“Volunteers needed for allergy research study. Children (2-11 years old)”
“Are you taking more than one oral diabetes medication?”
“…Recruiting patients with epilepsy that is not controlled with current medications…”

These are ads to recruit people to take part in clinical trials. Maybe you have heard these phrases on the radio, or read them in a newspaper. These are just a few that have been posted to The Washington Post ( April 12, 2005 , F8). You may have heard of clinical trials, but do not know what they are or what takes place when people sign up for them.

 What is a clinical trial?
A clinical trial tests the safety and effectiveness of a research drug or medical device in a small group of people before the public can use it. These trials help find new treatments and cures for diseases and determine whether the new drug or medical device is safe for doctors to prescribe to their patients.

We now know that drugs may act differently in different people. Sometimes a different dose is even required. Many years ago, drugs being tested in clinical trials were only tested in adult, white males. Today, clinical trials now include women, different races, and sometimes children.

Pros and Cons
There are many pros and cons when thinking about taking part in a clinical trial. Here are some of the benefits you might get from taking part in a clinical trial:

• You have tried many different treatments and none of them worked for you. The new treatment may help you.
• You could get a new, more effective treatment that is not yet available to the public.
• You will be helping scientists learn more about your disease.
• Your results may help other people in the future.
• You could be paid to be in a clinical trial.

While there are some benefits to taking part in a trial, it is also important to know that there are some risks:  

• Because the treatment is new, you will not know which side effects will occur. This means you and your study doctor will have to watch for early signs of possible side effects.
• In most trials, some people will get the study medicine while other people will get a different medicine or a placebo (sugar pill). You cannot choose which group you are in.
• It might take time and effort because your study doctor may need to do tests to find out how well the medicine is working and to check for side effects. You might have to spend overnight stays in the hospital or testing facility to be observed.
• The treatment might not work.
• Your insurance provider might not cover all the costs.

You are protected
Not long ago, some scientists did experiments on prisoners, people in institutions, and even regular citizens, without their permission. The government, scientists, and ethicists decided that this was not ethical. They decided that scientists must ask people if they want to be part of an experiment. Before a drug can be tested in people, it must go through rigorous laboratory and animal tests. A study team made up of professionals like physicians, nurses, pharmacists, counselors, and study managers design a study. Their first concern is to make sure that you are protected if you decide to take part in a clinical trial. Only then can the test in humans begin.

When someone tries to recruit you for a trial, you will be asked to read and sign an informed consent. During this process, you will learn all the key facts of the study, such as:

• Why the research is being done.
• The requirements to take part in the study.
• Procedures that will be done during the study.
• How long the trial will last.
• Other treatments that might be available.

You can take the documents home and discuss them with your family. You can ask questions about the study before you start the trial, during, and after the trial is over. You can also decide not to take part in the study, or even leave the study if you choose. It is very important to feel that you can be open with your study doctor and other members of the team. If you forget to follow some of the instructions or forget to take some of the doses, you need to feel that it is okay to tell the doctor this. The researchers are depending on you to tell them if you have any problems with the treatment so that they will know how to help other patients in the future. Other organizations that oversee protection of study participants are the Office for Human Research Protection (OHRP), which is part of the Department of Health and Human Services, and the Food and Drug Administration (FDA).

Being part of a clinical trial can be a rewarding experience. It might give you first access to a new, improved treatment before anyone else. It is also a great opportunity to help other people for years to come.