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Laurie Quade plays with her adopted son, Simon. She has premature ovarian failure or POF, a condition that affects one percent of all women of childbearing years, and participates in a three-year research study trying to find the best treatment for it. Quade, her husband Mark Bagne and Simon reside in Cody, Wyoming.
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Resources for Intramural Researchers
Standards for Clinical Research
The Standards for Clinical Research, established in 2000, set forth essential principles and processes for the conduct of clinical research in the NIH intramural research program. These standards relate to patient safety, protocol implementation, quality assurance, training of clinical investigators and infrastructure to support research initiatives. In 2003, compliance with the Standards for Clinical Research was assessed for each institute’s or center’s intramural program through a peer review process developed by the Clinical Center’s Medical Executive Committee (MEC).
Bench-to-Bedside Awards
Bench-to-Bedside Program awards are designed to foster new collaborations between basic and clinical investigators across the NIH institutes and centers. In this program intramural researchers translate scientific findings into clinical applications. Often the areas of research being studied have the potential for improving the understanding of an important disease process or for leading to a new therapeutic intervention. Since its inception in 1998 more than 225 proposals have been submitted and 45 projects have been funded. The awards were supported by Clinical Center carry-over funds for the first two competitive cycles, after which the institutes agreed to continue the program with their own funds. In 2003, in addition to institute funds, new sources of funding were identified through the NIH Office of Rare Diseases and the NIH Office of AIDS Research.
Protocol Services
The purpose of this specialized unit is to better facilitate clinical research during the protocol phases of development, approval, implementation, and evaluation/monitoring and to provide principal investigators with tools and applications that help simplify the entire protocol process. Formerly known as the Protocol Coordination Center, the Office of Protocol Services was established in 2002.
Information Systems
Clinical Research Information System (CRIS)
CRIS is a far-reaching, $60 million project that will provide a broad information-technology foundation to support the future of clinical research at NIH. It will offer innovations in managing, analyzing and using valuable information surrounding clinical research. Work in 2003 focused on designing and building a state-of-the-art replacement for the Clinical Center’s existing medical information system originally developed in 1975. Implementation of CRIS is planned for mid-2004 in preparation for the opening of the new Mark O. Hatfield Clinical Research Center.
ProtoType—Assisted Protocol Writing
ProtoType is an effort to simplify the bureaucracy for clinical research investigators. This information system initiative was developed in the past year and a half to facilitate protocol development and implementation. ProtoType provides a web-based standardized protocol template. When using this online interactive tool investigators are guided through the process of protocol development and given links to important NIH, Clinical Center and government-wide policies and requirements. The first phase of ProtoType was completed in 2003.
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Clinical Research Accomplishments
In 2003 Clinical Center departments supported new and expanding areas of science including molecular imaging techniques, pharmacology, immune cell harvesting, and advances in biomechanics. Along with facilitating the biomedical research efforts of colleagues in institute or center intramural programs, Clinical Center researchers continue to be recognized for their scientific accomplishments.
A sampling of scientific endeavors currently pursued by Clinical Center researchers in the areas of clinical bioethics, imaging sciences, transfusion medicine, critical care medicine, and pharmacology follows. More details may be found in the Annual Report of Clinical Research Activities (http://clinicalcenter.nih.gov/about/_pdf/arcurrent.pdf) which summarizes clinical research projects directed by Clinical Center investigators.
Clinical Bioethics
The Department of Clinical Bioethics is investigating non-physician practitioners (nurse practitioners and physician assistants) and their perceptions of ethical issues associated with primary care practice. In international research ethics NIH bioethicists are studying the perceptions of benefits and risks of biomedical research in a developing country and are also working to evaluate the quality of informed consent for enrollees in a male circumcision for HIV prevention trial.
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Enjoying a bit of relaxation and sport, Bob Grill (left) of Davidsonville, Maryland plays pool with Brad Emmett of Secor, Illinois. The two men became “buddies” when they met as heart patients in a stem cell study. Researchers from the National Heart, Lung and Blood Institute are working to see if stem cells pushed out into the bloodstream will relocate, growing new heart muscle and blood vessels damaged by coronary artery disease.
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Imaging Sciences
Progress continues on an intraoperative imaging project, a collaborative effort between the Imaging Sciences Program in conjunction with the National Cancer Institute and the National Institute of Neurological Disorders and Strokes, which will provide a real-time magnetic resonance imaging capability in the surgical suite. A new molecular imaging laboratory is now fully functional and provides researchers in the Imaging Sciences Program the capacity to team with scientists from varied disciplines as they explore new ways of imaging molecular events in vivo and develop new targeted imaging and therapeutic agents.
Transfusion Medicine
In the Department of Transfusion Medicine studies are ongoing to improve the method of collecting adult stem cells to reconstitute the bone marrow and immune system of patients who undergo transplants for leukemia and solid tumors. Researchers are also evaluating blood donors and recipients to determine the frequency and importance of transfusion-transmitted infections and a genetic analysis study is underway to determine if there is a benefit to post-transfusion platelet survival when the resolution of donor/recipient matching is increased.
Critical Care Medicine
Researchers in the Critical Care Medicine Department are studying nitrite, a common small ion, or salt, in blood that can improve blood flow by opening blood vessels and increasing oxygen in the blood as a potentially new treatment for diseases such as high blood pressure and heart attacks. The use of nitric oxide inhalation therapy is being studied for its use in the treatment of sickle cell anemia and pain. Critical Care Medicine physicians are also investigating the role genomics and proteomics may play in aiding patients with life-threatening diseases that often develop clinical complications and organ dysfunction due to the effects of unregulated inflammation.
Pharmacy
The Pharmacy Department is researching dosage-form design and pharmacokinetics, the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. A specialized research unit, the Clinical Pharmacokinetics Research Laboratory, conducts pharmacokinetic and pharmacogenetic research that helps optimize drug therapy. Kineticists are investigating possible explanations for differences in drug absorption, distribution and metabolism. They are also studying genetic predisposition to drug toxicity or serious drug interactions with certain medications.
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