Biomedical Engineering Reference
In-Depth Information
different treatment is safe and to evaluate how well the new or different treat-
ment works. Clinical trials cover a broad range of different types of research.
For example, they are used to test new drugs, including vaccines, but also to
look at new combinations of existing medicines. In addition, they are used to
test if administering a treatment in a different way would improve its effi cacy
or reduce any side effects. And, in a nutshell, clinical trials, which are also
referred to as medical research studies, are used to determine whether new
drugs or treatments are both safe and effective and to fi nd the best way to
prevent disease and reduce the number of people who become ill; treat illness
to improve survival or increase the number of people cured; improve the
quality of life for people living with illness, including reducing symptoms of
disease or the side effects of other treatments; and diagnose diseases and
health problems.
Carefully conducted clinical trials are the fastest and safest way to fi nd
treatments that work in people. Trials are in four phases [2], where “phases”
of clinical trials refer to the different stages of clinical trials:
• Phase I tests a new drug or treatment in a small group and is mainly
aimed at fi nding out how safe a drug is.
• Phase II expands the study to a larger group of people and is aimed at
measuring the safety and side effects and also to see if the drug has a
positive effect in patients.
• Phase III expands the study to an even larger group of people and is
mainly aimed at comparing the effects of a new drug with the existing
treatment, fi nding out how well the drug works and how long the effects
last, and fi nding out how common and serious any side effects or risks
are and about any potential long-term effects.
• Phase IV takes place after the drug or treatment has been licensed and
marketed and is mainly aimed at fi nding out how well the drug works
when it is used widely as well as the long-term benefi ts and risks and
potential rare side effects.
18.3
KEY CHALLENGES OF CLINICAL TRIALS
Key challenges of clinical trials are patient recruitment and retention because
clinical trials involve a large number of people for a long time to get the results,
timely access to accurate data with assured confi dentiality, and statutory or
regulatory compliance, especially for protection of personal privacy.
One of the critical success factors (CSFs) of clinical trials is recruitment of
a large number (generally thousands) of people to take part, because the dif-
ference between the effects of different treatments is quite often small and
also the effects are heavily dependent upon the patients' characteristics, such
as hereditary traits, dietary habits, environmental parameters, life styles (e.g.,
smoking, drinking, exercise), and socioeconomic status.
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