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How Do Clinical Trials Work?

for Veterans and the Public

How do clinical trials work?

Before you start a clinical trial, you will go through a screening process. This is to make sure that it is safe for you to start taking the medicine. The staff will ask you about your health history, and you may have a blood test, urine test, or others (such as a physical exam or a heart test).

Who can join a clinical trial?

There are many types of clinical trials. For example, some trials are for people who have never been on anti-HIV medicines, others are for people whose treatment isn't working and who need a new medication. Not everyone can join a trial, though. Most clinical trials have eligibility criteria. These are rules about who can participate, based on health, age, and maybe other things. For example, some trials take only people who have a particular viral load or CD4 count. Usually, you can't participate in a clinical trial if you have any conditions are using medicines that might make it hard to measure how well the test treatment is working. You also cannot participate if the test treatment might harm you.

If you do qualify for a trial and decide to participate, you should be willing to follow the guidelines of the study.

What is informed consent?

You will also go through a process called informed consent. The doctors and nurses will explain exactly what will happen during the clinical trial. They will answer your questions and tell you about the risks and benefits of the clinical trial. They will ask you to sign a document called a consent form. When you sign this form, you are saying that you understand what is going to happen and that you agree to participate. Even after you have started a clinical trial, you are free to quit at any time for any reason. Quitting early will not affect your medical care in the future.

Does it cost anything to participate?

No. It will not cost you anything because you are helping the researchers to test a new medicine. Sometimes you may even get extra money to pay for your time or travel.

Who pays for clinical trials?

Trials are paid for by government agencies, pharmaceutical (or drug) companies, individual doctors and hospitals, or clinics. The doctors and nurses will tell you who is paying for the study before you begin a trial.

How long do clinical trials last?

Clinical trials can last from a few weeks to several months. After the treatment is over, they will usually ask you to come back for some follow-up visits. The follow-up period may be as short as a few weeks or as long as six months and helps to make sure that you are safe.