How are Clinical Trials conducted?
Each trial is conducted under a protocol, a guide that spells out what is to be done, how it is to be done, and why. Protocols incorporate ways to answer research questions and to safeguard the medical and mental health of patients. Some trials test just one treatment in a group of patients. More typically, a trial will include two or more groups who are as similar as possible, each of which receives a different treatment option: the treatment of interest, a standard treatment for the disease (an active control), an inactive substance (a placebo control), or no treatment at all. All of the groups are then monitored in exactly the same way. Several things (besides the treatment) can influence (or bias) the results of the study. For example, if the groups being studied are very dissimilar to begin with, any differences between them at the end of the study may simply be an extension of these baseline imbalances. If the groups are as similar as possible to each other before treatment, it i
The doctors who conduct a clinical trial follow a carefully designed treatment plan called a “protocol.” This spells out exactly what will be done and why. Studies are planned to safeguard the medical and psychological health of patients as well as to answer research questions. Some clinical trials test one research treatment in one group of patients. Other trials compare two or more treatments in separate groups of patients who are similar in certain ways, such as the extent of their disease. This way, the treatment groups are alike and the results from each can validly be compared. One of the groups may receive standard (the most accepted) treatment so the new treatments can be directly compared to it. The group receiving the standard treatment is called the “control” group. For example, one group of patients (the control group) may receive the usual surgical treatment tor a certain cancer, while another patient group with the same type of cancer may receive surgery plus radiation th
The doctors who conduct a clinical trial follow a carefully designed treatment plan called a protocol. This spells out what will be done and why. Studies are planned to safeguard the medical and psychological health of patients as well as to answer research questions. Some clinical trials test one research treatment in one group of patients. Other trials compare two or more treatments in separate groups of patients who are similar in certain ways, such as the extent of their disease. This way, the treatment groups are alike and the results from each can validly be compared. One of the groups may receive standard (the most accepted) treatment so the new treatments can be directly compared to it. The group receiving the standard treatment is called the control group. For example, one group of patients (the control group) may receive the usual surgical treatment for a certain cancer, while another patient group with the same type of cancer may receive surgery plus radiation therapy to see
The doctors who conduct a clinical trial follow a carefully designed treatment plan called a “protocol.” This spells out what will be done and why. Studies are planned to safeguard the medical and psychological health of patients as well as to answer research questions. Some clinical trials test one research treatment in one group of patients. Other trials compare two or more treatments in separate groups of patients who are similar in certain ways, such as the extent of their disease. This way, the treatment groups are alike and the results from each can validly be compared. One of the ways to prevent the bias of a patient or doctor from influencing study results is “randomization.” If a patient agrees to be randomized, this means he or she is selected by chance to be in one group or another. The researchers do not know which treatment is best. From what is known at the time, any one of the treatments chosen could be of equal benefit to the patient. If a treatment in a trial is not he
The doctors and researchers running a clinical trial develop a written plan detailing exactly how the trial will be conducted. This plan, also called a protocol, explains how the trial will be run, what information will be gathered, and what new things the researchers hope to learn. Many clinical trials compare a new treatment to a standard treatment. In these trials, participants are divided into two groups. One group receives the new treatment and one group (the “control” group) receives the standard treatment. Various statistics are then gathered using blood, x-ray, and other tests to assess how well each group responds to the two kinds of treatment. In order to prevent biased results or interpretation, many trials assign participants by chance to one of these two groups. This process, known as randomization, is only used when it is not known which treatment option will work better.
