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Clinical
research has a long history, with much of the
early experience resulting from observations before and
after a change in treatment. The earliest example
took place approximately 600 BCE when Daniel designed and
participated in a nutritional study in the court of King
Nebuchadnezzar, King of Babylon. A famous observation
was that of the Renaissance surgeon, Ambroise Paré who
ran out of boiling oil to treat battlefield injuries, substituting
instead a mixture of rose oil, turpentine, and egg yolks. To
his surprise, the next morning, the soldiers treated with
the substitute mixture were healing much better than the
ones treated with boiling oil.
The National Institutes of Health (NIH ) of the Department
of Health and Human Services (DHHS) has played
a vital role in clinical research. In 1930, the Ransdell
Act transformed the Public Health Service’s (PHS)
Hygienic Laboratory into the National Institute of Health. The
Act authorized the establishment of research fellowships
in both basic science and medical research and represented
a turning point in the public funding of medical research. Interesting
historical information can be found in A
Short History of the National Institutes of Health. Today,
the NIH is composed of numerous Institutes
and Centers and supports the largest number of clinical
trials of any governmental agency.
When The National Heart, Lung and Blood Institute
(NHLBI) was established as the National Heart Institute,
its primary purpose was to lead the national research program
in heart diseases. In 1972, the National Heart, Blood
Vessel, Lung, and Blood Act mandated an expanded program to
address all aspects of heart disease, including high blood
pressure, elevated cholesterol levels, stroke, and particular
blood diseases such as sickle-cell anemia. NHLBI has
carried out many of the largest and most complex observational
cohort studies involving thousands of patients with decades
of follow-up.
Clinical research is defined by the NIH as:
- Patient-oriented research. Research conducted with human
subjects (or on material of human origin such as tissues,
specimens and cognitive phenomena) for which an investigator
(or colleague) directly interacts with human subjects.
Excluded from this definition are in vitro studies that
utilize human tissues that cannot be linked to a living
individual. Patient-oriented research includes:
- mechanisms of human disease,
- therapeutic interventions,
- clinical trials, or
- development of new technologies.
- Epidemiologic and behavioral studies.
- Outcomes research and health services research.
Clinical research may be conducted via a grant or
contract mechanism. A grant is primarily
an award of financial assistance transferred to a recipient
to carry out a project, program or training. This
website will address the conduct of clinical research primarily
through a grant mechanism. However, many of the same
principles apply to contracts as well. A contract is a written proposal by an individual or non-federal organization,
usually in response to a request for proposals. It
consists of a technical and a business proposal, including
a description of the project and its costs, and the methods,
personnel, and facilities to carry it out. Please
go to Contract Opportunities and
Procedures for
more detail on writing a contract proposal.
Clinical research is a complex undertaking in
which policies and procedures emerge and change frequently. Clinical
research may involve many organizations outside of NHLBI, such
as the FDA,
OHRP,
DHHS and
CMS. DHHS
regulations (45
CFR 46) apply to research funded in whole or part by DHHS. FDA
regulations (21
CFR 50 and 21
CFR 56) apply to research involving products regulated
by FDA. Some clinical research funded by NHLBI may be subject
to both sets of regulations.
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