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P1072a ABC Clinical Trials GTG

6 The medical researchers submit the data to the FDA and it is reviewed to ensure that the treatment is safe and effective. Only then is that new treatment offered to the general population, either over the counter or by prescription. What else should I know about how clinical trials work? Clinical research professionals monitor the treatment provided by your doctor to make sure your doctor does exactly what the protocol states. Keep in mind that the study protocol may not allow your doctor to make substitutions in your treatment while you are participating in the clinical trial. Clinical trials are closely monitored and tightly controlled for your protection. How are clinical trials conducted? Clinical trials are conducted in phases. First, the research starts with a small group of people who may be healthy volunteers. If no major problems are seen, it is offered to a larger number of people, including those who have the illness to be treated. After the FDA approves the new treatment, it becomes available to even more people. Oftentimes studies are performed on the treatment even after the treatment has been released to the public. These studies are necessary to ensure the drug or device is safe and effective in a broader range of people in a real-world setting or to determine if the treatment could possibly have additional benefits. So, a good clinical trial program starts small and then expands. What can I expect from participating in a clinical trial? If you participate in a clinical trial, you will follow a specific treatment plan that your study doctor will give you. Your study doctor may be different from your primary care practitioner but they should communicate with each other throughout your participation in the study. There may be certain tests you must take to qualify to participate in a clinical trial. The screening tests are performed to exclude those who may not benefit or could possibly be harmed by the study treatment. The treatment plan is based on the protocol for the particular clinical trial. Depending on the study protocol, you may be randomly assigned, like flipping a coin, to either a group taking the new treatment (called the treatment group) or a group taking the standard treatment (the control group).


P1072a ABC Clinical Trials GTG
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