about CLINICAL TRIALS
FREQUENTLY ASKED QUESTIONS (FAQS)

What is a clinical trial?
How are new drugs (medications) developed?
Why should I participate in clinical research?
Why should minorities and women participate in clinical trials?
How are my rights protected? How do I know I won’t just be a “guinea pig”?
What is informed consent? Why is it important?
What kinds of clinical trials does Community Research Initiative (CRI) have to offer me?
What questions should I ask if I’m considering participating in a trial?
How can I find out more about clinical trials?

What is a clinical trial?
“Clinical trial” is the scientific term for a test or study of a drug or medical device in order to see if it is safe and effective for people to use.

How are new drugs (medications) developed?

As with any type of new medical device, new drugs go through many rounds of testing. First, they are tested extensively in animals. If they perform well, the Food and Drug Administration (FDA) begins testing the drug in humans. In a Phase I clinical trial, a small number of healthy volunteers take the drug to determine its safety. Next, during a Phase II trial, scientists look at a larger group and compare the effects of the drug to either a placebo or a standard treatment. A Phase III study is a large-scale study, often involving several thousand volunteers, that provides a better understanding of the drug's risks and benefits. Some drugs also undergo Phase IV studies comparing them to other available drugs or tracking patients to observe long-term effects.

The FDA considers the data from all these types of trials before approving a new drug or treatment.

Why should I participate in clinical research?

People participate in clinical trials for many different reasons. Some of those reasons include wanting to:

1. Gain access to new drugs or treatments that aren’t generally available yet.
2. Improve the state of the science and help researchers better understand how to treat HIV/AIDS.
3. Work closely with a team of medical professionals who will closely track their care for the duration of the study.

Why should minorities and women participate in clinical trials?

In the past, many drugs and treatments were often tested only in white males. However, since medications can work differently in different kinds of people, it is important to consider the safety and effectiveness of treatments in ALL kinds of people. The greater the diversity of participants in a clinical trial, the better scientists understand how to help different kinds of patients.

How are my rights protected? How do I know I won’t just be a “guinea pig”?

There are many safeguards in place to protect the rights and safety of those who volunteer for a clinical trial. These protections include:

• The informed consent process – This document describes all the possible risks and benefits involved in the study (see additional information below).
• The IRB – Every step in the research process is carefully reviewed and must be approved by an independent ethics board (known as the Institutional Review Board or IRB) charged with protecting human subjects.
• Data Safety Monitoring Boards – Experts on the Data Safety Monitoring Board review study data as it is produced. If the data indicates any risk to subjects or any strong advantage to subjects on a particular treatment arm, they respond as necessary. For example, if the committee sees that a treatment is harmful, they will stop the study immediately.
• FDA inspections – The FDA, the federal agency in charge of clinical research, will inspect records and research sites periodically to make sure volunteers are protected and studies are being done correctly.

What is informed consent? Why is it important?

Before you can participate in a clinical trial, a member of the research team will carefully explain every aspect of the trial, including its purpose, duration, requirements, risks, and benefits. Following this explanation, you will be asked if you have any questions and given an informed consent document to sign.

It is important that you understand and are comfortable with all the information in the informed consent document. You should feel free to ask as many questions as you want before signing. This document is not a contract; even after you sign, you are free to withdraw from the study at any time without facing penalties.

What kinds of clinical trials does Community Research Initiative (CRI) have to offer me?

Please click here to see a full list of CRI’s open & enrolling trials or to search our database for trials that might fit your needs.

What questions should I ask if I’m considering participating in a trial?

If you are speaking to a doctor or study coordinator about a trial, you might want to ask some of the following questions:

• What is the reason for the study? What are you trying to find out?
• What kinds of tests and exams will I have to take? What is involved in each kind of test?
• How often will I have to visit the office or clinic site?
• How long will the study last?
• What are the possible risks and side effects?
• What are the possible benefits of the study?
• What happens when the study ends? If I want to, can I continue the experimental treatment after the study ends?

How can I find out more about clinical trials?

For more information on clinical research and clinical trials, we recommend that you visit the following sites:

http://www.hivinfosource.org/hivis/hivbasics/clinicaltrialbasics/index.html - Questions and answers about clinical trials from the Center for AIDS Research at the NYU School of Medicine

http://www.thebody.com/treat/clintri.html - “The Basics” about AIDS clinical trials from thebody.com

http://www.fda.gov/oashi/clinicaltrials/default.htm - Information for consumers and patients about clinical trials from the U.S. Food & Drug Administration