What is a clinical trial? 

A clinical 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.   

Clinical 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 

The Stem 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 

Second, the SCC ensures patient safety by using a careful informed consent process. 

Third, our 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.

The U.S. 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. 

Patient Eligibility

Not all 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 harm them. 

Eligibility criteria include information about you and your overall health: 

• Age and gender 
• Results of medical tests  
• Medicines that you are taking 
• Your medical history 
• Your type of heart disease 

FAQs 

Who would be in charge of my care in the clinical trial? 

Your primary 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. 

Would there be any follow-up after the completion of a clinical trial? 

Yes, you would continue to see your doctor for treatment and follow-up care. 

Do I get paid for clinical trial participation? 

Patients 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? 

All patients in clinical trials are volunteers. You can choose to quit a clinical trial at any time.  

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