A clinical research trial or study is a scientific
study or investigation that outlines processes to discover,
determine or verify how a new medicine, medical device or
treatment works in people. Through clinical studies with human
volunteers, doctors find new and better ways to prevent, detect,
diagnose, control, and treat illnesses.
The Association of Clinical Research Professionals (ACRP)
and the clinical research industry are working to educate
the general public about the importance of clinical research,
the vital role that volunteers play in that research, and
the information they need in order to make an informed decision
about participation.
As an experimental drug moves through the stages of development,
it is first tested in the lab. Following careful scientific
analysis of the results, it may be tested in animals. Finally,
if the drug shows promise, it may be further tested in humans.
Once a drug is tested in humans, the stage of drug development
is typically referred to as a clinical trial.
Be Informed
Clinical trials are vitally important. There is no other way
to make a precise duplication of the human body and its responses
to new medications, or to new uses of known treatments. Every
clinical trial for a drug or medical device may not lead to
a cure, but each can provide another piece of knowledge toward
solving the puzzle.
Is being a volunteer in a clinical trial a reasonable option
for you? Your decision is an important one, both for yourself
and others who may be living with a disease. You owe it to
yourself to learn everything that's involved. Depending on
the type of study, you may either be one of only a small group
of people participating in the study or one of a larger group
of individuals participating in the study. The study may take
place in a hospital, university, doctors' offices, or a community
clinic. There are four potential clinical trial phases of
drug development:
Phase I Trials: In these studies, a
drug is given to small groups of healthy people (typically 20 to 80) for the
very first time, to determine and establish safety and tolerance of the drug
in humans.
Phase II Trials: The drug is given to
larger groups (typically 100 to 200 volunteers) with the disease/condition to
further define and determine an appropriate range of doses and learn more
about drug safety and drug effectiveness.
Phase III Trials: The drug is now
given to larger groups (typically hundreds to thousands) of people to
establish efficacy and expand what is known regarding the drug's safety with a
selected dose in a broader subject sample.
Phase IV Trials: Any studies done
after a drug is approved. This is a very large group (typically thousands) of
subjects-larger than Phases 1-3 — to continue to monitor safety in larger
populations.
In any trial, you may be given a placebo, essentially something
like a sugar pill or saline injection, with no treatment value.
The use of placebos enables researchers to document the comparison
between treatment with a new drug, and no treatment at all.
Clearly, there may be some risks to participants in a clinical
trial. But the federal government (Food and Drug Administration
— FDA) has imposed mandatory safeguards and regulations,
which serve as guidelines for doctors to follow. Doctors make
a commitment to follow all FDA guidelines to ensure a person's
safety is not put at risk. Additionally, an Institutional
Review Board (IRB) or Ethics Committee, an objective group
of independent experts, must supervise the trial. The board
must approve the trial, and then monitors its operation-ensuring
that risks are as low as possible, and worth the potential
benefits.
If you're considering participating in a clinical trial,
information presented here could help guide you through that
decision-making process.
Questions derived from materials provided by: Association
of Clinical Research Professionals, Alexandria, VA
