1. As students enter the classroom, have the following
quiz up on an overhead: (The Quiz is available at http://www.webmd.com/content/pages/13/65957.htm?z=1104_08950_8900_ct_22.)
students 5 minutes to answer the questions on a new page
in their notebooks, and also have them write
a question that they have about this quiz.
Take the quiz off of the overhead and have them take
a few minutes to come up with two more questions
have them write these questions down in their notebook
Then provide students with the following scenario: You’re in the waiting
room at the doctor’s office for your annual check up when you see the following
(place overhead for them to see):
Clinical Trial Overhead
you have Asthma? The Asthma and Allergy Center of the University
of Fantastic Health is seeking volunteers for a study involving
a new treatment, approved by the FDA, for allergic asthma.
Volunteers should be male or female, ages 16-40, and have
asthma requiring treatment within the last year. Participants
must be willing to participate in a five month study with
clinical visits every three weeks. For further information,
call 555-5550 or email firstname.lastname@example.org . Financial
compensation up to $1500 will be provided when volunteers
complete the study. Dr. Maria Ruiz, Principal Investigator.
Asthma and Allergic Disease Center, University of Fantastic Health.
5. After reading
the overhead, tell the students,“Imagine you have
asthma. This study sounds interesting, especially if it
is something that can help you manage your asthma, plus
the idea of $1500 is very appealing. What questions would
you have for Dr. Ruiz? What is important to know before
you start a study like this?”
6. Explain to the students that this is what is called
a clinical trial.
7. Ask for a show of hands about who has never heard
the term “clinical trials” before. Of those who did
not raise their hands, ask “In what context have you
heard the term before?”, “What do you think the
term means?”, “Is there only one type of clinical
Using whatever parts of their answers you can, explain
that clinical trials are used to test the
and safety of new procedures and drugs. The trials
may test specific treatment regimes (amount of
of treatment, etc.) and follow a very specific
timeline that is based on results. The following
is from: http://www.webmd.com/content/pages/13/65814.htm?z=1104_08950_8900_ct_01,
which should be read by the teacher in its entirety
to help conduct this lesson effectively.
The FDA groups clinical trials into four phases. Each
of these different phases addresses a separate research
I: First, researchers test a new drug or device in about
20-100 healthy volunteers to determine whether
it is safe and what side effects it may have. Researchers
also study how long the drug stays in the body, which
helps them decide what doses to test further. Phase
I studies primarily address the question of safety.
Next, researchers test the new drug or device in about
100-300 people to determine
not it works and to learn more about possible
Phase II studies address safety and effectiveness
III: Researchers compare the new intervention
to current standard therapy to learn whether it offers
advantage. In a Phase III study, several
hundred to several thousand people receive the new
drug or device. The FDA
will only approve drugs that complete Phase
III testing. Phase III studies effectiveness.
IV: To monitor long-term side effects, effectiveness,
and other potential uses, researchers
continue to study new interventions after they are
approved and in regular
use. “Phase IV studies address
long term safety and effectiveness.
It is important to realize that this is
just the human portion of an experiment.
Clinical trials on humans
only happen after a good amount of
research in preclincal trials has already shown
that a given experiment may
be effective. Animal trials as well
as laboratory studies using cell lines and
other non-whole organism methods
precede these studies.
Ask students why animal trials might be used
instead of human trials.
them list what they see are
the pros and cons of animal trials.
is helpful to use a specific
may get stuck on the ethics
of animal trials. While this
is a very important issue in
animal trials, what it doesn’t
address is cost/benefit, and the
cost/benefit is based on what you
can gain from
such studies. Try to steer
the class towards differences and
similarities in animal and human
systems. This might
be best attempted by asking
which they consider to be a better
animal model for a study- lizard
or mouse- and
to explain why.
With the class, address the
following topics: inclusion and
exclusion criteria, placebos, informed
consent and control group. Given
what they now know about clinical
trials what can they say about
the example of a study given above?
Where on the clinical trial timeline
is this study? (The study is most
likely a Phase IV as it already
has FDA approval)
Take 10 minutes to field questions
from students. Encourage them to
refer to the questions they came
up with from the initial quiz.
12. Pass out articles to student
13. Instruct the students to
scan/read their articles. What
questions do they
have about these clinical trials?
Do they understand what is
Tell the students that over the
next few days they will
be exploring the
subject of all these clinical trials,
the skin. The students are to use
the next few days to develop
a better understanding
about the topic of skin, cancer
and UV radiation so that
they can describe
the particular study that their
news article is about.
14. Direct them to reread that
article and to write down at
least 3 questions
that they will need to address
in order to better understand
students should read their article and
write down at least 3 questions that
they need to address in order to understand
the study they are reading about.