Standards in Clinical Research. These standards cover the essential principles and processes for the conduct of clinical research at NIH. They were developed by the Medical Executive Committee and endorsed by the Board of Governors, the Clinical Center Advisory Council, and the institute directors and scientific directors. Implementation of the infrastructure includes enhancements in clinical informatics, data management, and protocol tracking; biostatistics support; quality assurance and quality control; protocol review; 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 incorporate the standards into everyday practice.

Stem Cell Harvesting. Both the National Cancer Institute and the National Heart, Lung and Blood Institute have increased their emphasis on bone marrow transplantation. To meet these clinical and research needs, the CC Department of Transfusion Medicine has dramatically expanded its capacity to perform stem cell harvests. In addition, DTM has increased support for tumor vaccine protocols over the past year. The expanded stem cell harvesting facility also prepares cells for gene therapy and pancreatic islet cells in support of the new solid organ transplant program.

Solid Organ Transplant Program. The National Institute of Diabetes, Digestive and Kidney Diseases initiated a new solid organ transplantation program in response to identified scientific opportunities. The CC provided staff and oversight for the cross-disciplinary team that created the new program. The CC obtained United Network for Organ Sharing certification as a transplant center, identified additional resources needed to support the program outlined by NIDDK, developed a proposal for staffing and equipping the program, recruited and trained new staff for the operative and clinical care teams, and supervised the renovation of the 11 East patient care unit and opening of the transplant unit. The program implemented four protocols and accrued 271 patients in 2000.

Bench-to-Bedside Program. In l998, the Clinical Center made funding available to NIH intramural researchers for translating scientific findings into clinical applications. More than 40 proposals were submitted the first year, and 1-year funding was provided for eight projects. In 1999, from a pool of approximately 80 submissions, six projects were recommended for 2-year funding (an additional three projects received 1-year funding). In 2000, a progress report revealed that many of these bench-to-bedside initiatives resulted in clinical protocols, and most resulted in scientific publications. Since 1998, these projects have been funded by Clinical Center carryover funds. This year, institute and scientific directors endorsed using institute resources for this program.

Intraoperative Imaging. This initiative will provide real-time magnetic resonance imaging capability in the surgical suite. Through the trans-institute planning process, two institutes indicated a clear need for augmented imaging capability in the operative setting. Project scope and equipment specifications were determined in 2000. Equipment installation is expected to be completed in 2001.

Biostatistics Support. The Clinical Center has initiated a Clinical Epidemiology and Biostatistics Service for its investigators and, as needed, for supporting protocols of the NIH scientific community. In operation since August, the program assists investigators in protocol design, execution, and analysis. As protocols move forward, the biostatisticians are available to consult on data collection and analysis. Staffing the new service are Robert Wesley, Ph.D., and Deloris Koziol, Ph.D., M.P.H, a clinical epidemiologist.

Protocol Services. The CC expanded its protocol development services to the institutes. These services include administrative and regulatory-compliance support, coordination with outside review bodies and internal services; and protocol review and development.

Clinical Research Information System (CRIS). This year the CC began working on plans for a new clinical research information system that will provide a single, continuous record of care delivered at the Clinical Center. It will provide access to patient data for referring physicians, incorporate real-time alerts and reference material, provide comprehensive security to protect patient privacy, and provide protocol-based ordering. In January 2000, the CC contracted the Orkand Corporation to help develop materials to procure the new system. The contract is expected to be awarded in late 2001.

Picture Archiving and Communication System/Radiology Information System. A multiyear, multimillion-dollar effort to initiate filmless radiology services and automated radiology patient tracking was initiated this year. This system will automate acquiring, transmitting, storing, and displaying digital diagnostic images and written reports. PACS/RIS will integrate new and existing x-rays and scans with medical record information and patient demographics. The first phase, RIS, which provides automated patient tracking and radiology reports, began operating in September. When it is completed in 2001, the system will display radiology images on workstations and desktop computers across NIH. It will eventually be integrated into the CRIS system.

Veterinarian Support. The CC recruited and hired Dr. Mark C. Haines as new animal program director. This position was changed from a part-time to a full-time position. The new CC veterinarian and animal program director will help CC investigators achieve a new level of quality in their ongoing animal studies.

Clinical Trial Phase descriptions: Phase I: Researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Phase II: The study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. Phase III: The study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will ensure safe usage. Phase IV: These studies are done after the drug or treatment has been marketed. The testing continues to collect information about the effect of the drug or treatment in various populations and determine any side effects from long-term use.

Contents

Introduction

Clinical Research Center

From the Director

Major Programs

History

Governance

Research Initiatives

Research Spotlight

Training Programs

Patient Care and Support

Organizational Initiatives

Outreach