Research and Clinical Trials

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Below are some of our most commonly asked questions and requested information about clinical trials and cancer research.
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Find a Clinical Trial

Click here to view a list of cancer research trials that are currently enrolling patients at the June E. Nylen Cancer Center

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 successfully 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.

Clinical trials are a treatment option for many people with cancer. Many treatments used today are the result of past clinical trials. In cancer research, clinical trials are designed to answer questions about new ways to:

  • Treat cancer
  • Find and diagnose cancer
  • Prevent cancer
  • Manage symptoms of cancer or its treatment

What types of clinical trials are there?

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 Trials: Test new ways to control cancer side effects.

Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Who can participate in a clinic trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria.” These criteria are based on such factors as age, gender, the type and stage of disease, previous treatment history, and other medical conditions.

Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

What happens during a clinical trial?

The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses well as other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

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


Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

  • Play an active role in their health care.
  • Gain access to new research treatments before they are widely available.
  • Obtain expert medical care at leading health care facilities during the trial.
  • Help others by contributing to medical research.


There are risks to clinical trials.

  • There may be unpleasant, serious, or even life-threatening side effects to experimental treatment.
  • The experimental treatment may not be effective for the participant.
  • The protocol may require more of their time and attention the would a non-protocol treatment, including trips to the study site, more treatments, hospital stays, or complex dosage requirements.

What are side effects and adverse reactions?

Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

Who sponsors clinical trials?

Clinical trials are sponsored or funded by a variety or organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.

How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. In addition, healthcare personnel participating in clinical research must be certified in these ethical and legal guidelines. The trial follows carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will remain secret and will not be mentioned in these reports.

What should people consider before participating in a trial?

People should know as much as possible about the clinical trial and feel comfortable asking the members of the research health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

  • What is the purpose of the study?
  • Who is going to be in the study?
  • Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
  • What kinds of tests and experimental treatments are involved?
  • How do the possible risks, side effects, and benefits in the study compare with my current treatment?
  • How might this trial affect my daily life?
  • How long will the trial last?
  • Will hospitalization be required?
  • Who will pay for the experimental treatment?
  • Will I be reimbursed for other expenses?
  • What type of long-term follow up care is part of this study?
  • How long will I know that the experimental treatment is working? Will results of the trials be provided to me?
  • Who will be in charge of my care?

What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?

  • Plan ahead and write down possible questions to ask.
  • Ask a friend or relative to come along for support and to hear the responses to the questions.
  • Bring a tape recorder to record the discussion to replay later.

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.

Does a participant continue to work with a primary health care provider while in a trial?

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

How is the June E. Nylen Cancer Center involved in clinical trials?

Our physicians have been a research leader for more than 30 years. We are currently involved in 140 studies, bringing state-of-the-art scientific resources to the Siouxland community.

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 several major research group meetings.

The three primary groups with which we participate are:

  • The Alliance for Clinical Trials in Oncology (Alliance) with data management based at Mayo Clinic and includes a network of more than 10,000 cancer specialists contributing their expertise;
  • The ECOG-ACRIN Cancer Research Group is based at Harvard University. ECOG-ACRIN has roots as 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;
  • NRG, whose legacy includes being one of the first groups to undertake large-scale studies of breast cancer prevention and were instrumental in bringing Tamoxifen through FDA approval. NRG continues its pioneering research through affiliations with over 6,000 physicians and 300 sites in the U.S., Canada, and Australia.
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