Clinical research is the
scientific process to answer
research questions related to
health and disease through
clinical studies. A clinical study
involves human volunteers (also
called participants) and is
intended to advance medical
knowledge and practice. There are
two main types of clinical
studies: clinical trials (also
called interventional studies) and
observational studies. A clinical
trial involves testing
interventions such as medical
products, medications, or
procedures, whereas an
observational study observes
participants over a given time
period. More information on
clinical studies is available here.
Because medicines must be
rigorously tested and
participants closely monitored, it
usually takes about 10 years for a
new treatment to get approved.
Finding enough participants --
from all backgrounds -- remains
one of the greatest research
challenges.
Randomized - In many
studies, participants are randomly
sorted into different groups. This
allows researchers to observe the
effects of a new treatment against
a control group, which does not
receive the treatment.
Double blind - In double
blind studies, participants and
investigators don't know who
is receiving an experimental
treatment. This helps reduce bias
due to placebo effect (a
phenomenon where people experience
benefit from belief that they are
receiving a treatment, which
can't be attributed to the
properties of the treatment
itself).
Investigational - An
investigational treatment has not
yet received approval from the
FDA.
Intervention - A health
'intervention' refers to
any activity undertaken with the
goal of improving human health.
This includes interventions that
aim to prevent disease, cure or
reduce the severity of a disease,
or restore function.