What is a clinical trial?
trial is a research study in which patients may volunteer to take part. The
Stem Cell Center (SCC) at the Texas Heart Institute uses clinical trials to
further the understanding of stem cells in relation to heart disease.
trials are part of a long, careful process, which may take many years. First,
doctors study a new treatment in the lab. Then they often study the investigational
treatment in animals. If a new research treatment shows promise, doctors then
test it on people. Doctors do this in three to four steps, or phases. Phase I
trials test to see if an investigational treatment is safe in people. Phase II trials test for efficacy. Phase III trials test if a new treatment is
better than a standard treatment.
Finally, the goal of Phase IV trials is to find more information about
long-term side effects.
Is it safe?
Cell Center's most important job is to ensure the safety of patients.
First, the SCC ensures patient safety by following well-planned, FDA approved
protocols. A protocol:
- Explains the treatment plan
- Lists the medical tests patients will receive
- Gives the number of patients who will take
part in the clinical trial
- Lists eligibility criteria, which are guidelines
to decide who may join the clinical trial
- Explains safety information
SCC ensures patient safety by using a careful informed consent process.
Institutional Review Boards (IRBs) protect patients by reviewing protocols and
monitoring trials. The IRBs are committees of doctors, nurses, chaplains,
social workers, lawyers and patients. They make sure that trials follow federal
laws and that patients are protected.
Food and Drug Administration (FDA) audits the IRBs' files. Also, FDA officials
may visit the SCC at any time and review anything they choose related to
Am I able to take part?
clinical trials are right for all patients. A trial may be safe for one patient
to join, but not safe for another. Each protocol has strict rules that doctors
must follow to decide who may join the clinical trial. These rules are called
eligibility criteria. This protects patients from getting treatment that may
Eligibility criteria include information about you and your
- Age and gender
- Results of medical tests
- Medicines that you are taking
- Your medical history
- Your type of heart disease
How do I sign up?
If you have
found a clinical trial that you think you want to join, please
submit a patient information form
, and an Intake Coordinator (IC) will contact
you within 3 business days. The IC will
give you an overview of the trials that are available, and answer any questions
you may have. During this phone call,
the IC will also obtain your contact information, and ask a series of questions
related to your medical history. In
order to determine eligibility for screening, a closer look at your medical
history is necessary. So, the IC will
send you a medical record release form via fax, mail, or email (or you may download and print a copy here
). Once completed, the form should be returned,
and the IC will request medical records from your doctors.
If you meet
pre-screening eligibility requirements after review of your medical records,
you will be invited to the Texas Heart Institute for a screening visit. You will first go through a process called
informed consent. The goal of informed consent is to make sure you understand
the clinical trial's purpose, plan, risks and benefits.
Coordinator will review the informed consent form in detail with you. During
the informed consent process, please feel free to ask questions. Try to bring a family member or friend to
help you ask questions and write down answers. Also, take time to make your
decision. If you decide to join the
clinical trial, you will be asked to sign the informed consent form. The
Research Coordinator will also sign the form, and you will receive a copy.
I look for on the informed consent form?
Look for the
following information on your informed consent form:
- The reason for the clinical trial (what the
doctors hope to learn)
- Who is eligible to take part in the clinical
- What is known about the type of treatment being
- Possible risks and benefits (based on what is
known so far)
- Types of tests
- How often you would need to undergo testing and
meet with the doctor
- Who pays for the costs of the clinical trial
- If the clinical trial causes you to need more
medical care, who pays for those costs
- A statement about conflicts of interest (any
direct financial benefit to the Texas Heart Institute from the sponsor of the
- A statement about how your privacy is protected
- Who to call if you have more questions
consent process does not end once you sign the informed consent form. For
example, your doctor must tell you if new risks or side effects of the
treatment are found during the trial. Also, please be sure to ask any questions
you may have at any time during the trial.
Clinical Trials FAQs
Who would be
in charge of my care in the clinical trial?
doctor and cardiologist will still care for you. In a clinical trial, you will
also have a:
Principal Investigator (PI): The PI is usually a doctor. He or she runs
the clinical trial and makes sure that the health care team follows the plan.
Research Coordinator: The research coordinator teaches patients about the trial and
collects data from patients on the trial. The research coordinator is a good
contact if you have questions during a clinical trial.
be any follow-up after the completion of a clinical trial?
would continue to see your doctor for treatment and follow-up care.
Do I get paid for clinical trial
are not given monetary compensation for enrollment into the different
studies. However, once enrolled in the
trial, patients are not charged for any therapy or monitoring that is directly
related to the research.
Would I be allowed
to quit the clinical trial?
in clinical trials are volunteers. You can choose to quit a clinical trial at
What happens if I don't meet
eligibility criteria for any of your enrolling trials?
If you don't
meet eligibility criteria for any of our trials that are currently enrolling,
we will store your contact information and medical history in a database. We will contact you if you appear to meet
eligibility for any of our upcoming trials.