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.
Clinical Trial Safety
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
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
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.
Updated January 2015