Prospective Clinical Trials
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Authors
Davis, Robert P. (Pat)
Issue Date
2004
Type
Thesis
Language
en_US
Keywords
Alternative Title
Abstract
Properly designed and executed clinical trials are the best-known mechanism by
which the safety and efficacy of new treatments and competing strategies can be
evaluated. In the United States, numerous individuals and institutions are involved in the
design and implementation of clinical trials. Although much of clinical research is
performed in traditional academic settings, a significant amount of research is now being
conducted through community-based medical centers. Carolina Neurosurgery and Spine
Associates (CNSA) is one of the nation's largest community-based neurosurgical groups.
The physicians of CNSA conduct a variety of clinical trials related to neurosurgical
diseases and a number of those trials were active during a ten week internship under the
guidance of Anthony L. Asher MD F.A.C.S. One of the group's most complex trials
involves the administration of a recombinant immunotoxin known as hIL13-PE38QQR
(IL-13 PE) to brain tumor patients. IL13-PE has been shown to possess specific anti-tumor
activity against a variety of cell lines, including malignant primary brain tumors.
This protocol, like other research studies involving human subjects, is conducted
according strict moral and ethical principles defined over the last 60 years by
international convention. While working under Dr. Asher, an intimate understanding of
the basic aspects of clinical research was established. The following composition is
intended to provide a summary of the most essential concepts assimilated during this
internship. Specifically, an outline of the basic scientific, regulatory and ethical principles
that currently guide clinical research efforts is presented here. Additionally, a summary of
the IL-13 protocol is offered as a practical example of how research studies are
implemented.
Description
ii, 50 p.
Citation
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License
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