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Clinical Trials FAQ

What are Clinical Trials?                                                                                           

Clinical Trials are studies that are done to determine better methods of treating, preventing, and managing diseases as well as gaining a deeper understanding of the disease process.  They are a key tool in determining if a new drug or medical device is safe and effective. Often, they find new uses for an existing drug or drug combination and their outcomes can positively impact the quality of life for many disease sufferers.

Are clinical trials safe?

The same ethical and legal codes that govern medical practices apply to clinical trials.  They are heavily regulated by the FDA, the Department of Health and Human Services, and Independant Review Boards which are assigned to every study.  These regulatory bodies ensure that the rights of the participants are protected, that they are not subjected to unreasonable physical or emotional harm, and that their information remains confidential. They make sure all risks are kept to a minimum and that they are worth any potential benefits.

What is Informed Consent?

It is required that the study subeject is informed of any possible risks and/or benefits that may result from participation in the trial, as well as any available alternative forms of treatment.  This information will be in the Informed Consent Document that a member of the study team will go over with you.  Any questions you may have regarding the study should be addressed prior to signing the document.  The Informed Consent Document will include:

  • The purpose of the study
  • Any procedures that will be involved during the study
  • Any possible benefits and/or risks of taking part in the study
  • Your rights as a study participant
  • A statement that taking part in research is your choice
  • What are any available alternatives for treatment
  • How any new study information will be communicated to you that may cause you to change your mind about participation

Do not agree to take part in the study until you clearly understand the process and feel comfortable in participating. You are encouraged to consult your primary care physician, family members, or friends.  

Who can volunteer?

Each trial has a different set of criteria that determines if you are eligible to participate in that trial.  If you are interested in a particular study, you can contact the Research Department and they can go over the criteria to determine if that study is right for you.

What are my rights as a research subject?

As a research subject, you have the right to:

  • Not participate
  • Know the purpose of the research
  • Know what good may come from the study
  • Know what will happen to you during the study
  • Know any possible risks vs. benefits
  • Be informed of any alternative forms of treatment
  • Leave the study at any time, without penalty
  • Be informed of any new study information that becomes available
  • Ask questions

What is a Randomized Trial?

A randomized trial studies the difference between more than one type of treatment or procedure.  You will be assigned to a particular arm of the study purely by chance.  

What is a Control Group?

A control group is the standard to which others are measured.  The control group is usually given a placebo, or the standard course of treatment for an illness, while the other group(s) are given the experimental treatment. Researchers measure the difference in outcome between the different groups.

What is a placebo?

A placebo is an inactive form of treatment.  In clinical trials, placebos are compared to the experimental treatments to determine their effectiveness.

What is a Blind or Double-Blind study?

In a Blind study, the participant does not know whether they are part of the control group, or the expiremental group. In a Double-Blind study, neither the participant nor the researcher knows to which group the subject has been assigned.

What should I consider before deciding to participate?

Some things you may want to consider when deciding on whether or not to participate in a study:

  • How will participation in the trial effect my health?
  • How long will my participation in the trial last and how will if effect my daily life?
  • What kinds of tests will I have?
  • Is it possible that I may receive a placebo?
  • What happens to any study specimen that I give?
  • What happens to my confidential health information?
  • What happens if my condition worsens during the study?
  • Will I be compensated for my time?

Why participate?

Research participation is strictly voluntary.  What are some reasons you should participate in research?

  • You may benefit from cutting edge treatments that may not otherwise be available to you
  • Your condition is monitored closely during the course of the trial
  • You would be an integral part in finding new treatments and/or cures for future generations
  • Clinical trial participants are crucial to the advancement of medicine