Volunteer Study Subject
Thank you for visiting us. More than likely, you came upon
our site because you are interested in clinical trials.
If you are interested in being a participant in a clinical
trial, we strongly encourage you to gain as much understanding
as possible about participating. You can start by reviewing
our About Clinical
Trials information on this page. We have also
included responses to some questions you may have as well
as links to other resources where you can gather additional
information.
SMO-USA, Inc. maintains a secured database of potential
study participants. Should you wish to be included in this
database, please complete and submit the Volunteer
Database Form. We take very seriously your
privacy. Any information you provide to us is kept in the
strictest of confidence and will only be used for the sole
purpose of matching your clinical trial participation interests
to present and future volunteer opportunities. If you do
not feel comfortable submitting your information online,
you can always contact
us to discuss your particular interests and
provide us with the information we need to include you in
our database.
We are always available to answer any questions you may
have. Just give us a call.
The Volunteer
Database Form is also provided in Adobe's Portable
Document Format (PDF). To view these documents, you will
need Adobe Acrobat Reader, if you do not have it, follow
the link to the bottom to download a copy.
About Clinical Trials
Before a pharmaceutical company can perform a clinical
trial in humans, they must first complete very comprehensive
research in the laboratory, on human cells, and animals.
If, after this extensive effort, they wish to proceed, they
must apply for, and receive, approval from agencies within
the federal government. There are typically four (4) phases
in the process of testing, receiving governmental approval,
and marketing/selling of a new drug or medical device.
Phase One: This phase/study focuses mainly
on evaluating a drug's safety. A relatively small group
of volunteers participate in this study to assist in determining
what the drug does when it is in the body. It also assesses
any side effects associated with the drug. Approximately
three out of four studies will pass this testing phase.
Phase Two: Involving a larger number of
patient volunteers (usually up to several hundred), this
phase evaluates the effectiveness of the drug. There are
usually two groups of patient volunteers in this study;
one that receives the study drug, and another that receives
a "placebo" or standard method of treatment. Both
groups are then compared to each other to determine the
study drug's effectiveness and safety. About one out of
three investigational drugs are successful in completing
Phase One and Phase Two studies.
Phase Three: This phase involves an even
larger number of patient volunteers (upwards of several
thousand) to further gather and evaluate important data
regarding the study drug's possible side effects and effectiveness,
usually referred to as "efficacy and safety".
With some study drugs, this phase can last several years
to complete. After successfully completing this phase of
testing, a pharmaceutical company can make application to
the federal government to market and make available for
sale the drug. About nine out of ten drugs successfully
complete this phase.
Phase Four: This phase usually involves
further evaluation of the study drug in a variety of ways.
This could include the ongoing safety and efficacy in a
larger patient population, compare the drug to other, similar
drugs already in the marketplace for cost-effectiveness
and similar benefit, and the overall long term effect of
a patient's condition and quality of life.
Questions You May Be Asking Yourself
Why would I want to participate in a clinical trial?
You may wish to participate in a clinical trial for a variety
of reasons. It can be a very rewarding and satisfying experience
as well as providing you an opportunity to contribute to
the development of new and "cutting edge" medical
treatment. Study participants will usually receive close
and comprehensive medical attention from highly skilled
professionals who are readily available to answer any questions
you have or if you experience any side effects. Many times
you will receive diagnostic testing, examinations and treatment
without charge, depending on the study. This can help offset
expenses that otherwise would make it difficult for you
to receive without insurance coverage.
What is it like to be a volunteer in a clinical
trial?
Participation in a clinical investigation takes a commitment
on your part as well as the physician and nurses working
with you. They take your participation very seriously. You
will make regular appointments to see your physician and
receive a high level of personal attention. You will be
given all the time necessary to answer all of your questions
so you have a complete understanding of the study.
Some questions you may want to consider asking
when discussing your possible participation in a study
- What is the purpose of the study? What does the pharmaceutical
company hope to learn from the study?
- What is the length of time I am being asked to spend
participating in the study?
- What are the potential side effects, risks and benefits
to me?
- Are there alternative treatments available? If so, what
are they?
- What kind of treatment/medication will I be given?
- What medical options are available to me should I be
unable to complete the study?
Are my rights as a person/volunteer protected?
ABSOLUTELY. Aside from knowing that a study cannot begin
without governmental approval, an independent group of professionals
called an Institutional Review Board (IRB) also must approve
the study before it can be initiated by your physician.
An IRB is a group of medical and non-medical professionals
whose primary responsibility is to review the study to make
sure it poses no undue risks to the study participants.
Your physician is also required to provide the IRB with
periodic reports while the study is being conducted. Additionally,
your medical records are held in the strictest confidence.
It is also important to know that you may terminate your
participation at any time without jeopardizing your access
to other medical treatment.
How do I know if I'm eligible to participate in
a clinical trial?
Every study has a different purpose and a specific question
it is trying to answer. In order to do that, very specific
criteria, or requirements, are developed in order to evaluate
an individual's ability to participate. After agreeing to
be assessed for participation, you will undergo a very detailed
screening process to determine your eligibility to participate
in a study.
How can I be considered for a study? How do I find
out about available studies?
There are many forums to identify ongoing clinical drug
trials. You can ask your personal physician, your local
medical center, hospital, or University. There are many
websites available as well that list clinical trials. You
can also contact us to inquire as to what studies we are
currently seeking volunteers for, as well as register
with us for upcoming studies.
Links
We encourage the reader of this section to seek additional
information from other sources related to clinical trials.
We recommend:
Information About Clinical
Trials
Information from the Federal
Agency overseeing clinical drug trials
Information about Institutional
Review Boards
Information from the Pharmaceutical
industry
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