7 “Randomly” means that you have an equal chance of being assigned to either of the groups. By doing it this way, the study avoids being affected by human decisions about who gets assigned to which group. In addition, many trials are double-blinded. That means that neither your doctor nor you will know what group you are assigned to. However, in the event of an emergency related to your health and safety, the treatment you are taking will be made available to your care providers. What if no standard treatment is available to compare to the new treatment? If there is no standard treatment, in some cases a placebo may be used as the comparator. A placebo is a pill that looks like the pill received by the treatment group, but contains no active medication. In a clinical trial with one treatment group and one control group, you could have a 50% chance of being in the control group and receiving the inactive pill (placebo). You should ask your doctor what your chances of receiving the study treatment are if you decide to participate in the clinical trial. All participants in a clinical trial must be told in advance whether a placebo will be used in the study. What happens if the new treatment appears to be harming me? In a clinical trial, your doctor will be closely monitoring you for any signs of harm and will stop the treatment if any signs of harm appear. Additionally, your doctor will be made aware to discontinue the study if a signal of harm is detected in other study participants or if more data (information) from the study is no longer needed, such as if the study is stopped early because overwhelming benefit is seen or if the study is halted because no benefit is seen. Your doctor is obligated to stop any treatment that appears to be harming you. You also have the right to stop your participation in any clinical trial, for any reason, at any time. If you decide to stop participating in a clinical trial, you should talk with your doctor about your decision and the treatment options available to you. Remember, you must never stop a treatment without your doctor’s guidance. Many study treatments must be switched back to standard therapy or weaned off to maintain the level of health you had before entering the study. If you decide to stop participating in a clinical trial, you may be asked if you are willing to allow the information collected from you in the study so far to be used. The decision to allow use of information collected from you during the study is entirely up to you. You should discuss stopping your participation with your doctor before discontinuing treatment, since stopping a treatment abruptly can have serious side effects.
P1072a ABC Clinical Trials GTG
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