| What
Are Clinical Trials?
A clinical trial is a drug
study sponsored by a pharmaceutical or biotechnology company.
There are cases, however, where health-related government
agencies provide funding and other resources for a clinical
trial. The purpose of these studies is to find out whether
a medication is safe to use and effective against various
diseases or medical conditions. In order to study the medication,
several questions need to be answered first. For example,
what patient population or disease is the drug meant to treat?
What criteria should be used for accepting participants into
the study? What general and disease-specific information are
the study doctors going to obtain? Essentially, once these
and other important study questions are answered, the study
doctors (investigators) are chosen, the regulatory documents
are approved, and the study is ready to begin.
Why are clinical trials important?
There are a several reasons
why clinical trials are important. First, the participant
may have a positive response to the study medication, and
their disease or condition may improve. In addition, participants
receive free laboratory and medical testing. More often than
not, the study medication is in development because it works
differently than other drugs on the market, and therefore,
it may present an alternative course of treatment for the
patient. Second, participation in a clinical trial helps manufacturers
make informed decisions about whether to pursue getting a
particular drug approved by the Food & Drug Administration
(FDA). Finally, data from one patient (who completes the entire
study) can be an important part of a drug development program.
In the best case scenarios, these data can help get an exciting
new drug approved by the FDA, and ultimately, continue the
industry's efforts in developing medications that are safer,
more effective, and work faster than any before them.
How are a participant's rights
and safety protected?
The FDA is the governing agency
that develops the policies and guidelines for all medical
research, regardless of manufacturer, study phase, or drug
type. There are also independent Institutional Review Boards
(IRB) that review and approve all study-related documents,
such as protocols, Informed Consent forms, physician credentials
and eligibility, and patient recruitment materials, such as
print advertisements and public service announcements.
What are the phases of the
clinical trial process?
There are three primary phases
an investigational drug has to go through before it can be
approved by the FDA, and a fourth phase that an approved drug
may enter.
Phase I
In this phase of a clinical
trial, the manufacturer wants to find out how the drug works
in healthy study participants. Mode of action (how the drug
exerts its effects), safety, and side effects -- these are
some of the main issues that are of the utmost concern to
drug makers at this stage of the clinical trial process. It
is important to note that in Phase I studies, the overall
safety of the medication in patients has not been established.
Phase II
A drug reaches Phase II only
when the FDA has reviewed the Phase I data and concludes that
the drug is safe for patients, and that its clinical activity
may be beneficial against a particular disease or condition.
At this point, a larger group of patients are enrolled and
condition- or disease-specific rating scales are used to record
data.
Phase III
This is an important turning
point for drug manufacturers. The medication has already past
the rigorous testing and review process required by the FDA,
and now it's ready to be studied in an even larger patient
population, with even more advanced rating scales and clinical
measures. In recent years, there has been a growing industry
trend to not only measure clinical effectiveness at this phase,
but also measure "real world" results. For example,
if a patient shows clinical improvement after entering the
study, how are their activities of daily living improving
(e.g., the patient can work in the garden more often or attend
their child's games on a regular basis)? Most medications
that reach Phase III will at least be considered for approval
by an FDA advisory board.
Phase IV
At this phase in development,
the drug has already been granted FDA approval. Phase IV studies
are often performed to either identify an additional use for
an already approved drug, or to gather additional safety information
from a larger group of patients. In some cases, Phase IV studies
are implemented to establish effectiveness in a subgroup of
patients, for example, patients over age 65.
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