Clinical Trials

Clinical Trials are more extensive evaluations and are an important aspect of product development.
These studies are conducted through physician offices and frequently involve evaluations in the
physician’s clinic or office.  These studies are overseen by our Investigational Review Board and are
much more extensive and involved than are Product Evaluations.  For more information on Clinical
Trials see the section on "an introduction to clinical trials".

What is a Clinical Trial?

A clinical trial is a research study that involves human volunteers to investigate medicines and new treatment
options.  Clinical trials are the most effective method in discovering successful treatments for medical
conditions. Participation in a research study is always voluntary.  In most clinical trials the treatment, office
visits, and tests are at no cost to the participant. In some cases, participants may also
be given financial compensation.  A doctor or the study coordinator at the doctor's office should share
information on participating in clinical trials and the compensation package during your first visit.

Why participate in a Clinical Trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research
treatments before they are widely available, and help others by contributing to medical research.  There are
many reasons people take part in research studies.  In many cases, it gives participants access to a
medicine/treatment that is not currently available.  If this is the case, it is always important to keep in mind that
the study is being performed to determine the safety and efficacy of the treatment, which means that there is
some information that is unknown about this treatment and it is considered experimental.  Your participation in a
study may benefit you directly by providing you with a more effective treatment, and the information collected as
a result of your participation may be eventually be used to help to other people with the same condition.  Many
research participants get satisfaction from knowing that they are part of an effort that may reduce the suffering
of others.

What happens during a Clinical Trial?

The clinical trial process depends on the type of trial being conducted.  Before a general medical history is
taken, potential participants often sign an Informed Consent Form (ICF) that explains the purpose of the study,
conditions that may include/exclude a participant, the procedures involved, risks and/or benefits, alternatives,
and the financial compensation (if applicable).  This form is designed to provide patients with all of the
information necessary to make an informed decision regarding their participation in a specific trial.  After
reading through the ICF, patients may elect to sign or not sign the document.  Patients are encouraged to ask
the doctor or the person administering the consent form any questions that may arise.  The ICF is not a
contract and participation is always voluntary.  The participant can withdraw from the trial at any time.

The staff will check the health of the participant, give specific instructions for participating in the trial, and
monitor the participant carefully throughout the trial period. Always remember, a clinical trial is most successful
when the protocol is carefully followed.

What is an Institutional Review Board (IRB)?

An Institutional Review Board or IRB approves the clinical trials.  This is an independent committee made up of
doctors, members of the general public, and others responsible for ensuring that a trial does not represent an
unreasonable risk to patients.  Trials may also reviewed by the FDA.

What should people consider before participating in a trial?

People should know as much as possible about the clinical trial and feel comfortable asking the members of the
health care team questions about it, the care expected while in a trial, and the cost of the trial.  The following
questions might be helpful for the participant to discuss with the health care team.  Some of the answers to
these questions are found in the informed consent document.

Can a participant leave a clinical trial after it has begun?

YES. A volunteer can discontinue participation at any point during the study.  When withdrawing from the study,
it is extremely important to alert the research, and provide the reasons for leaving the study.

What is a protocol?

A protocol is the study plan on which all clinical trials are based.  The protocol is carefully designed to protect
the health of the participants as well as answer specific research questions.  A protocol describes people who
may participate in the trial, the schedule of tests, procedures, medications, and dosages, and the length of the
study.  While in a clinical trial, participants following a protocol are seen regularly by the research staff to
monitor their health and to determine the safety and efficacy of their treatment.

What is a placebo?

A placebo is an inactive form of the treatment being studied that has no value. In research, experimental
treatments are often compared with placebos to investigate the experimental treatment's effectiveness.  In
some studies, the participants in the control group (the control group is the group that is given either a
standard treatment for the illness or a placebo) will receive a placebo instead of an active drug or experimental
treatment.  If a placebo is being used in the study, this will be explained in the consent form.
If you are unsure, always ask the research staff.
Product Evaluations

Product Evaluations are performed on new products as well as product improvements prior to their being
released to the general public from Ad Lunam Labs.  These evaluations are conducted to obtain input from
selected individuals regarding a wide variety of product attributes ranging from packaging to ease of
product application, and ultimate results.

If you would like to participate in our product evaluation process and/or in some of our clinical trials, please
complete our Product Evaluation - Clinical Studies Registration Form.  We will keep your personal health
information confidential.  When we have products or studies that call for someone with your skin type and
skin "history", we will contact you by e-mail.

Evaluations usually involve your at-home evaluation of a product and completion of a short on-line
questionnaire.  In some cases, the evaluation process might include a brief telephone interview by one of
our Researchers.  Product evaluations differ from Clinical Trials, but are nevertheless overseen by the
Medical Director of Ad Lunam Labs.

As part of our "research and development team", we will periodically contact you to solicit your opinions
and periodically provide you with updates on health, beauty, and anti-aging topics that we believe may
interest you.
Ad Lunam Labs Inc., 1109 Silvery Shadows Avenue, Henderson, NV 89015
Toll Free: (800) 258-3635  -  Telephone: (702) 476-0087  -  Facsimile: (330) 666-2561
© Ad Lunam Labs Incorporated, 2009
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