Here are answers to frequently asked questions about our clinical studies.
Is it safe to take part in clinical trials?
At Alpha Science Research, we comply with US Food and Drug
Administration (FDA) regulations and are overseen by Institutional Review
Boards (IRB’s) to ensure your safety.
Will I have to pay for anything in the study?
No, in fact, you will be reimbursed for volunteering. For study medications,
laboratory or physical assessments, cutting-edge diagnostic assessments,
or expert medical care, there will be no bill. Therefore there is also no need
for medical insurance or a referral.
Is there any chance my personal information will be made public?
No. At Alpha Science Research, we pay particular attention to your
personal information such as your name, address, phone number, and e-
mail address will be kept confidential, except where disclosure is required
by law. When sharing information that we collect about you outside of
Alpha Science Research, (for example with clients who are sponsoring the
study), you will be identified at all times by a code that does not reveal your
How will I be compensated for taking part in the study?
Typically, you will be compensated in the form of a check or dollar amount
loaded onto a reusable debit card. Reimbursement is provided only to
people who are taking part in the study, so we cannot give compensation
for travel at the first consultation.
Do clinical trials offer unique medical treatments not available
Yes, some people turn to clinical trials when they have not been able to get
the help they need through typical medical care. Our studies utilize the
latest breakthroughs in diagnostic tools and methods. Therefore, people
who take part in our studies can have the utmost confidence in a diagnosis
from one of our medical doctors.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can get into a specific study.
These guidelines are called inclusion and exclusion criteria. Inclusion
criteria determine who can participate in a study, and exclusion criteria
determine who cannot participate in a study. The criteria are based on
factors such as age, gender, type and stage of disease, previous treatment
history, and other medical conditions.
What happens during a clinical trial?
The process of a clinical trial depends on the type of trial being conducted.
The clinical trial team will include doctors, nurses, and other healthcare
professionals. The professionals will check your health at the beginning of
the trial, give you specific instructions for participating in the trial, monitor
you carefully during the trial, and stay in touch after the trial is completed.
What is informed consent?
Informed consent is the process of learning the key facts of a clinical study
before deciding whether or not to participate. You will learn about a clinical
study’s purpose, duration, required procedures, and key contacts before
deciding whether or not to participate. When you decide to join the trial, you
will receive an informed consent document that includes details about the
study. You can always ask for the consent documents in different
languages than English.
What do the different phases of a Clinical Trial mean?
Clinical trials are conducted in phases. Each phase has a different purpose
and helps scientists answer different questions.
In Phase I trials, a new drug or treatment is tested in a small group of
people (20-80) for the first time to evaluate its safety. Phase I also
helps to determine a safe dosage range, and identify side effects.
In Phase II trials drugs that have already passed through Phase I
trials are further evaluated on a larger group of people (100-300). The
drugs effectiveness, safety and dosage range are further evaluated.
In Phase III trials, drugs that have already passed through Phase I
and Phase II are evaluated on very large groups of people (1,000-
3,000). These trials are designed to confirm treatment effectiveness,
monitor side effects, compare the treatment to commonly used
treatments, and collect information that will allow the treatment to be
In Phase IV trials, post marketing information on the drug is collected.
Additional information is collected on the drug’s risks, benefits, and
What are the risks of participating in a clinical trial?
There may be unpleasant, serious, or even life-threatening side effects to
the treatment. The treatment may not be effective for the participant. The
protocol may require more time and attention from the participant than a
non-protocol treatment, including trips to the study site, more treatments,
hospital stays, or complex dosage requirements.
What are side effects and adverse reactions?
Side effects include any undesired actions or effects of a drug or treatment.
Negative or adverse effects may include headache, nausea, hair loss, skin
irritation, or other physical problems. Experimental treatments must be
evaluated for both immediate and long-term side effects.
Any potential side effects from a drug under study are explained to you during your medical visit?
Many studies involve already-marketed drugs whose potential side effects are well-known. However, it is important to mention that most side effects are short-lived and the volunteer is responsible for reporting any new side effects.
What should I consider before participating in a trial?
You 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 may be helpful to discuss with the health care team.
What is the purpose of the study?
Who is going to be in the study?
Why do researchers believe the new treatment being tested may be
effective? Has it been tested before?
What kinds of tests and treatments are involved?
How do the possible risks, side effects, and benefits in the study compare with my current treatments?
How might this trial affect my daily life?
How long will the trial last?
Will hospitalization be required?
Who will pay for the treatment?
Will I be reimbursed for other expenses?
What type of long-term follow up care is part of this study?
How will I know that the treatment is working? Will results of the trials
be provided to me?
Who will be in charge of my care?
What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?
There are many ways that you can prepare to meet with the research
coordinator or doctor. Plan ahead and write down possible questions to
ask. Ask a friend or relative to come along for support and to hear
responses to the questions. Bring a tape recorder to record the discussion
to replay later.
Who monitors and approves clinical trials?
Every clinical trial in the U.S. must be approved and monitored by an
Institutional Review Board (IRB) to make sure the risks are as low as
possible and are worth any potential benefits. An IRB is an independent
committee of physicians, statisticians, community advocates, and others
that ensure that a clinical trial is ethical and the rights of study participants
are protected. All institutions that conduct or support biomedical research
involving people must, by federal regulation, have an IRB that initially
approves and periodically reviews the research.
Will participants work with a primary health care provider while in a trial?
Yes, by having the healthcare provider work with the research team, the
participant can ensure that other medications or treatments will not conflict
with the protocol. However, most clinical trials provide short-term
treatments related to a designated illness or condition, but do not provide
extended or complete primary health care.
Can I leave the clinical trial after it has begun?
Yes, a participant can leave a clinical trial at any time. When withdrawing
from the trial, the participant should let the research team know about it,
and provide the reasons for leaving the study.
Where do the ideas for clinical trials come from?
The ideas for clinical trials often come from researchers. After researchers
test new therapies or procedures in the laboratory and in animal studies,
the treatments with the most promising laboratory results are moved into
clinical trials. During successive phases of trials, more and more information is gained about a new treatment, its risks, and how well it may or may not work.
Who sponsors clinical trials?
Clinical trials are sponsored or funded by a variety of organizations or
individuals such as physicians, medical institutions, foundations, voluntary
groups, and pharmaceutical companies. In additions to federal agencies
such as the National Institutes of Health (NIH), the Department of Defense
(DOD), and the Department of Veteran’s Affairs (VA). Trials can take place
in a variety of locations, such as hospitals, universities, doctor’s offices, or
What is a protocol?
A protocol is a study plan on which clinical trials are based. The plan is
carefully designed to safeguard the health of the participants as well as
answer specific research questions. A protocol describes what types of
people may participate in the trial; the schedule of tests, procedures,
medications, and dosages, and the length of the study.
What is a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value.
In clinical trials, experimental treatments are often compared with placebos
to assess the treatment's effectiveness. In some studies, the participants in
the control group will receive a placebo instead of an active drug or
What is a control or control group?
A control is the standard by which experimental observations are
evaluated. In many clinical trials, one group of patients will be given an
experimental drug or treatment, while the control group is given either a
standard treatment for the illness or a placebo.
What are the types of clinical trials?
There are different types of clinical trials:
Treatment trials test new treatments, new combinations of drugs, or
new approaches to surgery or radiation therapy.
Prevention trials look for better ways to prevent disease in people
who have never had the disease or to prevent a disease from
returning. These approaches may include medicines, vitamins,
vaccines, minerals, or lifestyle changes.
Diagnostic trials are conducted to find better tests or procedures for
diagnosing a particular disease or condition.
Screening trials test the best way to detect certain diseases or health
Quality of Life trials (or Supportive Care trials) explore ways to
improve comfort and the quality of life for individuals with a chronic
Is it true that the higher the compensation amount, the higher the risks?
No. The compensation amount is not determined based on potential risks,
but on the inconveniences associated with a study, such as time spent at
our facility, frequency of visits, restrictions imposed, etc.
Can I participate in several studies during one year?
Volunteers may participate in several studies but not at the same time. You
must respect a waiting period between studies for safety reasons (usually
between 30 and 56 days).
For more information about clinical trials, visit ClinicalTrials.gov, CenterWatch.com, and CISCRP.org