Clinical Research and Clinical Trials
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.
- 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?
Clinical research and clinical trials facts
- "Clinical" as a term refers to the medical care of real patients.
- Clinical trials are a form of medical research that follow a defined protocol that has been carefully developed to answer a specific patient care question.
- Clinical trials are in use to test cancer therapies, treatments for cardiovascular disease, the safety and efficacy of new drugs, and a number of other conditions.
- Clinical trials may investigate the effectiveness of new drug treatments, new combinations of drugs, surgical procedures, or behavioral and lifestyle modifications.
- Clinical trials are broken down into phases, with each phase having a different purpose within the trial.
- An Institutional Review Board (IRB) consisting of physicians, statisticians, researchers, patient advocates, and others must preapprove every clinical trial in the U.S. This ensures that the trial is ethical and protects patients' rights, and is appropriate to answer the question asked from a scientific and statistical viewpoint.
- Every clinical trial follows a protocol that describes what types of people may participate in the trial; outlines the exact schedule of tests, procedures, medications, and/or dosages involved in the trial; and specifies the length of the study.
- Each trial has specific inclusion and exclusion criteria to determine the exact patient populations that may participate. Inclusion criteria may be based on age, gender, underlying disease, health history, or other factors.
- Double-blinded trials offer the advantage of allowing the treating health-care team and the patient to make unbiased observations about patient progress and the effectiveness of the treatment being evaluated.
- Clinical trials may be sponsored and funded by government agencies, institutions, hospitals, physicians, pharmaceutical or biotechnology companies, advocacy groups, or other organizations.
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