Types of Clinical Trials
There are local (institution-specific) research studies and multicenter clinical trials where the same clinical trial is being conducted at more than one medical center or clinic in the U.S. or globally. St. Vincent is often recruited as a multicenter trial site because of our high level of heart care and for the highly regarded expertise of our cardiovascular physicians.
A clinical trial typically falls into one of two categories:
Observational Studies
Observational Studies: The purpose of an observational study is to collect patient-specific information (such as gender, race, height, weight and routine blood test results) during a period of time to see how these variables affect a disease.
For example, researchers have learned from several heart failure registries that patients with kidney disease are at higher risk for readmission to the hospital after an initial hospitalization for heart failure. Many of these heart failure observational studies report that the incidence of heart failure in the United States and around the world increases sharply with age, and that hypertension is an important risk factor for the development of heart failure later in life.
Therapeutic Trials
Therapeutic Trials: Non-medical, medication or surgical device interventions are studied in a therapeutic trial to see the effect of an intervention on a specific medical condition. Non-medical interventions refer to dietary changes (such as a low vs. high salt diet) or exercise. Therapeutic trials often include patient education sessions to help these individuals better understand their medical condition.
This type of clinical trial is organized with a control group (a group that receives standard therapy but not the new treatment being tested) and a treatment group (the group receiving the new treatment, either in addition to standard therapy or compared directly to standard treatment).
Participating in a randomized trial means the participant is randomly placed in either the control group or the treatment group to ensure a fair comparison. The control group is an important part of the trial.
For example, in a medication therapy trial, the control participants receive the standard treatment and a (sugar) pill (a placebo) with inactive ingredients that look similar to the new medication therapy being tested. Most randomized trials are double-blind, which means the physician-investigator does not know if the patient is in the control or treatment group. A study that is randomized and double-blind removes possible bias on the part of the physician because all patients get the same clinical experience.
The Food and Drug Administration (FDA) usually requires a randomized and double-blind trial with vigorous testing before a new drug or medical device can be approved and used.
In an open label trial the subjects all receive a specific therapy that is being studied. The purpose of an open label trial is to study the safety of a given treatment or intervention. The results from open label participants are compared to historical controls available from other trials or observational studies. Open label trials have limitations, and for this reason St. Vincent cardiovascular researchers and coordinators work very hard to match appropriate patients to these trials for the benefit of enhanced patient safety and outcomes.
A diagnostic trial refers to a study that is evaluating better tests or procedures for diagnosing a particular disease or condition. In these studies, often a radiologist, interventional cardiologist, geneticist and/or pathologist is involved in the study protocol.
A screening trial refers to a study that evaluates the best way to increase early detection of cardiovascular diseases or health conditions with screening tests.