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Human Safety In Clinical Research Essay

605 words - 3 pages

Recently, a great deal has been
written about clinical research
involving human subjects.
Unfortunately, much of the
news has been bad—fraudulent
investigators in academia
exposed, fined, and sent to
prison;1–2 institutional review
boards (watchdog groups for ethics
and safety in research) examined
and restrained or shut down by the
U.S. government because of inappropriate
practices;3–6 a physician
failing to follow regulatory
guidelines and
treating cancer subjects
with a vaccine
manufactured with a
“lack of control;”7 the
death of a young man
in a university clinical
trial testing a gene therapy.
8 The FDA reports
that the number of
complaints filed
against clinical investigators
by their own
staff members, pharmaceutical
sponsors,
or FDA investigators
markedly increased in 1999.9
Reports and recommendations
have issued from government
agencies. The Office of Inspector
General of the U.S. Department of
Health and Human Services published
...view middle of the document...

14 Education, testing,
and accreditation for clinical
research physicians and their staff
members are being considered,
and new regulations or guidelines
for oversight of clinical research
seem imminent.15
Speaking from the highest
level, former Health and Human
Services secretary Donna Shalala,
PhD, voiced her opinion about
recent problems in the execution
of clinical research and provided
specific recommendations for
change,16 as did former FDA commissioner
Jane Henney, MD.17
The analyses and recommendations
in these reports may lead
readers to question whether clinical
research is being conducted
safely, and to ask how the welfare
of human subjects is being maintained.
The public literature contains
little about the standards and
practices in place designed to
ensure subject safety and wellbeing
in industry-sponsored trials,
18 although much, in fact, is
being done.
With this in mind, this article
describes the process of drug discovery
and development in the
pharmaceutical industry, with special
emphasis on the regulations
and practices in place to ensure
that people who volunteer to participate
in clinical research on new
drugs are treated with respect and
dignity, and that all measures are
taken to ensure their safety and
well-being. Specifically,
• What is the process of drug
discovery, research, and development
in the pharmaceutical
industry?
• What are the research standards
that protect subjects?
• How do pharmaceutical companies
ensure that human protection
standards are in place and
followed?
Core philosophy of drug
development
Patient well-being and safety are a
constant concern throughout the
long (up to 15 years), expensive
(perhaps $500 million), detailed
(about 400,000 pages in a typical
NDA) development process for a
new drug. In fact, safety is a powerful
business and marketing driving
force. The reason is simple and
practical: Unsafe or troublesome
drugs don’t remain long on the
market because they do not serve
customers well. As a result, along
with finding drugs for untreated
medical conditions, improving the
safety or side-effect profile of existing
drugs is a target of drug discovery
scientists.

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