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 the phases of a clinical trial?
Clinical trials are broken down into phases, with each phase having a different purpose within the trial. Phase I trials involve a small group of people (20-80) and are concerned with determining a safe dose of the drug being studied as well as its potential side effects. In Phase II, the treatment or drug is tested in more people (100-300) for further evaluation - this time, determining the time of the drug or treatment's effectiveness against the disease for which the patient is being treated. Even more people (1,000-3,000) are participants in Phase III of a trial, when the intervention is compared to standard treatments and further information is collected about safety and side effects. In Phase IV trials, conducted after a treatment has been approved for specific indicated conditions by the FDA, post-marketing studies are carried out to collect more information about the optimal use of the drug or treatment and to further evaluate its side effects.
Clinical trials may be carried out in different locations, including hospitals, clinics, individual physician practices, university health centers, or community health centers.
How can one find out what clinical trials are currently being conducted?
The web site http://clinicaltrials.gov is a searchable database of federally and privately funded clinical trials being conducted in the U.S. and around the world. Your doctor or health-care team may also offer information about clinical trials that are currently under way for your specific condition.
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