FAQs

Questions

  1. What is a clinical study?
  2. What is a clinical investigator?
  3. Are clinical studies safe?
  4. Why do people participate in a clinical study?
  5. How will I know if I am eligible for a clinical study?
  6. What is an informed consent?

What is a clinical study?

A clinical trial is a research study conducted in people to evaluate a new investigational medical drug, or device. The purpose of clinical trials is to find new and improved methods of treating different diseases in the future.

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What is a clinical investigator?

A clinical investigator is a medical researcher conducting a research study. Researchers are usually doctors, nurses, pharmacists, or other medical professionals.

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Are clinical studies safe?

Clinical studies are typically conducted by a trained medical professional. An Institutional Review Board or IRB reviews all clinical studies. This is a committee made up of doctors, ethicists, and members of the general public and administrators. This group helps to ensure that the rights of research participants are protected. Your regular doctor is responsible for your well-being and you may want to speak with your doctor before agreeing to participate in a study as there are risks associated with taking any drug. Whenever you agree to enter a study, you are given the name and telephone number of a contact in your study physician's office who will answer your questions as well as a contact for the IRB whom you can contact if you have questions or concerns.

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Why do people participate in a clinical study?

There are many reasons people take part in research studies. It gives individuals a chance to receive investigational medicine not available to the public. Studies are performed to test if the investigational study drug works and to see if it is safe.

Often, the process of collecting information in the study will allow the doctor to find out more about your disease and the effects it has on you.

Lastly, a study may not benefit you directly, but the information gathered may be of help to other individuals in the future with the same condition. Many study participants derive satisfaction knowing they may be a part of this effort.

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How will I know if I am eligible for a clinical study?

You can find out about clinical studies from many sources. There are often advertisements in your doctor's office. Many clinical studies are posted on Internet pages such as this one and can be an excellent source of information. Each study has certain requirements for participation. Your study doctor will take a medical history from you and may request additional testing to determine if you are eligible according to the criteria for the study.

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What is an informed consent?

Anyone agreeing to participate in a clinical study is required to sign an informed consent document. The informed consent document provides the details about the study and explains the potential risks and benefit. In addition, the informed consent document explains your rights and responsibilities. This document will tell you what study drug may be given, what kind of side effects might occur, and what other medications might work for your condition.

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