Clinical Research

What is a Clinical Trial?

Clinical researchers test the safety and effectiveness of new medications and treatments for cardiovascular disease. This testing, called a clinical trial, may focus on a new medication, compare a new medication to an existing medication, or evaluate whether an existing medication is effective for a new use.

A clinical trial consists of four phases. The medication must successfully pass each phase and receive Food and Drug Administration approval before moving on to the next phase:

• Phase 1: During phase 1, the safety and dosage are tested in 20-100 volunteers. An estimated 70% of experimental drugs are approved to move on to phase 2.
• Phase 2: Phase 2 testing focuses on the drug’s effectiveness and potential side effects. This phase can last up to two years and involves up to several hundred volunteers. About one-third of experimental drugs pass this stage and get approval to move on to phase 3.
• Phase 3: Phase 3 is large-scale testing of safety and effectiveness using several hundred to several thousand participants. About 70%-90% of all drugs are approved to be placed on the market.
• Phase 4: After a drug goes on the market, the clinical trial continues to monitor for safety and side effects. If any concerns are discovered, the FDA pulls it off the market or restricts its use.

How Can I Benefit From Participating in a Clinical Trial?

The most pressing reason to participate in a clinical trial is that it gives you access to new medications before they’re available to consumers. Many patients have gone through all the standard treatments without success and need new options. Others volunteer for the opportunity to advance medical science.

During a clinical trial, you also have access to expert medical care. The cost of your appointments and treatment is usually covered. Some clinical trials may also offer compensation for your time and travel.

What Types of Clinical Trials are Open for Volunteers?

New clinical trials are constantly being developed and conducted at Phoenix Heart. As one study ends, they need volunteers to start the next one.

These are a few examples of clinical trials conducted at Phoenix Heart:

• Congestive heart failure: screening for cognitive changes in patients taking medications to treat congestive heart failure
• Heart attack: evaluating a medication’s ability to prevent a future heart attack in patients who recently suffered a heart attack
• Atrial fibrillation: testing a medication’s ability to prevent blood clots in patients with a pacemaker for atrial fibrillation

To learn about our current clinical trials, call Phoenix Heart or ask your doctor at your next appointment.