grant Research Priorities. The impact of the American Recovery and Reinvestment Act of 2009 on the health sector is so broad ultimately, it will touch all our lives. From COBRA insurance premium assistance and funding to the states for Medicaid and SCHIP to improved funding for research in the health and biomedical sectors, there appears to be no area left unaffected by the comprehensive legislation. As part of the Recovery Act, NIH has designated no less than $200 million, in the upcoming fiscal year, to fund research in areas that “address specific scientific and health research challenges in biomedical and behavioral research.” Science administrators hope to take advantage of opportunities to fill gaps in knowledge, develop new technologies, refine research methods and generate data. These areas of priority to which challenge grant funds will be awarded will influence this sector for years to come in the following three ways.

1. Application of cutting-edge 21st century technologies will transform the way we diagnose and treat disease to a more personal and molecular level.
2. Information technology and older research methodologies will combine to increase health care system efficiency.
3. Research in the areas of bioethics and health disparities will work to increase the integrity of the health care system.

In what ways do you think ARRA funding will impact biomedical research and the health care system on the whole?  Keep an eye out for the next post, in which I’ll discuss each priority research area further.

Source:

NIH Challenge Grants in Health and Science Research. In Office of Extramural Research. Cited on April 6, 2009.  Available at <http://grants.nih.gov/grants/funding/challenge_award/>

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