FAQ | ASR-2

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

identity.

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

otherwise?

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

used safely.

In Phase IV trials, post marketing information on the drug is collected.

Additional information is collected on the drug’s risks, benefits, and

optimal use.

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

community clinics.

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

treatment.

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

conditions.

Quality of Life trials (or Supportive Care trials) explore ways to

improve comfort and the quality of life for individuals with a chronic

illness.

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