Clinical trials are research studies involving people. They test ways to treat and prevent disease. All of today’s standard treatments are a result of clinical trials completed many years ago.

Organizations or individuals looking for better treatments or new ways to prevent or detect disease may sponsor clinical trials. Individual doctors at medical institutions can also conduct trials. Other sponsors include drug makers, technology companies, and non-profit groups. Each trial has a person in charge, usually a doctor, who is called the protocol chair or principal investigator (also called the PI). Before enrolling in a trial, ask whether the trial has been approved by an Institutional Review Board or IRB. IRBs exist at most hospitals to help safeguard patient rights.

Clinical trials testing new treatments are carried out in phases.

Phase I — Is the treatment safe?
As the 1st step in testing the research, doctors gather information about the side effects of the treatment and decide on the safe dose. Only a few patients in a few places take part in a Phase I trial.

Phase II — Does the treatment work?
In this step, doctors test the treatment to see how well it works. Most of the time, fewer than 100 patients are involved in Phase II trials.

Phase III — Is the treatment better?
Phase III trials compare the new treatment against the current standard therapy and randomly assign patients into 1 of the 2 groups. Many people from all over the country take part in these trials.

Phase IV — Are there better ways to use the treatment?
In this final step, treatments are tested to make sure they are safe and work well over a long period of time. This phase most often occurs once the new treatment has been approved for standard use. Anywhere from several hundred to several thousand people are enrolled in a Phase IV trial.

Clinical trials are available through doctors everywhere — not just in major cities or in large hospitals. Clinical trials take place in teaching hospitals, outpatient clinics, community hospitals, and doctors’ offices.

• Prevention –These trials test new approaches that doctors believe may reduce your chance of developing disease. Most involve healthy people. Some studies are conducted with people who have had an illness in the past to try to find ways to prevent relapse
• Screening – Since illnesses are often easier to cure when found early, screening trials test methods to better detect them, especially in the early stages
• Diagnostic – Diagnostic trials test new approaches that could be used to identify certain diseases and at an earlier stage
• Treatment – The purpose of these trials is to find out if a new treatment or technique is better than the standard treatment. This can include new devices, drugs, and vaccines, as well as different combinations of treatment
• Supportive Care/Quality of Life – These studies explore ways to improve the comfort and quality of life of patients. These trials also study ways to better combat the side effects of some treatments
• Genetics Studies – These are generally done with another clinical trial and focus on how genetic makeup can affect detection, diagnosis, or response to treatment

Each clinical trial calls for certain criteria that a patient must meet to be included in that trial. Your age, gender, medical history, current health, and disease state all factor into eligibility. It’s important to remember that clinical trials are completely voluntary. Patients can leave a trial at any time.

Informed consent is the process by which you agree to take part in a clinical trial after receiving information about the purpose of the study, the treatment that will be given, the tests that will be taken, and the risks and benefits of treatment. You must sign a written consent form before being enrolled in a clinical trial. This form says that you understand the study and agree to take part.

Although there are risks with any treatment, there are also many benefits of taking part in a clinical trial.

For example:

• Access to promising new treatments that are not available outside of clinical trials
• The treatment being studied may be better than the standard approach
• Results from the study may help others in the future
• Your care is followed very closely by a research team
• You may be the first to benefit from the new method

Before taking part in a clinical trial, talk to your doctor about some of the risks involved with your treatment.

For example:

• Health insurance may not cover all your costs
• If you are in a randomized trial, you will not be able to choose if you are getting the new treatment or the standard approach
• New drugs or treatments may not be any better than the standard care
• New treatments may have side effects that are not expected
• You may be required to make more frequent visits to the doctor

Before joining a clinical trial, you may want to ask your doctor questions about the study and your treatment.

For example:

• How long will the study last?
• How will I know if the study was successful?
• How will this affect my daily life?
• Who will be in charge of my care during the study?
• What are you trying to learn from the study?
• What are the benefits and risks?
• What are the differences between what is being studied and the standard treatment?
• What do doctors know already about the treatments being studied?
• What treatments and tests will I get during this trial?
• What will I be asked to pay?

If you are interested in joining a clinical trial, talk to your doctor. He or she can help you find out if a trial is right for you.

Before taking part in a clinical trial, it’s important to ask what your costs will be. In some cases, the sponsor of the study (such as the government, drug makers, or technology companies) will provide the new treatment at no cost and pay for any special testing or extra doctor visits. Some sponsors may pay more than this, such as covering travel time and mileage expenses.

However, other trials may pay very little of your treatment costs. If you have private insurance, check with your provider before you begin treatment. It may be willing to pay for some or all of the costs of your treatment, depending on the type of trial. Medicare will pay for the routine costs of some government-sponsored clinical trials. Call your local Medicare provider to find out what Medicare will pay for your treatment.