| What is a clinical
A clinical trial is a research study in human volunteers that seeks
to answer very specific health questions. A major component of clinical
research is the process of testing and evaluating the safety and effectiveness
of potential treatments. Carefully conducted clinical trials and drug
studies are the fastest and safest way to find treatments that work and
that may improve your health.
How are clinical trials conducted?
Clinical trials are conducted in phases. The clinical trials at each
phase have a different purpose and help scientists answer different questions:
- In Phase I trials, researchers test a new drug or treatment
in a small group of people (20-80) for the first time to evaluate
determine a safe dosage range, and identify possible side effects.
- In Phase II trials, the study drug or treatment is given to a larger
group of people (100-300) to see if it is effective and to further
evaluate its safety.
- In Phase III trials, the study drug or treatment
is given to large groups of people (1,000-3,000) to confirm its effectiveness,
monitor side effects, compare it to commonly used treatments, and
continue to collect information that will allow the drug or treatment
- In Phase IV trials, after the drug is licensed by the
Food and Drug Administration and is on the market, studies provide
additional information including the drug’s risks, benefits,
and the best ways to use it in combination with other medications.
What happens during a clinical trial?
The clinical trial experience depends on the type of trial being
conducted. The clinical trial or research team includes doctors,
nurses, and other health care professionals, and this team
works closely with
the participant’s primary care provider so that there
is continuity of care and good exchange of important information
trial. The research team checks the health of the participant
at the beginning
of the clinical trial, gives specific instructions for participation,
monitors the participant carefully during the trial, and, if
you wish, will
stay in touch with you after the clinical trial is completed.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate.
The factors, or rules, that allow someone to participate in
trial are called "inclusion criteria," and those
factors that prevent others from participating are called "exclusion
These criteria are based on such things as age, gender, the
type and stage of the disease being studied, previous treatment
other medical conditions and laboratory test results. Using
inclusion/exclusion criteria is an important principle of medical
research that helps to produce reliable and unbiased results.
It is important to note that
inclusion and exclusion criteria are not used to "reject" people
in the usual sense of the word. Rather, the criteria are technical
necessities to identify participants who are similar enough
to be compared to one another so that the study will not produce
results. Another reason for these criteria is to protect the
safety of participants by excluding those with, for example,
abnormalities that might put an individual at undue risk. In
summary, these criteria
help ensure that researchers will be able to answer the questions
reliably and at the same time protect the study participants.
Why should I participate in a clinical trial?
- You can play a more active role in your health care.
- You may gain
access to new treatments before they are widely available.
- You can help others by contributing to medical research.
at a minimum, the best available treatment.
- The research team can be a great resource for your questions
participants to defray costs for travel
I consider before participating in a trial?
You should know as much as possible about the clinical trial before
signing the informed consent document, and you should feel
comfortable asking the members of the research team any questions you
You will be given time to think about your decision, and you
will be able to take the document home to talk it over with the important
in your life.
How is my safety protected?
Clinical research is federally regulated and has built-in safeguards
to protect all participants. In addition, the ethical and legal
codes that govern medical practice also apply to clinical trials.
the ways that the safety of participants is protected is with
the oversight of an Institutional Review Board (IRB). Every clinical
trial in the
U.S. must be approved and monitored by an IRB to make sure
risks are as low as possible and are balanced by any potential
benefits. The IRB is an independent committee of physicians, statisticians,
community advocates, and others that ensures that a clinical
and that the rights of study participants are protected. All
institutions that conduct or support medical research must, by federal
have an IRB that initially approves and periodically reviews
all research projects involving humans. As a clinical trial progresses,
will report the results of the trial at scientific meetings,
journals, and to various governmental agencies. All patient
information, including the identifying factors used on laboratory specimens,
is transmitted by code numbers. Therefore, individual participants’ names
will always remain secret and are never mentioned in any reports. Another
way that the rights of study participants are protected is through
a process known as "informed consent".
What is Informed
Informed consent is the process of learning the key facts about
a clinical trial in order to make an intelligent and informed
decision about whether or not to participate. It is also a continuing
throughout the study for the research team to provide updates
and information to participants. To help someone decide whether or
not to participate,
the doctors and nurses involved in the trial will explain the
details of the study in everyday language. If the participant’s
native language is not English, translation assistance will be provided.
The study coordinator will review an informed consent document
and a research
authorization form with you. These documents include all of
details about the study, such as its purpose, duration, required
and key contacts. All known risks and potential benefits are
explained in the informed consent document. After reading them through
talking to your family or members of your health care team,
you can then decide
whether or not to sign the documents. If you decide to sign
these forms, this will be to give your permission to proceed with the
screening evaluations. Only after you sign the informed consent
authorization documents can blood be drawn or other tests performed
to see if you are definitely eligible to participate. Informed
consent is not a contract, and you may withdraw from the trial
at any time
without fear of a change in your healthcare or benefits.
What are some of the questions I should
The following questions might be helpful for you to discuss with
the research team. Most of the answers to these questions are found
in the informed consent document.
- 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
- What kinds of tests and treatments are involved?
do the possible
risks, side effects, and benefits in the study compare
with my current
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Will I be paid
for my time?
- What type of long-term follow
up care is part
- 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
How should I prepare for my appointment
with the research coordinator or doctor?
Plan ahead and write down your questions. If you would like, ask
a friend or relative to come along. If possible, bring a copy of
your medical records with your medication history, a list of any
you are allergic to or intolerant of, and your recent blood test
results such as T-cells and viral load.
What happens at my first research appointment?
Your first appointment in the research clinic will be a learning
experience for both you and the study team. At this first appointment,
also known as a screening visit, the study coordinator will review
the available studies with you in detail and will encourage you to
ask questions. At the same time, the coordinator will try to get
to know you and help you decide if you could possibly benefit from
in any of the studies that you seem to qualify for. For the next
step, the study coordinator will review the informed consent document
a research authorization form with you. The evaluations done during
the screening visit are to determine whether you meet the full inclusion/exclusion
(eligibility) criteria. In most cases, blood samples will be drawn
for laboratory tests, and the study coordinator will conduct a physical
examination. The screening visit will take about one hour. Some studies
require you to return to the research clinic for a second screening
(pre-entry) visit before actually entering the study.
Do I continue to work with my primary health
care provider while I am in a trial?
Yes, in fact, the study team works closely with the primary care
provider that is required of all study volunteers. The reason
for this requirement is that most clinical trials provide relatively
treatments related to a specific illness or condition, but do
provide extended or complete primary health care. In addition,
by having the
health care provider work with the research team, the participant
can be assured that other medications or treatments will not
the study treatments, and can also be assured of a more comprehensive
level of care than if limited to either one or the other component.
For people who do not have a primary care provider, the ACTU
can refer you to someone.
Can I leave a clinical trial after it has begun?
Yes. You can leave a clinical trial at any time without it affecting
your health care or benefits. If you decide you want to withdraw
from the trial after you have entered, you should let the research
know of your wishes, and talk to them about your reasons for
wanting to leave the study.
How do I participate
in a clinical trial?
To determine if there is a study that would be appropriate for you, speak to
your health care provider or call the Beth Israel AIDS Clinical Trials Unit at
800-483-7339 from 9:00am to 5:00pm Monday through Friday. When you call, it would
be helpful to have your recent blood test results such as T-cells and viral load
available, and, if possible, a record of your medications. The study coordinator
will answer your questions about general study requirements and help determine
if there is a specific study for which you may be eligible. Your conversation
will be entirely confidential. You do not need to give your name or telephone
number unless you want to make an appointment.
What drugs are currently approved for the treatment
list of currently-approved drugs.
Call toll free: 800.483.7339