Standards in Clinical Research. Training and the infrastructure to support clinical research have remained high priorities. A long-standing Clinical Center goal has been the establishment of standards for clinical research for NIH’s intramural program that serve as a model for research institutions across the country. Working with its Medical Executive Committee the Center created a framework of standards that provide the necessary training and infrastructure to support clinical investigators and to maximize patient safety. These Standards for Clinical Research within the NIH Intramural Program were endorsed by the Center’s Board of Governors, approved by its Scientific and Clinical Directors, and adopted by NIH Institute Directors in 2001. Implementation of the standards is under way and includes enhancements in clinical informatics, data management, protocol tracking, protocol review, biostatistics support, quality assurance and quality control, identification of human resources needs and physical plant upgrades, and training and education for clinical investigators. Every investigator involved in clinical research at NIH is required to utilize the standards as common practice.

Bench-to-Bedside Program. Designed to initiate new collaborations between basic and clinical investigators across NIH Institutes, enthusiasm for the bench-to-bedside program continues to be evident among intramural investigators. In the bench-to-bedside program intramural researchers translate scientific findings into clinical applications. Since its inception in 1998, 32 bench-to-bedside awards have been initiated. Through this program intramural scientists from multiple Institutes and across disciplines join forces to work on projects designed to move research studies into the clinical setting.

	Diagnostic radiology that utilizes digital diagnostic images and written reports is one of several services provided by the Imaging Sciences Program.

Imaging Sciences
Intraoperative Imaging. This initiative will provide a real-time magnetic resonance imaging capability in the surgical suite. Under the direction of King Li, M.D., M.B.A., Associate Director for Imaging Sciences, the project continues to move toward implementation. Construction plans are now complete. This is a collaborative effort between the Clinical Center, the National Cancer Institute and the National Institute of Neurological Disorders and Stroke. Interested clinicians are participating in the development of research plans for the utilization of this technology.

Picture Archiving and Communication System/Radiology Information System (PAC/RIS). A multi-year, multi-million dollar effort to initiate filmless radiology services and automated radiology operations began operation in 2000. This system currently acquires, stores, retrieves, distributes and displays digital diagnostic images and written reports within the Imaging Sciences Program. An enterprise-wide version is currently being tested and will be introduced NIH-wide during the summer of 2002. When it is completed, the system will display radiology images and reports on workstations and desktop computers across NIH. It will eventually be integrated into the Clinical Research Information System.

Molecular Imaging. Current medical imaging relies mostly on anatomic infor-mation. In the post-genomic era, the goal of biomedical imaging is to provide information about biologic events at the molecular level noninvasively in three dimensions and in a temporally resolved manner. This will allow the interactive study of complex biologic processes. In order to achieve this, a molecular imaging program at the Clinical Center will combine advances in physics, engineering, molecular biology, chemistry, genomics, proteomics, and image analysis. This translational research program will provide new tools for clinical research allowing the Center to stay at the cutting edge of imaging sciences.

Clinical Research Information System (CRIS). CRIS represents the Clinical Center’s next-generation clinical information infrastructure. The NIH-wide enterprise system will provide the electronic backbone to support research data collection, patient care documentation and resource consumption. This past year the CRIS management team established a governance and project management structure, held educational sessions to present the system and topics related to clinical informatics, developed its budget and business case, launched a procurement process, and completed market survey visits to other healthcare institutions. Evaluation of protocol mapping software was completed and a functional and technical review of CRIS requirements was also conducted. The current project focus involves product acquisition and radiology picture archival deployment.

Secure e-mail. The safe, protected transmission of clinical data via electronic mail is facilitated through the use of secure e-mail. As a result of a recommendation of the Clinical Center’s Medical Executive Committee secure e-mail became available to both NIH Institute and Clinical Center clinical teams this past year for use throughout the Clinical Center. Encrypted e-mail assures patient information confidentiality. Once a message is encrypted, it is virtually impossible to “hack.” It is anticipated that by the end of 2002 each NIH Institute or Center will utilize encryption for e-mail transmission when communicating confidential information within the organization. A common security standard is expected to be devised that will allow the transmission of secure messages between NIH and non-NIH organizations is expected to be devised over the next year.

Transfusion Medicine
Transfusion-transmitted Infections. The Department of Transfusion Medicine has begun a study of blood donors and recipients to determine the frequency and importance of transfusion-transmitted infections. Specimens from donated blood will be tested for a variety of infectious agents and stored long-term for detection of infectious agents that may emerge in the future. Transfusion recipients will be followed for years to determine whether they have developed infections from transfusions and what impact this might on have their future health. Previous studies conducted by the department of Transfusion Medicine have defined the clinical importance of post-transfusion Hepatitis B and C and HIV.

Islet Cell Program. A laboratory service has been established to isolate pancreatic islets from cadaver organ donors. The process isolates islets, which contain beta cells that produce insulin, and transplants those islets into the livers of patients with Type 1 diabetes. The islet transplant is done through an injection using interventional radiology. The outcome may free Type 1 diabetes patients from being insulin dependent or decrease the amount of insulin they require. This program is led by the National Institute of Diabetes and Digestive and Kidney Diseases and is supported by the Clinical Center.

Platelet Transfusion. More than 30,000 units of platelets for transfusion are collected annually by the Department of Transfusion Medicine in about 4,500 procedures. About 10 percent of these transfusions have limited clinical success meaning minimal or no increase in platelet count. A mole-cular complex on the surface of most cells, Human Leukocyte Antigen (HLA) is responsible for rejection of transplants. A genetic analysis study is being done to determine if there is a benefit to platelet survival by increasing the resolution of donor/recipient matching. If this is found to be true then donors can be selected not only for platelet transfusions but also for other forms of transfusion and transplantation where histocompatibility could be increased through better matching.

Immune Cell Harvesting. The use of donor natural killer (NK) cells in the setting of genetically different blood cell transplantation is being investigated. There is evidence that NK cells might have anti-leukemia or anti-tumor properties and do not appear to cause graft-versus-host disease. This means there may be a role for giving NK cells to patients as part of the transplant regimen. Work is being conducted to develop methods for isolating, manipulating, storing, and assaying the NK cells. This project is being done in collaboration with the National Heart, Lung, and Blood Institute.

Contents

Introduction

Message from the Director

Historical Highlights

Clinical Center Governance and Accreditation

Major Programs

The Mark O. Hatfield Clinical Research Center

The Edmond J. Safra Family Lodge

Clinical Research Initiatives

Clinician Highlight

Clinical Research Training Programs

Organizational Effectiveness and Efficiency Initiatives

Public Outreach