Cancer Clinical Trials
The Kraemer Cancer Center stays on the forefront of the search for new medications and treatments, offering patients the opportunity to participate in clinical trials for new drugs, therapies, technologies and surgical procedures. Because the Kraemer Cancer Center is part of the Froedtert & the Medical College of Wisconsin Cancer Network, eligible patients also have access to select clinical trials conducted through Froedtert & the Medical College of Wisconsin. Patients can feel confident they are receiving the highest quality and standard of cancer treatment.
Clinical Trials Help Test New Treatments
In cancer research, a clinical trial is a study conducted with cancer patients, usually to evaluate a new treatment or new combination of treatments. Each study is designed to answer scientific questions and to find new and better ways to help cancer patients.
Before a new treatment is tried with patients, it is carefully studied in the laboratory. But this early research cannot tell us exactly how a new treatment will work with people. Clinical trials help us find out if a promising new treatment is safe and effective for people. In this way, new treatments, which are often based upon the current standard, become the new standard.
Clinical Trial Types
Although there are many kinds of clinical trials, which range from studies of ways to prevent, detect and diagnose cancer — to studies of quality of life, most of the studies we offer through the Cancer Network deal with new ways to learn about and treat the disease. These studies will include any combination of the following: surgery, radiation, chemotherapy and biologic therapy. Biologic therapies are recently discovered treatments that affect the immune system.
Clinical trials are carried out in phases, each phase designed to find out certain information. Thus, Phase I trials are designed to determine appropriate dosage and anticipated side effects. Phase II trials are designed to determine the actual effect of the treatment on a specific kind of cancer. If the treatment shows anti-tumor activity in a Phase II trial, it may then enter a Phase III trial where it is compared to the standard treatment for a specific cancer. Phase III trials are randomized by a national office and the participating patient or doctor cannot choose which type of treatment the patient will be given.
Being in a Clinical Trial
Initially, it needs to be determined if you are eligible on the basis of the type and location of your cancer, as well as your general health. Your doctor will determine this with a thorough evaluation. You must remember, also, that as a patient participating in a clinical trial, you have a role in the successful completion of the trial. In any case, once you have been determined eligible, the decision is yours.
Patients in a clinical trial receive their care in the same place that standard treatments are given — at cancer centers, hospitals, clinics or doctors' offices.
If you join a research study, you will be watched closely and data on your case will be carefully recorded with the assistance of a clinical research coordinator. This data is sent to the office which coordinates the study. During the course of a study, if it is clear that a treatment is not in your best interest, you will be removed from the study and other options will be discussed with your doctor.
Your Protection in Clinical Trial Participation
The ethical and legal codes that govern medical practice apply to clinical trials. Most clinical research is federally regulated, with built-in safeguards to protect patients. All of the clinical trials offered through the Cancer Network have been reviewed and approved by an Investigational Review Board (IRB). IRBs consist of clinical and non-clinical members, and follow federal guidelines developed by the Office for Human Research Protections (OHRP).
Informed consent is a process by which the participating patient receives written information regarding the study, discusses the trial with his or her doctor, nurse and data manager, as well as with significant others, and after learning about the benefits and risks, agrees to participate by written signature. However, anytime the patient chooses not to participate, the decision is acceptable and does not affect the ability to receive high quality care in our facility.
Importance of Clinical Trials
Through clinical trials, doctors and researchers learn which approaches are more effective than others. New cancer treatments must prove to be safe and effective and scientifically designed; clinical trials are the best way to achieve this objective. Many standard treatments now commonly used were first shown to be effective in clinical trials.
More Information on Clinical Trials
If you have additional questions about clinical cancer research, please ask your doctor or nurse. Or, you can visit several websites that can provide a wealth of information about clinical trials: