Biomedical Engineering Reference
In-Depth Information
of IT by offi ce-based physicians is essential for the delivery of care in the
long term.
The topics covered in this chapter are clinical trials in general, challenges
and areas for improvement for clinical trials, and technologies to be leveraged
to address the challenges.
The chapter starts with an overview of clinical trials and key challenges for
successful trials based on the publically available information through the
Internet, specifi cally the public websites for the U.S. Food and Drug
Administration (http://www.fda.gov/), the U.S. National Institutes of Health
(http://health.nih.gov/), and the UK National Health Services (http://www.nhs.
uk/), among others.
Then, the concept of online collaboration approaches and mechanisms will
be discussed, such as social computing and virtual workplace and benefi ts with
leverage of IT and the global network infrastructure, the World Wide Web,
and the Internet.
Finally, there is a discussion of how some of the selected technologies, such
as weblogs, virtual workplace, and secure e-mail, can help address the chal-
lenges for higher effi cacy and effi ciency through optimization of the processes
associated with clinical trials.
18.2
WHAT IS A CLINICAL TRIAL?
Clinical trials are research studies that involve patients or healthy people and
are designed to test new treatments. The new treatments cover a wide range
of health care approaches, including drugs, vaccines, other approaches to
disease prevention, surgery, radiotherapy, physical and psychological therapies,
educational programs, and methods of diagnosing disease.
The U.S. Food and Drug Administration defi nes clinical trials as a research
study to answer specifi c questions about vaccines or new therapies or new
ways of using known treatments. The U.S. National Institutes of Health defi nes
clinical trials as a research study in human volunteers to answer specifi c health
questions. The UK National Health Services [1] defi nes clinical trials as
research studies that involve patients or healthy people and are designed to
test new treatments.
In this context, treatments refer to a wide range of health care approaches
that can be tested in a clinical trial, including drugs, vaccines, other approaches
to disease prevention, surgery, radiotherapy, physical and psychological thera-
pies, educational programs, and methods of diagnosing disease. Interventional
trials determine whether experimental treatments or new ways of using known
therapies are safe and effective under controlled environments. Observational
trials address health issues in large groups of people or populations in natural
settings.
Each institution defi nes clinical trials in a slightly different way, but the main
objective of a clinical trial is the same in the sense that it is to test if a new or
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