Clinical Trials and Research
A clinical trial is a study of a medical treatment in human subjects. After laboratory research shows that a new method has promise for preventing cancer, treating cancer, or managing the side effects of cancer, it must be tested with humans in a clinical trial to answer questions about safety and effectiveness. There are different types of clinical trials, each with several phases involving a successively greater number of people who have voluntarily chosen to participate.
Phase I: Tests safety, dose, schedule, and method of administration
Phase II: Continues to test safety and begins testing effectiveness on a particular type of cancer.
Phase III: Compares a new drug to the current standard treatment. Safety and effectiveness continue to be measured. The new treatment is thoroughly evaluated before it progresses to the next testing phase. The FDA uses this information when they consider approving the drug for general use.
Types of Clinical Trials
Treatment Trials: Test new treatments (drugs, surgery, and radiation therapy), new combinations of treatment, and new methods (gene therapy, vaccines).
Prevention Trials: Test new ways to prevent cancer. May include medicines, vitamins, or diet.
Cancer Control & Previous Trials: Test new ways to control cancer side effects.
Why would a patient be interested in a clinical trial?
Patients take part in clinical trials for many reasons. Usually, patients hope that a new treatment will benefit them directly. They may hope for a cure of their disease, a longer time to live, or a way to feel better. Often they want to contribute to a research effort that may help others.
Regardless of the results, a clinical trial is conducted because the researchers involved in a study have reason to believe that it will be as good as, or better than, current treatments.
At June E. Nylen Cancer Center, patients involved in clinical trials are among the first to receive new research treatments from Siouxland Hematology-Oncology Associates’ special research team. All patients in clinical trials are carefully monitored during the trial and during the follow-up period afterwards. They become part of a network of clinical trials carried out around the country. In this network, doctors and researchers pool their ideas and experience to design, monitor, and evaluate clinical studies.
Facts and Fiction
Choosing to participate in a study gives patients access to treatment and potential benefits from therapy that might be unavailable outside the clinical trial. It also gives these determined volunteers a chance to contribute to the future of others through research.
Many people harbor misconceptions about this component of research, fearing they will receive less than standard quality care, receive a “dummy” placebo treatment, or be treated like a guinea pig. Not true! Placebos are never used in place of a known treatment for cancer. Most studies compare the current “gold standard” of treatment against one that appears to be even more effective, and most patients appreciate the keen health monitoring by physicians conducting the trial.
Both practices housed at the Cancer Center participate in clinical trials. Siouxland Hematology-Oncology Associates (SHOA) has been a research leader for more than 20 years and frequently partners with Siouxland Radiation Oncology in clinical trials. They are currently involved in 140 studies, bringing state-of-the art scientific resources to the Siouxland community. During the past ten years, almost 1,500 Siouxland patients have chosen to enter clinical trials.
A staff of clinical research associates works closely with physicians, nursing and lab personnel to determine patient eligibility, conduct data collection and submission, and interpret the procedures to guide administration of a new treatment. Donald Wender, PhD, MD, is the current Principal Investigator. As such, he actively participates in research group meetings and serves on a national team that audits many of the major research groups in the country.
The three primary groups with which we participate are North Central Cancer Treatment Group (NCCTG) that is based at Mayo Clinic and includes network of more than 1,000 cancer specialists contributing their expertise. The Eastern Cooperative Oncology Group (ECOG) is based at Harvard University. ECOG one of the oldest and largest groups launched to perform cancer clinical trials and partners with more than 6,000 physicians, nurses, pharmacists, statisticians, and clinical research associates. The third group is National Surgical Adjuvant Breast and Bowel Program (NSABP). They were one of the first groups to undertake large-scale studies of breast cancer prevention and were instrumental in bringing Tamoxifin through FDA approval. NSABP continues its pioneering research through affiliation with over 6,000 physicians at 300 sites in the U.S., Canada, and Australia.
National Research Studies The Nylen Cancer Center participates in national research programs in an effort to understand and reduce the incidence of cancer. Involvement in national research studies provides the Nylen Cancer Center’s oncologists with the latest information regarding advances in cancer treatment. Medical oncologists conduct research through the National Cancer Institute. The physicians utilize treatment plans designed by the North Central Cancer Treatment Group, the Eastern Cooperative Oncology Group, and the National Surgical Adjuvant Breast and Bowel Project.
Approximately one out of every three Americans will be diagnosed with cancer during their lifetime. Despite these statistics, cancer treatment is improving survival and quality of life. Every breakthrough in cancer treatment is a result of dedicated physicians, patients, and research staff, and the five-year survival rate has risen steadily since the mid l970’s as a direct result.
The Cancer Center is proud to offer our patients the benefits of the most up-to-date treatments. Some of our cancer patients choose to participate in research studies called clinical trials. The decision to participate in a clinical trial is always up to the patient. You can be assured the Cancer Center will provide the highest quality treatment and outstanding care whether the patient chooses to take part in clinical trials or to receive standard treatments. Research is the single most important element in the fight to cure cancer.
Every cancer treatment offered today is a result of research. The Research Assistance Program is our financial commitment to clinical research, allowing us to be one of the first to offer new cancer treatments to our patients. It requires tremendous commitment on the part of physicians and patients. But commitment alone cannot achieve success because research is costly.
Currently, more than 200 Cancer Center patients are involved in research studies, an impressive record of accomplishment that must continue and expand if new treatments are to be developed and tested. Research funding of at least $200,000 per year is required to sustain current studies. As part of its overall, long-term plan, a key goal of June E. Nylen Cancer Center is to establish a $5 million endowment fund that will generate $250,000 to $300,000 annually to help support research for the future, as well as services needed by patients today.