|
Why are Clinical Trials needed?
The Medical world cares about human conditions. That's why researchers are constantly looking for new or better ways of treating illness and disease. Their discoveries cannot be put into general use until the Food and Drug Administration (FDA) Controlled Testing has been done in clinical trials.
Clinical trials are the only way testing can be done. The FDA requires carefully controlled clinical trials before it will approve a new treatment as safe and effective for public use. Clinical trials are the link between research and the relief of human suffering.
Clinical trials for the advancement of cardiovascular studies are available through the Sacramento Heart and Vascular Research Center. We conduct pharmaceutical-sponsored trials to support and enhance research in our community.
What is a Clinical Trial?
Advances in medicine are the result of ideas leading to new medical therapies. A clinical trial is a carefully designed study carried out with people like you who volunteer to receive investigational treatment under close supervision by a physician and other research professionals.
Pharmaceutical and biotechnology companies have developed these treatments. These companies have selected physicians (also referred to as "investigators") who are qualified to conduct clinical trials. It is through these trials that investigational drugs and treatments may show their benefits. A clinical trial is a partnership and a commitment between doctors and volunteer patients. It is the final test in a series of many that are done to improve the quality of life.
The clinical testing of an investigational drug is a step-by-step process that ensures volunteer patients receive careful medical attention. The U.S. government's Food and Drug Administration (FDA) review all clinical trials.
How are experimental drugs tested in humans?
Clinical testing of experimental drugs is normally done in three phases. Once the Food and Drug Administration (FDA) has granted a New Drug Approval (NDA), pharmaceutical companies also conduct post marketing or late phase four studies.
Phase One Study: These studies are primarily concerned with the drug's safety. Testing is done on healthy volunteers and the study is designed to determine what happens to the drug in the human body.
Phase Two Study: Once the drug has been shown to be safe, it must be tested for efficiency.
Phase Three Study: These studies are done on a large scale to provide the pharmaceutical company and the FDA with a more thorough understanding of the drug's effectiveness, benefits and the range of possible adverse reactions. Most phase III studies are randomized with one group receiving the experimental drug while the other receives a placebo. Often these studies are also "blinded" — neither the patient nor the researchers know who is getting the experimental drug.
Phase Four Study: Pharmaceutical companies usually conduct phase four studies to compare a drug with other drugs already in the market or determine long-term effectiveness and impact on a patient's quality of life.
Why are Clinical Trials important?
Through clinical trials researchers lean which approaches are more effective than others. Each study is designed to answer specific questions and to find new ways to help patients. Most standard treatments used today were originally shown to be effective through clinical trials.
Why should I participate in a Clinical trial?
As a volunteer in a clinical trial, you help in the development of medical therapies that may offer better medical treatments and cures.
People volunteer for a number of reasons. You may want to become involved simply because you want to help in the advancement of science. You may have been diagnosed with a disease for which a satisfactory treatment does not presently exist. You may even join a clinical study or trial for improved medical care.
Whichever reason you choose, you may have questions about clinical research. Prior to volunteering for a clinical trial, your physician and your research center's staff will be pleased to answer questions you may have.
If I participate in a Clinical Trial what can I expect?
Participating in a clinical trial is much like a regular visit to a medial clinic or doctor's office, but with greater personal attention. The success of any trial depends on its volunteers. Patients are treated professionally and with careful monitoring.
A detailed description of your specific clinical trial and what is expected of you will be outlined within your consent form. Once you have enrolled in a study, your medical history will be reviewed. You may receive a physical examination, lab work, or other tests that the study requires at no cost.
No fee
Study-related exams and medications are provided at no cost to qualified participants.
What are the risks?
Patients should decide if they want to take part in a clinical trial only after they understand both the possible risks and benefits
Risks vary from trial to trial. Unfortunately, no one can say with certainty what the risks of a particular trial might be. Although researchers expect certain results from each trial, the fact that a treatment is still being studied makes it impossible to rule out side effects or complications.
Need transportation to and from the Center?
Sacramento Heart & Vascular Research Center offers van services to our research patients who live out of the area or who have difficulty finding transportation at no cost.
| 
