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What is a Clinical Study? Part 1

A clinical study, or trial, is a scientific study that can involve people. You may hear that a new study was published. You may hear that a product was shown to help patients based on clinical research.

What does this mean?

In this article, we will look at clinical studies and what they mean to patients. In future issues, we will look at how clinical research can lead to more options for patients with heart disease. We will also talk to patients that have been part of a clinical study.

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Why are there clinical studies?

A clinical study tries to answer a question about a certain disease or health issue. Each study tries to find better ways to prevent, diagnosis, or provide treatment. Many treatments used today are the result of past clinical research.

At one time, most heart patients were treated with only medicine. Today, clinical studies have made ICDs a big part of treating patients with certain heart problems. For example, the MADIT II clinical study asked if patients who have had a heart attack live longer with heart medications alone or with heart medications and an implanted cardioverter defibrillator (ICD). The study showed that some heart patients could be helped even more when an ICD is part of their therapy.

What happens in a clinical trial?

Patients in a clinical study work with a research team at a local clinic or hospital. The team members may include doctors, nurses, and other health care providers. They will provide the patient (participant) medical care, monitor the patient’s health carefully, and give specific instructions about what the patient should/should not do in the study.

In the United States, the federal government and a hospital’s ethical review board watch clinical studies to make sure that patients are treated as safely as possible.

As the clinical study moves forward, information about the study is presented at scientific meetings and in medical journals. Information is also sent to government agencies, such as the Food and Drug Administration (FDA).

Who can join a clinical study?

The approved study document, or protocol, lists the types of patients that quality to be in the study. The following requirements are common when a clinical study looks at implanted cardiac device therapy. The patient must:

have a certain heart condition, such as coronary artery disease
have symptoms from a disease like heart failure
be on certain medications

Your health care provider may invite you to join a clinical study. This is an important personal decision. It is often helpful to talk to a health care provider, family members, or friends about joining a study.

Controlled clinical studies is one way to find new, safe, and effective treatments for disease. Patients in a study take an active part in their own care. Many patients benefit from access to new treatments for their disease. Patients also receive expert care from the medical experts and health care facilities during the study.

For more information on clinical studies, go to www.clinicaltrials.gov

Figure 1. Boston Scientific Implantable Device

Talk to your doctor about important safety information.