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Clinical Trials: A Participant’s Guide

There are many reasons to participate in medical research and clinical trials. But before you do, it is important to consider whether the trial is right for you. In addition to deciding whether a trial is a good fit for you, trial investigators will also decide whether you are a good fit for their trial.

Who Can Participate?

Investigators use certain guidelines to determine the characteristics that subjects need in order to participate. Factors that allow someone to participate in a trial are called “inclusion criteria.” The factors that disqualify someone are called “exclusion criteria,” and they may include:  

  • Gender 
  • Age 
  • Previous treatment history 
  • Type and stage of a disease 
  • Other medical conditions 

Participation guidelines make certain that trial’s results will reflect the treatment that investigators are studying, rather than other factors. This helps researchers achieve meaningful and accurate results. 

Enroll in a Study

Enrolling in a clinical trial may yield significant health benefits, but there are risks involved with any experimental treatment. So if you are considering joining a study, you should educate yourself about the process, risks, and benefits. You can find out about these things from the trial coordinator, as well as from an informed consent document that you will sign before participating.  

In addition, the trial team will discuss the study with you and answer any questions you may have about the study before you make your decision about participating. 

Questions for the Clinical Trials Team

Here are some questions that might be helpful for you to ask: 

  • How long will the trial last? 
  • What kinds of treatments, tests, or procedures will I have during the study? How do they compare with what I would receive outside the study? 
  • What is the main purpose of the trial? In what phase is the trial? 
  • Why do researchers believe the treatment being tested may be effective? Has it been tested before? 
  • What are the possible short- and long-term risks, side effects, and benefits to me? How do they compare with standard treatment? 
  • Will I be able to see my own doctor? Who will be in charge of my care? 
  • Who is sponsoring the trial? 
  • Will I have to pay for any part of the trial? 
  • What is my health insurance likely to cover? 
  • What happens if I become sick while participating in a trial? 
  • Can I choose to remain on this treatment after the trial is over? 
  • How are the study data and patient safety being monitored? 
  • When and where will study results and information go? 

 If you have questions about your rights as a research study participant, please contact the Institutional Review Board. 

Learn More

Click a link to find out more about clinical trials at The University of Tennessee Medical Center. 

Contact Info
Office of Clinical Trials
1926 Alcoa Highway, Suite 344
Knoxville, TN 37920
865-305-5120 Find a Doctor Make an Appointment
Contact Info
Office of Clinical Trials
1926 Alcoa Highway, Suite 344
Knoxville, TN 37920
865-305-5120 Find a Doctor Make an Appointment
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