The NIH Almanac
NIH Clinical Center
The NIH Clinical Center is the nation's largest hospital devoted entirely to clinical research. Clinician-investigators translate scientific observations and laboratory discoveries into new approaches to diagnosing, treating, and preventing disease. The Clinical Center was recognized with the 2011 Lasker~Bloomberg Public Service Award for serving as a model research hospital—providing innovative therapy and high-quality patient care, treating rare and severe diseases, and producing outstanding clinician-scientists whose collective work has set a standard of excellence in biomedical research.
About 1,500 clinical research studies are in progress at the Clinical Center. Half are studies of the natural pathogenesis of disease, especially rare diseases, which often are not studied anywhere else. What researchers learn by studying rare diseases adds to the basic understanding of common diseases. Most other studies are clinical trials, the first tests of new drugs and therapies in people. The clinical trials at the Clinical Center are predominantly Phase I and Phase IIófirst-in-human to test safety and efficacy. Clinical and laboratory research is conducted shoulder-to-shoulder, and this tandem approach drives all aspects of the Clinical Centerís operations.
More than 400,000 research volunteers have participated in clinical research studies at the Clinical Center since the hospital opened in 1953. Each year, the center sees 10,000 new research participants, of which there are two types: patient volunteers and healthy volunteers. Patient volunteers are people with specific diseases or conditions who help medical investigators learn more about their condition or test new medications, procedures, or treatments. A healthy volunteer is a person with no known significant health problems who plays a vital role in research to test a new drug, device, or intervention.
At the Clinical Center, clinical research participants are active partners in medical discovery, a partnership that has resulted in a long list of medical milestones, including the first cure of a solid tumor with chemotherapy, gene therapy, use of AZT to treat AIDS, and successful replacement of a mitral valve.
Important Events in CLINICAL CENTER History
November 1948—Construction of the Clinical Center is started.
June 22, 1951— President Harry S. Truman is the honored guest for the cornerstone ceremony.
July 2, 1953—The Clinical Center is dedicated by DHEW Secretary Oveta Culp Hobby.
July 6, 1953—The first patient is admitted to the Clinical Center.
1954—The Clinical Center's diagnostic X-ray department acquires the only Schnonander angiocardiographic unit in the United States. It takes films in two planes at the rate of six films per second, permitting a graphic demonstration of contrast substances as they pass through the heart, making diagnosis faster and more accurate.
1957—The Clinical Pathology Department develops the first automated machine for counting red and white blood cells (until then counted manually).
1957—The Blood Bank publishes its first research paper, delineating the post-transfusion hepatitis problem, firing the first salvo in a long but largely successful campaign.
1959—A new, circular surgical wing is built.
September 5, 1963—A new surgical wing for cardiac and neurosurgery was dedicated by Luther L. Terry, Surgeon General.
1963—The Blood Bank moves to a new area and blood collections begin on the NIH campus.
1964—Harvey Alter (Clinical Center) and Baruch Blumberg (NIDDK) co-discover the Australian antigen, which Blumberg later shows to be the surface coating of the hepatitis B virus, leading to the isolation of this medically important virus. Blumberg later wins the Nobel Prize. Alter, who later receives the Lasker Award, does pioneering work in the causes and prevention of blood-transmitted infections, which helps lead to the discovery of the virus that causes hepatitis C and the development of screening methods that will reduce the risk of transfusion-transmitted hepatitis.
1964—John L. Doppman and associates in diagnostic radiology report the first successful imaging of the arteries that supply the spinal cord. The technique of spinal angiography makes surgical intervention possible where spinal arterial malformations, lesions, or tumors cause paralysis.
1966—A Nuclear Medicine Department is established in the Clinical Center.
1966—Wanda S. Chappell, chief nurse in the Blood Bank, comes up with a simple but ingenious method for separating blood platelets (the smallest blood cells) from blood plasma, so that the platelets can be used for transfusion to leukemia patients and the rest of the blood can be used by others, including patients undergoing open heart surgery.
1968—Diagnostic radiologist John L. Doppman develops a method for locating the parathyroid, a group of glands (each about the size of a BB pellet) that regulates calcium metabolism.
1970—The Blood Bank switches to an all-volunteer donor system, and adds a test for hepatitis B surface antigen. Those two measures alone reduce the hepatitis rate from 30 percent before 1970 to about 11 percent after. Later, when it adds more sensitive tests for hepatitis B, the virus virtually disappears as a problem in the Blood Bank.
1972—Blood Bank scientists develop a test for the antigen associated with hepatitis. The test will be used nationally.
1976—The electronic medical information system—one of the nation's first—is introduced.
April 1977—Construction of the ambulatory care research facility is started.
November 1977—The Critical Care Medicine Department is established.
1977—The Blood Bank establishes therapeutic apheresis/exchange programs that for decades will improve the lifespan and welfare of patients with such illnesses as sickle cell disease, hyperlipidemia, and autoimmune disorders. It also establishes the first automated platelet-pheresis center, collecting platelets for transfusion from volunteer donors using automated instrumentation.
1980—The research hospital is renamed the Warren Grant Magnuson Clinical Center, in honor of the former chairman of the Senate Committee on Appropriations, who has actively supported biomedical research at NIH since 1937. (P.L. 96-518.)
June 16, 1981—The first patient with the new disease, later to be named AIDS/HIV, is seen at the Clinical Center.
1981—Clinical research dietitians develop standards of care for the clinical nutrition service and devise diets with controlled intake of certain nutrients to support clinical research.
1982—A new surgical facility and a surgical intensive care unit opens.
March 22, 1984—The first magnetic resonance imaging unit becomes operational for patient imaging.
1984—The Clinical Center Blood Bank is renamed the Department of Transfusion Medicine (DTM) because its activities extend well beyond traditional blood banking. DTM achieves the first transmission of HIV (HTLV III) to a primate through transfusion and describes the HIV seronegative window.
April 13, 1985—Two cyclotrons are delivered to the underground facility operated by the Nuclear Medicine Department.
1986—The Clinical Center signs an agreement to become one of the first donor centers participating in the National Marrow Donor Program.
September 14, 1990—A 4-year-old patient with adenosine deaminate deficiency is the first to receive gene therapy treatment.
April 8, 1991—DTM opens its state-of-the-art facility.
July 1993—The hematology/bone marrow unit opens to improve transplant procedures and develop gene therapy techniques.
May 1994—A multi-institute unit designed and staffed for children opens.
1995—The course “Introduction to the Principles and Practice of Clinical Research” is first offered. It provides education in the basics of safe, ethical, and efficient clinical research.
February 1996—Details on clinical research studies conducted at the Clinical Center are made available online (http://clinicalstudies.info.nih.gov/), increasing opportunities for physicians and patient volunteers to participate in NIH clinical investigations.
November 1996—A Board of Governors is appointed by the Secretary of HHS, marking a new governing system for the Clinical Center.
July 1997—DTM launches a 3,000-square feet model core [cGMP] cell processing facility, created to meet increasing investigative needs for cell products used in new cellular therapies such as immunotherapy, gene therapy, stem cell transplantation, and pancreatic islet cell transplantation.
November 4, 1997—Vice President Al Gore and Senator Mark O. Hatfield attend groundbreaking ceremonies for the Mark O. Hatfield Clinical Research Center, designed to include a new hospital and research laboratories.
1999—The Clinical Pathology Department is renamed the Department of Laboratory Medicine.
1999—The Bench-to-Bedside Awards program is established to speed translation of promising laboratory discoveries into new medical treatments by encouraging collaborations among basic scientists and clinical investigators.
2000—The NIDDK and the Clinical Center (in collaboration with Walter Reed Army Medical Center, the Naval Medical Research Center, and the Diabetes Research Institute of the University of Miami) launch a new kidney, pancreas, and islet transplant program. The idea is to test novel therapies that may eliminate the need for the immunosuppressive drugs patients take to keep their bodies from rejecting new transplanted organs.
2000—The Clinical Center launches a new Pain and Palliative Care Consult Service.
2000—The Imaging Sciences Program takes first steps toward filmless radiology, unveiling the pilot phase of its new Picture Archiving and Communication System (PACS) and Radiology Information System (RIS).
2001—A second bone marrow transplant unit opens to support NCI protocols.
2002—DTM establishes a model program for collecting blood from subjects with hereditary hemochromatosis. This program supplies 10 percent of the hospital's red cell needs.
October 29, 2002—A groundbreaking ceremony is held for the Edmond J. Safra Family Lodge. Located steps away from the Clinical Center, the lodge provides a comfortable home away from home for the families and caretakers of Clinical Center patients.
2003—The Office of Clinical Research Training and Medical Education is established to help train the next generation of clinical researchers.
2004—As recommended by the NIH Director's Blue Ribbon Panel on the Future of Intramural Clinical Research, the former Clinical Center Board of Governors assumes a new and larger identity, becoming the NIH Advisory Board for Clinical Research. The board oversees all intramural clinical research, while continuing its oversight of Clinical Center resources, planning and operations.
2004—The Clinical Center formalizes an emergency preparedness partnership with Suburban Hospital and the National Naval Medical Center.
August 21, 2004—The electronic Clinical Research Information System goes live.
September 22, 2004—The dedication ceremony is held for the Mark O. Hatfield Clinical Research Center.
2005—Radiologist Ronald M. Summers finds that computer-aided software, in conjunction with a procedure commonly called virtual colonoscopy, can deliver results comparable to conventional colonoscopy for detecting the most worrisome types of polyps.
2005—Bioethics chief Ezekiel Emanuel co-authors a study suggesting that minority involvement in clinical research is more a matter of access than attitude.
2005—The Rehabilitation Medicine Department opens its clinical movement analysis lab, a joint venture with the NICHD.
April 2, 2005—Patients are moved into the Mark O. Hatfield Clinical Research Center and the building becomes fully operational.
May 26, 2005—An opening ceremony is held for the Edmond J. Safra Family Lodge. The lodge opens its doors to guests on June 1.
2006—The Bench-to-Bedside Awards program extends to include intramural and extramural collaborations.
2006—Nursing and Patient Care Services initiates a collaboration with the Indian Health Service to increase clinical nursing research capabilities.
2007—The first of 1,000 volunteers are enrolled in a study led by the NHGRI to test the use of human genome sequencing in a clinical research study.
January 25, 2007—A ribbon-cutting ceremony is held for a new NIH metabolic clinical research unit that provides researchers from multiple institutes the opportunity to study obesity and related conditions, such as diabetes, heart disease and certain cancers.
2008—The Undiagnosed Diseases Program is established, led by the NHGRI, the NIH Office of Rare Diseases, and the Clinical Center to help and learn from patients who have eluded diagnosis.
2008—Clinical Center nurses undertake a multi-year project to define the clinical research domain of practice and lead the way in establishing it as a recognized nursing specialty practice.
2008—An adaptation of the Clinical Center course “Introduction to the Principles and Practice of Clinical Research” is presented in Beijing.
2008—The Clinical Center begins a partnership with the Uniformed Services University of the Health Sciences and the Department of Defense to conduct clinical research studies in the fields of neuroscience and regenerative medicine. The research involves military and civilian populations.
2009—Two new trans-NIH imaging resources are initiated, the Center for Interventional Oncology and the Center for Infectious Diseases Imaging.
2009—In July, the Biomedical Translational Research Information System (BTRIS), launches its NIH-wide intramural research data repository allowing investigators to view identified data from their active protocols. In December, intramural researchers are able to access de-identified data from clinical and research systems across the NIH intramural programs. BTRIS is designed to facilitate hypothesis generation, data gathering, and analysis.
2009—DTM begins use of a prototype cell expansion system to automate bone marrow stromal cell expansion.
2009—CT and PET/CT equipment purchased by the Clinical Center is now required to routinely record radiation dose exposure in a patient's hospital-based electronic medical record.
January 2010—The Pharmacy Department opens a state-of-the-art pharmaceutical development facility where staff formulate and analyze vaccines and medications not available from manufacturers. These products account for one-third of the drugs (including placebos and varying strengths) that the Clinical Center uses in its research protocols.
April 2010—The NIAID seven-bed Special Clinical Studies Unit opens, with advanced isolation and extended-stay capabilities.
June 2011—The Clinical Center graduates 12 interns from the pilot NIH-Project SEARCH internship program, providing employment opportunities and experience for young adults with developmental disabilities.
September 2011—The Clinical Center is named the 2011 recipient of the Lasker~Bloomberg Public Service Award from the Albert and Mary Lasker Foundation. The award honors the Clinical Center for serving as a model institution that has transformed scientific advances into innovative therapies and provided high-quality care to patients.
October 2011—The Clinical Center acquires one of the first fully integrated whole-body simultaneous PET and MRI devices.
February 2012—The Clinical Center established a Memorandum of Understanding allowing NIH intramural clinical studies of children under the age of two in the Clinical and Translational Science Award (CTSA) clinical unit at Children's National Medical Center in Washington, DC.
March 2012—A new Joint Taskforce between the Clinical Center & the Food and Drug Administration was created to consider exceptions to existing Investigational New Drug policies and procedures for extraordinary clinical circumstances.
August 2012—Researchers from the Clinical Center and National Human Genome Research Institute published a novel use of genome sequencing to help quell Klebsiella pneumonia bacteria outbreak at the Clinical Center in Science and Translational Medicine.
August 2012—The Clinical Center announces a new grant program, Opportunities for Collaborative Research at the NIH Clinical Center, which will support partnerships to expand engagement with extramural investigators interested in collaborating with intramural researchers, using the Clinical Centerís unique resources.
September 2012—The first class of the new NIH Medical Research Scholars Program started the year-long research enrichment program, engaging in a mentored basic, clinical, or translational research project that matches their professional interests and career goals.
CC Legislative Chronology
July 1, 1944—Public Law 78-410, the Public Health Service Act, authorized establishment of the Clinical Center.
July 8, 1947—Under P.L. 80-165, research construction provisions of the Appropriations Act for FY 1948 provided funds "For the acquisition of a site, and the preparation of plans, specifications, and drawings, for additional research buildings and a 600-bed clinical research hospital and necessary accessory buildings related thereto to be used in general medical research."
BIOGRAPHICAL SKETCH OF CC DIRECTOR JOHN I. GALLIN, M.D.
Dr. John Gallin was appointed director of the Clinical Center in 1994. The Clinical Center serves the clinical research needs of 17 NIH institutes and is the largest hospital in the world totally dedicated to clinical research. During his tenure, Dr. Gallin has overseen the design and construction of a new research hospital for the Clinical Center, the Mark O. Hatfield Clinical Research Center, which opened to patients in 2005; the establishment of a new curriculum for clinical research training now offered globally; and development of new information systems for biomedical, translational, and clinical research. In 2011, under Dr. Gallinís leadership, the Clinical Center received the Lasker~Bloomberg Public Service Award.
While serving as Clinical Center director, Dr. Gallin has continued to be an active clinical investigator. His primary research interest is in a rare hereditary immune disorder, chronic granulomatous disease (CGD). His laboratory described the genetic basis for several forms of CGD and has done pioneering research that has reduced life-threatening bacterial and fungal infections in CGD patients.
A New York native, Dr. Gallin attended public school in New Rochelle, New York; graduated cum laude from Amherst College from which he later received an honorary doctorate. He earned an M.D. degree at Cornell University Medical College. After a medical internship and residency at New York Universityís Bellevue Hospital, he received postdoctoral training in basic and clinical research in infectious diseases at NIH from 1971 to 1974. He then went back to New York University's Bellevue Hospital as senior chief medical resident from 1974-1975 before returning to NIH.
In 1985, Dr. Gallin began a nine-year period as scientific director for intramural research activities at the National Institute of Allergy and Infectious Diseases. Dr. Gallin was the founding chief of the NIAID Laboratory of Host Defenses, served as chief of the laboratory for 12 years, and continues as chief of the lab's clinical pathophysiology section.
He has published more than 325 articles in scientific journals and has edited two textbooks—"Inflammation, Basic Principles and Clinical Correlates" (Lippincott, Williams, and Wilkins, 1999, now in 3rd edition) and "Principles and Practices of Clinical Research" (Academic Press, 2002, now in 3rd edition).
Dr. Gallin is a member of the American Society for Clinical Investigation, the Association of American Physicians, the Institute of Medicine of the National Academy of Sciences, and he is a Master of the American College of Physicians.
Clinical Center Directors
|Name||In Office from||To|
|John A. Trautman||1951||1954|
|Donald W. Patrick||1954||1956|
|Thomas C. Chalmers||1970||1973|
|Robert S. Gordon, Jr.||1974||1975|
|Mortimer B. Lipsett||1976||1982|
|John L. Decker||1983||1990|
|Saul Rosen (Acting)||1990||1994|
|John I. Gallin||May 1, 1994||present|
As America's research hospital, the Clinical Center leads the global effort in training today's investigators and discovering tomorrow's cures.
The Clinical Center's mission is to provide a versatile clinical research environment enabling the NIH mission to improve human health by:
- Investigating the pathogenesis of disease
- Conducting first-in-human clinical trials with an emphasis on rare diseases and diseases of high public health impact
- Developing state-of-the-art diagnostic, preventive, and therapeutic interventions
- Training the current and next generation of clinical researchers
- Ensuring that clinical research is ethical, efficient, and of high scientific quality
Major components: Administrative Management; Bioethics; Clinical Epidemiology and Biostatistics; Clinical Research Informatics; Clinical Research Training and Medical Education; Communications and Media Relations; Credentials Services; Critical Care Medicine; Edmond J. Safra Family Lodge; Financial Resource Management; Hospital Epidemiology; Housekeeping and Fabric Care; Hospitality Services; Internal Medicine Consults; Laboratory Medicine; Laboratory for Informatics Development; Management Analysis and Reporting; Materials Management; Medical Records; Nursing; Nutrition; Pain and Palliative Care; Patient Recruitment; Perioperative Medicine; Pharmacy; Purchasing and Contracts; Rehabilitation Medicine; Transfusion Medicine; Pediatric Consults; Protocol Services; Radiology and Imaging Sciences; Social Work; Space and Facility Management; Spiritual Care Ministry; Veterinary Care; Workforce and Management Development.