Clinical Trials

• What are the potential benefits and risks of participating in a clinical trial?

  Each clinical trial offers potential benefits, and it can include certain potential risks. Clinical trials have some things in common, though. For the most part, clinical trial benefits include access to new drugs and treatments before they are widely available, close monitoring of your healthcare and any side effects, the chance for you to play a more proactive role in your own healthcare, and the opportunity to make a valuable contribution to cancer research. Potential risks may include the possibility that the new drugs and procedures have side effects that are not known to clinicians and/or that the new treatments are less effective than current approaches.



• How are participants protected?

  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.



• Who is eligible to participate in a clinical trial?
  
  Each study has its own guidelines outlining who is eligible to participate. Participants are typically chosen because they share common conditions, such as the type and stage of cancer, age, or gender. Our clinical trials are designed to benefit a broad scope of participants, with a variety of different types of cancer and having received a variety of past treatments.


• What happens before a clinical trial begins?
  
  Clinical trials are initiated only after a number of “pre-clinical” studies are performed and found to suggest that a proposed treatment is likely to be safe and effective. Pre-clinical studies include experiments performed on cancer cells grown in a laboratory and in laboratory animals. Although pre-clinical studies provide a lot of useful information, they do not give all the answers. For example, humans and animals may have different reactions to the way a new drug is absorbed and processed. A treatment that works against cancer in a mouse, for instance, may not work in people. If pre-clinical studies are completed and the treatment seems promising, the FDA must give permission to test the new treatment in humans.


• How can I find out if there is a clinical trial that is right for me?
  
  Since each clinical trial has different enrollment criteria, we recommend that you and your physician look over the available clinical trials and contact the PI for further information. Your physician and PI will be able to help you identify if a trial is suitable for you, help explain the trial, and answer any other questions you may have.

Additional Resources

• National Cancer Institute
• American Cancer Society