Clinical Trials (cont.)
Melissa Conrad Stöppler, MD
Melissa Conrad Stöppler, MD, is a U.S. board-certified Anatomic Pathologist with subspecialty training in the fields of Experimental and Molecular Pathology. Dr. Stöppler's educational background includes a BA with Highest Distinction from the University of Virginia and an MD from the University of North Carolina. She completed residency training in Anatomic Pathology at Georgetown University followed by subspecialty fellowship training in molecular diagnostics and experimental pathology.
William C. Shiel Jr., MD, FACP, FACR
Dr. Shiel received a Bachelor of Science degree with honors from the University of Notre Dame. There he was involved in research in radiation biology and received the Huisking Scholarship. After graduating from St. Louis University School of Medicine, he completed his Internal Medicine residency and Rheumatology fellowship at the University of California, Irvine. He is board-certified in Internal Medicine and Rheumatology.
In this Article
- Clinical research and clinical trials facts
- What is clinical research?
- Why is clinical research important?
- What are clinical trials?
- What are the phases of a clinical trial?
- How can one find out what clinical trials are currently being conducted?
- How is a clinical trial performed, and what sort of preparation is needed?
- What is informed consent?
- Is patient privacy maintained in a clinical trial?
- Who can participate in a clinical trial?
- Are people paid for participating in clinical trials?
- What are the pros and cons of participating in a clinical trial?
- Can a person leave a clinical trial once it has started?
- Who sponsors clinical trials?
- What happens after a clinical trial is completed? Is there follow-up care?
What are clinical trials?
Clinical trials are a form of clinical research that follow a defined protocol that has been carefully developed to evaluate a clinical question. The U.S. National Institutes of Health (NIH) defines a clinical trial as
- "a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (such as drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)."
Although people commonly associate clinical trials with drug trials, in which new medications or combinations of drugs are tested for their effectiveness against a disease, clinical trials may also evaluate whether interventions such as counseling or lifestyle modifications have an effect on disease progression. Clinical trials may be conducted on people who have a disease or on healthy people, depending upon the purpose of the research.
The U.S. NIH describes the following types of clinical trials:
- Treatment trials test new treatments, new combinations of drugs, or new techniques in surgery or radiation therapy.
- Prevention trials are designed to identify ways to prevent disease through the use of medicines, lifestyle changes, dietary supplements such as vitamins, or immunizations.
- Diagnostic trials aim to identify improvements in tests or methods used to diagnose disease.
- Screening trials look for ways to detect specific conditions.
- Quality of life trials (also referred to as supportive-care trials) are trials that are designed to improve comfort and the quality of life for people suffering from chronic conditions or diseases.
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