The physicians and research nurses who conduct a clinical trial follow a carefully designed treatment plan called a “protocol.” This plan 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 on 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 treatment for a certain illness, while another patient group with the same type of illness may receive a new treatment to see if this improves the rate of recovery from the illness. Sometimes, no standard treatment yet exists for certain illnesses. In drug studies for such cases, one group of patients might receive a new drug and the control group without treatment if there is any known treatment that would benefit that patient. In each of these types of
studies, the control group is followed just as often and carefully as the “treatment” group. One of the ways to prevent the bias of a patient or physician from influencing study results is “randomization.” If a patient agrees to be randomized, this means he of 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. If the treatment in a trial is not helping the patient, the patient's physician can decide to take him or her out of the study. Of course, the patient can decide to leave, as well, and still receive other available care from their physician. There are regular reviews of the results of a trial and the information is shared. If a treatment is found to be too harmful or not effective, it is stopped. Also, when there is firm evidence that one method is better than the others in a study, the trial is stopped and all patients in the trial are given the benefit of the new information. Such information may help present and future patients. Throughout a any clinical study, a patient's personal physician will be kept well informed of the patient's progress. As in any study, patients are also encouraged to maintain frequent contact with their referring physician. |
