All of our clinical trials are conducted according to strict scientific and ethical principles. Each trial is carefully designed to show how a particular anti-cancer treatment will affect the people who choose to participate. Before they are allowed to begin, all trials are closely reviewed by independent investigators, who ensure that the trials are scientifically sound and that they protect the safety of those who participate. Such reviews are required for all trials whether they are funded by the government, the institution or a pharmaceutical company. University of Chicago Medicine Comprehensive Cancer Center clinical trials are carefully examined by members of its Institutional Review Board (IRB), which focuses on patient safety, and our Protocol Review and Monitoring System (PRMS), which focuses on the science by asking, for example, whether the study is designed well and if the results will tell us something important. Either the IRB or PRMS can stop a trial early if it is determined that a new treatment is not effective or if significant safety concerns arise.
Several federal government agencies also help ensure that all research is conducted with patient safety in mind. The Office of Human Research Protections (OHRP) is the government’s main guardian of patient safety and welfare in clinical trials. It enforces the rules regarding the informed consent process (see below), institutional review boards (IRBs), and the participation of people with special needs in clinical trials, such as children and those with mental disabilities. The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), sponsors many of the cancer clinical trials going on at any one time and conducts its own review of these studies before they are approved. The final authority on clinical trials is the Food and Drug Administration (FDA). The FDA reviews clinical trial information and decides whether the results of a study are safe and effective enough to be approved as a standard treatment.
Each person who enrolls in a clinical trial is informed about all aspects of a study’s treatments and tests, including why each portion of the study is necessary, as well as its possible benefits and risks, prior to deciding to participate. The principal investigator (PI) of a study is required to obtain the informed consent (generally written) from all clinical trial participants prior to the start of the trial. During the informed consent process, the researchers (doctors or nurses) will explain the details of the study to participants and respond to any questions and concerns.