| |
          
 |
Clinical Trial Phases
Clinical trials are commonly classified into
four phases for drug studies. Phase I and
Phase II studies are commonly performed for
nutraceuticals, devices and biotechnologies. Phase III studies are
performed to provide efficacy data from
larger and more diverse patient populations. If the intervention
successfully passes through the first three
phases, it will usually be approved by the
FDA. Following FDA approval and product launch,
Phase IV or Post Marketing Trials may be
initiated to gather more data. These
definitions are afforded to drug trials and
not typically to nutraceuticals. However, in
keeping with both strict and quality
scientific protocol, we conduct all our
studies using these trial phase regulations.
Phase I (Pharmaco-kinetic/Safety Study)
Phase I studies are designed to
establish the effects of a new intervention
in humans. These studies are usually
conducted on small populations of healthy
human volunteers to specifically determine
an intervention's safety, including
assessment of toxicity, absorption,
distribution and metabolism.
Phase II (Pilot Efficacy Study)
After the successful completion of
Phase I trials, a treatment is then tested
for safety and efficacy in a larger
population of individuals who are afflicted
with the disease or condition for which the
treatment was developed.
Phase III (Efficacy Study)
The third and last pre-approval
round of testing of an intervention is
conducted on large populations of patients.
Phase III studies usually test the new
treatment in comparison with the standard
therapy currently being used for the disease
in question. The trial results are usually
combined into a large document containing a
comprehensive description of the methods and
results of human and animal studies,
manufacturing procedures, formulation
details, and shelf life. This collection of
information makes up the "regulatory
submission" that is provided for review to
various regulatory authorities for marketing
approval.
Phase IV (Post Marketing Study)
A “Post Marketing Study” or Phase IV is designed to: 1) monitor a therapy's long-term effectiveness, safety and impact on a patient's quality of life, 2) compare the effectiveness and safety of the therapy with other therapies already in the market or 3) determine the cost-effectiveness of a therapy relative to other traditional and new therapies.
|
|
      |
|
| |
|
|
