Clinical research is at the heart of the Clinical Center's mission.
Supporting Clinical Research
About a thousand clinical research studies are under way at the Clinical Center, most of them sponsored by the Institutes and Centers at NIH. These different institutes, centers, and divisions study diseases such as cancer, AIDS, heart trouble, eye problems, dental problems, depression, and nerve diseases, to name just a few.
Natural history studies, often in patients with rare diseases, make up about half of the studies. Understanding the basis for rare diseases often leads to new approaches to common problems. Most of the other clinical research studies are the early (Phase 1 and 2) trials that are the first applications of basic, bench-side research into new treatments and therapies in people. Please visit our database of studies for details on those studies. Or speak with one of the specialists in our patient recruitment office, 1-800-411-1222.
Training Clinical Researchers
As of December 2002, 99 percent of NIH intramural principal investigators have successfully completed a required clinical research-training course, which addresses one of the Standards for Clinical Research within the NIH Intramural Research Program. Investigators must take the course and pass an exam before receiving approval to conduct new clinical protocols. All clinical principal investigators with a protocol approved through the Clinical Center are required to take the course. To date, nearly 1,400 investigators have taken the course through live classroom sessions and via the Internet. In addition to domestic U. S. locations, institutions worldwide have accessed this electronic resource including sites in Europe, Central America, Asia, and the Caribbean. The course is available here on the World Wide Web.
Conducting Clinical Research
The Clinical Center not only provides support for the various Institutes and Centers at NIH who conduct intramural research projects at our facility; we also have our own research projects, with our staff members serving as Principal Investigators. This past year NIH Clinical Center researchers were recognized for their own research accomplishments. See: NIH Intramural Research Report.
Other Clinical Research Initiatives
Standards for Clinical Research
The Standards for Clinical Research, established in 2001, set forth some essential principles and processes for the conduct of clinical research in the NIH intramural research programs. A clinical standards review process using these standards was initiated in the summer of 2000.
The Bench-to-Bedside Program encourages collaborations between basic and clinical investigators across the NIH institutes in order to translate scientific findings into clinical applications. Since its inception in 1998 more than 175 proposals have been submitted and 32 projects have been funded. In addition to institute resources, a new source of funding has been identified: The NIH Office of Rare Diseases will be supporting five projects at $100,000 per award per year for two years. The projects must focus on an area of science/research directly related to a rare disease.
The Office of Protocol Services was established in 2002 to provide principal investigators with tools and applications that help simplify the entire protocol process. One such effort, ProtoType, will simplify the protocol writing process by providing recommended language cassettes for protocol and consent form use. The application will assure that regulatory requirements are met by providing help on relevant parts of the protocol and by linking to NIH Clinical Center policies.
Clinical Research Information System (CRIS)
CRIS, the Clinical Center's next-generation clinical information infrastructure, is a $60 million project that will link and support patient care, research and management. This phase of the CRIS project replaces and expands the Clinical Center's current hospital information system known as the Medical Information System, or MIS. Once complete, at least 24 distinct information systems will feed into two CRIS hubs, the Clinical Data Repository and the Clinical Data Warehouse.