Before Clinical Trials
For many years, medical advances were made merely by physician investigators reporting their experience with different therapies. This was reasonably successful when scientific methodology was difficult to apply because medical sciences theories about the true mechanisms of disease were unavailable.
How Clinical Trials are Administered
Most therapies have the proven efficacies they need to be studied in well-designed clinical trials. These trials usually involve comparing a new medicine or procedure to existing therapy. It is typical for an inactive pill, or placebo, to be given to some of the patients in a clinical trial. This is necessary because many patients benefit psychologically from any medicine and are likely to have improved clinical result, which may mask the true benefit, or harm the new medicine being studied. This has been shown in numerous cardiology studies over the last 10+ years when a variety of heart medicines to treat congestive heart failure and heart rhythm irregularities were shown to be harmful. In these trials, patients receiving the placebo fared better than those receiving the investigational medicines. Because of these observations, the Food and Drug Administration, prior to approving new medicines for use in the general medical community, typically requires trials where a new medicine is compared to a placebo.
Testing New Medications
These are the only ways to truly test the efficacy and safety of new medications. For example, many trials show that patients in the placebo group will often have side effects equal to those receiving the active medication. This is particularly common for side effects such as insomnia, headache, mild gastrointestinal upset, etc.
Patients Benefit from Studies
Patients with serious diseases almost always benefit from participating in these well-designed clinical trials for numerous reasons. In general, if the patient participates in the trial, it is because he/she has a condition for which better therapies are needed and conventional therapies are not totally satisfactory. Generally, physicians participating in these trials have extensive knowledge about the specific disease in these trials. Patients in these trials are carefully followed by the clinical team of the research center and receive extra care and lab work, which will enhance their care during the conduct of a trial. Many studies have shown that patients receiving even the placebo in the clinical trial fair better than their counterparts receiving standard care within the community.
Stern Cardiovascular's Focus
Our clinical trials have focused on several areas within cardiovascular disease. Our largest experience in treating patients with heart muscle weakness often manifests as congestive heart failure. Many patients with this disease will have a mortality rate each year of more than 10% when receiving conventional therapy. We have ongoing trials looking at new medications which are added to conventional therapy in hopes of reducing complications due to progressive heart muscle weakness, cardiac rhythm irregularities, and other consequences of congestive heart failure. These involve medications that block excessive spasm of the arteries within the body, block excessive inflammatory response, and drugs and implantable devices that block catastrophic unpredictable heart rhythm irregularities.
Heart muscle weakness is such a serious disease that most patients will benefit from being in these clinical trials. Another area of research involves patients with heart attacks treated with emergency use of balloons (angioplasty or intravenously administered enzymes known as clot busters. Although these are relatively successful state-of-the-art therapies, they still leave some patients with extensive heart muscle damage. We are investigating the use of several additional treatments such as hormonal infusions during the acute phase of heart attacks as well as antibodies which block and excessive white blood cell inflammation of the area of heart attack.