Being in a Drug or Other Clinical Trial

Community-based, not-for-profit organizations related to various diseases may maintain up-to-date information about drug trials and treatment programs. Your doctor may also know about drug trials. If you or your doctor is dissatisfied with treatment that is available, he may suggest a specific trial. Some clinics run clinical trials. They have information about the trials that they are doing. Many groups conducting clinical trials advertise in the newspaper, on the radio and the Internet.

How do I join a trial?

Every trial has strict rules about who can join. The requirements of a trial are called Inclusion and Exclusion Criteria. Inclusion criteria are things you must have to join a trial; e.g. some special blood component or a particular condition or a certain age level. Exclusion criteria are things that will keep you out of a trial, such as medications that you may be taking but are not allowed to continue taking during the trial.

When you find a trial that interests you, the first step is to call the trial site. The coordinator will ask you questions. If you meet the basic requirements of the trial, they will arrange for you to visit the site for an interview. During the interview, you’ll be asked detailed questions about your health. A medical exam and some blood tests are also usually done.

During the interviews, you should ask questions like:

How long is the trial?
A trial could last from a few days to a few years.

Will I know what drug I’m getting?
In a Phase 1 trial you might. It depends on the type of trial. Ask your study doctor. In a Phase 2 and 3, you might not.

What if I get sick?
Find out who you can call for help 24 hours a day.

Should I stop visiting my own doctor if I participate in the trial?
It’s important to go to your doctor for regular checkups.

Joining a drug trial means that you agree to follow the rules of the trial. The rules of the trial are called a protocol, which explains exactly how the trial will be run.

If you don’t feel comfortable with the rules – like not being able to make all the appointments, or going to a clinic where the waiting room is full of sick people, discuss your concerns with the people running the trial. Following the rules is the only way the researchers can be sure of getting the information needed about the new drug.

Each trial has a protocol chair. The protocol chair is usually a doctor who helps plan the trial, and who is in charge of all the sites. If you don’t qualify for a trial or if you’re asked to leave because of one bad blood test, you can ask the protocol chair for an exception.

What’s it like to be in a trial?

Every trial is different, so it’s important to learn exactly what a trial requires before you participate. Everything you have to do while you’re in the trial should be carefully explained to you, including:

How will I take the drug?

In most trials you will take the drug or drugs at home. You will be told exactly when and how to take it. In other trials, you may have to take it in the hospital. A drug may be given in one or more ways:
• Intramuscular (injected into a muscle)
• Intravenous (injected in a vein)
• Subcutaneous (injected under the skin)
• Pill or liquid you swallow
• Spray you breathe in
• Cream you rub on

How often do I have to come to the site?

You may have to visit the site as little as once a month or as often as five times a week. At first, there may be many medical checkups to see what the drug is doing to you. Later in the trial there will usually be fewer checkups. Ask for a schedule so you remember your appointments.

What else will I have to do?

Every trial has different rules. For example, you may be asked to write down information at home about your daily activities, or you may be told not to eat certain foods. If you think you need help doing any of these things, ask for it. You should also know the reasons why you might be asked to leave the trial.

Will it cost me anything?

In some clinical trials, the study drug or device is provided to the patient at no charge. Other studies, particularly those investigating new uses of existing drugs, may require you (or your insurance carrier) to pay for the medication or device used.

Similarly, some clinical trials cover all study related costs, including physician visits, laboratory tests, and other relevant procedures, while other studies do not.

If you do not want your insurance company to know you are in a drug trial, talk about this with the people running the trial. If you do not have Medicaid or insurance, the site may pay for everything or may want you to pay.

Your responsibilities should be detailed in the consent form that you will be asked to review prior to study participation. If you have any questions about your financial obligations be sure to discuss this with the study investigator or their staff.

There may be other costs, like time off from work, subway fares, or baby-sitter and day care costs. Some sites will pay for these and some will not. Get the name and phone number of everyone you talk to and keep all records.

Do I need my own doctor?

Yes, joining a drug trial is not the same as having your own doctor. Drug trials are not designed to provide people with treatment, so it’s important that you have a regular doctor or clinic for regular checkups and lab tests while you are in the trial.

Who’s in charge of the trial?

The person in charge of the drug trial at each site is called the principal investigator. He or she is usually a doctor, although it could be a nurse or other clinical researcher. There is also a team of doctors and nurses who do the medical exams and the blood tests, etc.

Who protects me when I’m in a trial?

Every institution that conducts medical research involving people is required by the federal government to have an Institutional Review Board (IRB). The IRB is a group of people from various professions who are responsible for protecting the rights of people in a trial. The IRB must approve any trial being done at the institution, and periodically approve continuation of the trial.

Based on the data gathered, the IRB, protocol chair or the principal investigator can change or stop a trial that doesn’t do what it promised, exposes people to harm or if unacceptable side effects are observed. You can contact the IRB if you have a problem while in the trial.

The people running the trial will tell you how to contact the IRB. You can also contact the people in charge of the trial.

What if I get sick while I’m in the trial?

If your health gets worse while you’re in the trial, the people running the trial will try to find out if the drug is making you sick or if you’re sick for some other reason. Keep your doctor informed about everything you are experiencing.

All drugs have side effects. Many are not noticeable, but some are moderate and some may be severe. Some drugs can lead to serious illness or death. If you get sick because of the drug, tell the people running the trial. You may be either taken off of the drug or given a different amount. If the trial is comparing two drugs, you may be offered the other drug. It’s important to get the phone number of a doctor or nurse involved with the trial who you can call 24 hours a day, in case you get sick in the middle of the night . Because the drugs in trials might be experimental, a doctor in an emergency room may not know what to do if the drug makes you sick. Ask how you can be prepared if this happens. If you get sick, but not because of the drugs, you may be offered the other drug.