What is a clinical trial?

April 14, 2011 By Bethany Carr, R.N., B.S.N.

When you read a newspaper, you may see advertisements seeking participants for a clinical trial. You may have even seen such a notice on a billboard or heard about a clinical trial on the radio. It's not uncommon for a hospital or physician to be conducting one or more trials aimed at evaluating a new treatment or comparing a new treatment to what's currently accepted as best treatment for a disease or condition.

A trial can look to discover a new drug's side effects as well as its effect on a certain disease or condition. Once a drug is proven to work, another study compares the drug with current treatment to find what drugs work best and have the fewest side effects. Typically, a trial has four phases. Trials at The Hospital of Central Connecticut (HCC), for example, are most often phases II and III. These evaluate a drug's safety and if the drug performs as intended for a specific disease. Trials most commonly conducted at HCC are those related to cancer, diabetes, endocrinology and psychiatry.

Benefits of participating in a clinical trial include access to a new drug not FDA-approved for a disease under study. Most often, the drug company supplies the drug at no cost to the participant. Being part of a trial provides important data about the drug under study and its effects on the participant. This information helps with the current study and may help lead to better care for future generations that may suffer from this disease.

A patient's safety is paramount during his or her participation in a clinical trial. Before a clinical trial begins at HCC, for example, the study must be approved by the hospital's Institutional Review Board, which carefully evaluates the study's objective, safety and design. HCC clinical trial participants are monitored carefully by their physicians throughout the study and after its completion. To participate in a study at HCC, strict eligibility criteria must be met, and the patient needs to review and agree to a consent. A participant can withdraw from a study if participation is no longer possible, no longer desired or if there is a safety risk; the participant's physician can also withdraw the patient.

If you are interested in a clinical trial, these are some questions you should ask your doctor:

• Am I eligible for a clinical trial?
• What are the trial benefits?
• What are the trial risks?
• What side effects can I expect?

Bethany Carr is a nurse navigator for The Hospital of Central Connecticut's comprehensive breast program. For more information about oncology clinical trials at HCC, click here. To search for a clinical trial, call Angie Yrayta, HCC clinical research coordinator, at 860.224.5900 ext. 6717.