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