University of Vermont

College of Medicine

Vermont Cancer Center

clinicaltrials.html

Clinical Trials

The Vermont Cancer Center, at the University of Vermont and Fletcher Allen Health Care, provides a major resource for clinical trial activity in Vermont and surrounding regions. The VCC oversees the administration of a number of national and regional clinical trials for different cancer types. Each clinical trial looks for patients with a specific type and/or stage of cancer who are in a relatively good state of health. All patients enrolled in a particular clinical trial must be in a similar physical condition in order to accurately compare the results of experimental therapies. If you would like more information about clinical trials or participation in a clinical trial at the VCC, contact the clinical research supervisor at (802) 656-4414.

Clinical Trials Resources

Office of Clinical Trials Research serves as the main place to learn more about clinical trials research at UVM.

Clinical Trials Information from the NCI provides information about cancer research studies at sites nationwide.

The NCI Cancer Research Portfolio web site provices a structure for searching, organizing, and analyzing research supported by NCI by organ/cancer site and/or by broad area of scientific interest.

Center Watch is a clinical trials listing service that lists more than 41,000 industry- and government-sponsored clinical trials as well as new drug therapies recently approved by the FDA.

Coalition of National Cancer Cooperative Groups has information for physicians, patient advocates, patients, and families on cancer clinical trials.

Frequently Asked Questions

If you have a question that is not addressed here, please contact the VCC Clinical Trials Office at (802) 656-4414.

What is a clinical trial?

Clinical trials—also known as clinical studies or research protocols—are controlled studies that evaluate new ways to treat, prevent, or diagnose cancer. These studies are made possible when patients volunteer to try new or modified treatments. The term "clinical trial" comes from the fact that such studies try new treatments in a hospital or clinical setting.

What are the different phases of clinical trials?

Development of a new treatment progresses in an orderly series of steps, called phases. Clinical trials are usually classified into one of three phases.

Phase I trials involve a small number of human subjects who receive a new treatment that has already undergone rigorous testing in animals. The goal of Phase I trials is to determine the best and safest dosage and schedule of treatments for further studies.

Phase II trials involve larger groups of patients with specific tumor types and builds on the findings of Phase I studies. Because more subjects are involved, investigators may discover less common side effects and will continue to evaluate the safety of the treatment. During Phase II, the effectiveness of the treatment can also be estimated.

Phase III trials may involve hundreds of patients, often at several medical institutions. During this phase, the study treatment (alone or in combination) is compared to standard treatment methods. Some participants are given the experimental treatment (treatment group) while other participants receive the current standard treatment (control group). This allows researchers to compare the effectiveness of the experimental treatment with the standard treatment to determine if the experimental treatment is an improvement.

What is the purpose of a clinical trial?

The purpose of a clinical trial is to determine whether a new treatment option is safe and effective, and to improve treatment over current cancer therapies.

How does a clinical trial differ from standard care?

Clinical trials test the safety and effectiveness of new treatment options (new treatments or old treatments used in new ways) not yet approved for general use. Standard care is a non-experimental treatment option that has been proven effective and is currently being used. Likely, the standard care being used was proven effective based on past clinical trials.

What types of cancer treatments are studied in clinical trials?

Scientists study ways to prevent, detect, diagnose, control, and treat cancer. They may also measure the psychological impact of cancer and determine ways to improve a patient’s comfort and quality of life. Many clinical trials study new treatments; they may be studied alone or along with surgery, radiation therapy, chemotherapy, or newer types of therapies.

Are clinical trials safe?

Risks and side effects exist with almost any treatment whether it is standard care or a clinical trial. Clinical trials of new treatments may cause side effects. Researchers make every effort to discover and explain side effects to patients, however unanticipated serious side effects are a possible outcome from participating in a clinical trial. Many safeguards are in place to make clinical trials as safe as possible and protect patient rights. Before a new treatment is tried with patients, it is carefully studied in the laboratory. Laboratory research determines how best to use the new methods with people safely and effectively.

Any research involving people at the Vermont Cancer Center must be approved by the Vermont Cancer Center Protocol Review Committee and the University of Vermont Institutional Review Board (IRB). The IRB is made up of doctors from different specialties, ethicists (often a chaplain), administrators, and members of the public. An IRB is required by the U.S. Food and Drug Administration (FDA) to ensure protection of the rights and welfare of patients who are enrolled in clinical trials. Therefore, the IRB is authorized to review, require changes to, approve, or disapprove clinical trials.

Clinical trial patients are carefully monitored. Blood tests, x-rays, and other procedures are performed regularly to detect and record any changes, good or bad, in the patient’s condition. The monitoring provides scientists with valuable data for making patient care decisions and for documenting research results.

How do I know if I qualify for a clinical trial?

Your physician or nurse may suggest a clinical trial as part of your treatment plan. If you are interested in participating, the VCC Clinical Trials Office will help determine whether you are eligible to participate in a specific clinical trial. Every clinical trial has specific safety criteria that define which patients can participate in the trial. If there is a specific clinical trial you are interested in, you should discuss it with your physician. For more information about clinical trials at the VCC, contact the Clinical Trials Office.

Last modified September 08 2014 02:29 PM