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| What is Research |
Research is a study done to answer a question. Scientists do research because they don't know for sure what works best to help you. Research leads to important discoveries that make our lives better. Some examples are: A clinical trial is a research study conducted under the supervision of a qualified physician and other research professionals. Clinical trials are designed to collect data, evaluate aspects of medical devices or investigational medical products such as effective dosage and safety. Each trial has its own rules or protocols and these vary from trial to trial. Institutional Review Board is an independent external review body whose purpose is to insure subject safety and protect patient rights. Names of review boards used by clinical research facilities include: Sterling IRB, Great Lakes IRB, Western IRB, Copernicus IRB. A Phase I clinical trial assess the safety of a drug or device. This is the first phase of testing in healthy human individuals after animal studies have been completed. This phase involves a small number of healthy volunteers (200-100) to particpated and can take several months to complete. Studies in this phase are designed to determine the effects of drugs or devices on humans. This phase looks at dosage levels, absorption, metabolism, excretion and side effects. A Phase II Clinical trial assess the safety of a drug or device. This is the first phase of testing in healthy human individuals after animal studies have been completed. This phase involves a small number of healthy volunteers (20-100) to participate and can take several months to complete. Studies in this phase are designed to determine the effects of drugs or devices on humans. This phase looks at dosage levels, absorption, metabolism, excretion and side effects. A Phase III Clinical Trial is usually randomized and blinded and involves several hundred to several thousand volunteers. The study can take several years to complete. These studies offer the most comprehensive data on the range of side effects, benefits, and effectiveness of a drug or device. A company can request FDA approval to market a drug when phase III testing has been completed. Phase IV clinical trials are also known as Post Marketing Surveillance trials. These trials are conducted after a drug or device has been approved by the FDA. It is possible for an approved drug to be taken off the marked or restricted depending on results of phase IV trials. Cells in the human body contain a type of molecule called deoxyribonucleic acid, or DNA for short. DNA determines the makup of the genes. Genes are inherited and direct growth, development, and determines how the body functions. For example, some genes control the color of the hair or eyes. Scientists have learned a lot about how genes work. There are many differences, or variations, in DNA from one person to another. These variations may affect a person's chances of suffering from a particular disease or the way a person responds to a particular drug. You/your child may be asked to provide a blood sample for genetic research that will determine a part of the structure of you/ your child's DNA and will enable us to compare it to medical information about you/your child. Be sure to ask the Study Coordinator if you have any questions or concerns regarding this Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics. An ethics committee must review clinical research studies before they begin. In addition, the FDA (Food and Drug Administration), a department of the U. S. government, sets requirements for drug testing. The ethics committee reviews the results from certain clinical research studies to decide if an investigational drug should be made available to the general public. |
| © 2009 Allergy & Asthma Center, PA |