What is the purpose of a study?

A clinical study investigates potential new treatments to confirm whether the medicine or treatment is safe and effective for a particular disease or condition.

How are clinical studies approved?

All clinical study applications are reviewed by the U.S. Food and Drug Administration to decide if the clinical study is appropriate and if it conforms to laws and international regulations that are in place to guide clinical studies and ensure they adequately protect human participants. In addition, Institutional Review Boards (ethics committees) review studies to ensure they are conducted in accordance with all federal, institutional, and ethical guidelines.

Who is the Principal Investigator?

The Principal Investigator is a doctor at a clinic site. The doctor, with his/her team of nurses, pharmacists and other health care professionals, is responsible for overseeing the health of the study participants at all stages of the study and ensuring the clinical study is conducted correctly.

What is Informed Consent?

If the clinical site believes you might qualify for the study, you will receive an Informed Consent Form to review. The Informed Consent Form will include information on, but not limited to:
  • Eligibility criteria
  • The possibility of receiving the investigational medicine or placebo
  • Possible risks and benefits of the investigational medicine
  • The risks of any side-effects
  • Descriptions of any medical tests or procedures done in the clinical study
  • Your rights and responsibilities as a research participant
  • Your right to withdraw from a clinical study at any time, without consequence to ongoing medical care.
  • Information on how your confidential health information will be handled.
Only after careful consideration should you provide written consent to participate in a clinical study.

What are the risks from participation in a clinical study?

The investigational drug used in this and other human clinical trials has been tested in animals. All of the information known about the study drug has been used to design this study and your health will be monitored closely, but unforeseen problems could arise.

In addition:
  • The study participant may experience potential side effects from the study medicine.
  • The study medicine may not work for the clinical study participant.
  • In a placebo-controlled study like this one, the study participant may receive the placebo and not the investigational treatment.
More information will be provided in an Informed Consent Form at the first study visit.

What happens if side effects occur from taking a medicine in a clinical study?

The study participant is asked at each visit to report any change in health status. If a side effect occurs, appropriate care will be provided.

Why should I participate?

There are many reasons why you may want to participate in a study – helping others by assisting with providing important information on new treatments, getting to try new treatments, and being more proactive with options for treatment of your condition. Study participation is voluntary. You can withdraw from this clinical study at any point in time without consequences to your medical care.