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OCR for page 3
INIK)WCr1CN
hi In Air ur~tar~i~ of both the nor and airman
furx~ioni~ of the human body frmn the cellular too We Ear leered,
carbines win ad~var~ ~ biot~logy, have led us to He point where
a Ear of major clip: not yet conquers are within Air grasp to
prevent or Are (1~. Be possibility of vaccines to prevent malaria or
h~patitis-B viral infection, and of gene transfer therapy to Acre
inborn errors of metabolism are but a few examples of scientific
Alvarez that may <]ramati~ly affect Be natural c~r~;e of human
At; .~.
At this them of unprecedented progress in Air increase in
kneeled In the bic~i~a~ science= deal ing with dish of human
beings, there is growing cordon that progress in translating r
cations into clinically useful products, devise and pro
will be sacked or even stomped entirely because of serials pebble;
facing clinical irnrestigation and clinical investigators In the United
States (2-7, 12, 14, 17, 18, 21, 22, 24~. These pebble: include: a)
an inadequate supply Indoor inadequately trained clinical
investigators, b) lack of funding for clinical m He ~ igation, and c)
fat ure to achieve methodological advances, particularly in clinical
trials, that take into account both resource limitations and expanding
cpportuniti~c for studies of new interventions.
-this report summarizes The deliberations and recommendations of
the Institute of Medicine Committee for the Study on Resources for
Clinical Investigation. Four major areas of concern were identified.
These areas were: (1) funding of clinical investigation in the United
States; (2) training of the young clinical investigator in the United
Static; (3) resource considerations and necessary organization and
structure of clinical investigation; and (4) outcome assessment
research. Where the Committee felt it was appropriate, possible
solutions to the p emblems were suggested. For ocher areas, it was
clear to the Committee that easy answers are not currently
identifiable. In some instances this was, in part, bPrall== of lack of
appropriate and adequate data Oboe pp. 20-2l). It was the unanimous
Opinion of the Committee that The problems outlined most be
thoughtfully and vigorously addressed to prevent serious deterioration
In clinical investigation in this country.
DE:F~S
For the purposes of the Cbmmittee's deliberations, the National
Institutes of Health (NIH) provided the following definitions:
Clinical investigation is defined as that segment of clinical research
for which an investigator directly interacts with patients in either an
outpatient or inpatient setting. This definition excludes studies for
which material of human origin is obtained through a third party and
for which an investigator has had no direct interaction with Be
patient.
3
Representative terms from entire chapter:
clinical investigators