Clinical Trials

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.

Although there is always a chance that a new treatment will be disappointing, 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.

What is a clinical trial?

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, 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.

Screening Trials: Test new ways to find cancer, especially in its early stage.

Facts and Fiction

Choosing to participate in a study gives patients access to treatment and potential benefits from therapy 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.

Our Involvement

Both practices housed at the Cancer Center participate in clinical trials. Siouxland Hematology-Oncology Associates (SHOA) has been a research leader for more than 15 years and frequently partners with Siouxland Radiation Oncology in clinical trials. They are currently involved in 120 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.