Frequently Asked Questions

 Wilmot Cancer institute patients may be offered several treatment options for their type and stage of cancer. One option may include participation in a clinical trial, and often, clinical trials are the best option.

Clinical trials – sometimes called “clinical studies” or “research protocols” -- seek to answer questions that may lead to better ways of preventing, diagnosing, and treating cancer.  Clinical trials can also study ways to improve quality of life, behavioral and psychosocial impacts of cancer and genetic questions that researchers would like to answer.

Wilmot’s clinical trials are developed and sponsored by our own physicians and researchers, major pharmaceutical companies, or national cooperative programs funded by the National Cancer Institute (NCI). Most trials have eligibility requirements, which can be explained by your doctor, oncology nurse, or clinical study coordinator.

Choosing to participate in a clinical trial is an important, personal decision and one that only a patient can make with the help of physicians, family members and friends.

The purpose of clinical trials is to develop treatments that improve the standard of care and a patient’s quality of life. Standard of care is defined as the best treatment we have today, based on previous research. Today’s clinical trials will lead to tomorrow’s standard of care. 

Wilmot offers many different types of clinical trials including:

• Treatment- These trials test new cancer drug therapies, new combinations of drugs, or new approaches to surgery or radiation therapy.
• Prevention- The goal is to prevent cancer in people who have never had the disease or to prevent cancer from returning. Prevention trials may include medicines, vaccines, supplements, or lifestyle changes.

• Diagnostic- These trials are designed to find better tests or procedures for diagnosing cancer.
• Screening- This type of trial evaluates the best ways to detect certain cancers.
• Quality of Life- Trials in this category explore ways to improve comfort, supportive care, quality-of-life, and survivorship for cancer patients.

Researchers conduct clinical trials in phases:

• Phase I tests an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects;
• Phase II studies are conducted in a larger group of people (100-300) to see if the treatment is effective and to further evaluate its safety;
• Phase III studies are conducted in large groups of people (1000-3000) to confirm the treatment’s effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely

Every study has eligibility requirements designed to recruit patients that will best answer the research question at hand.  These requirements ensure that patients are similar in age, type and stage of cancer, general health, and previous treatment. When all participants meet the same eligibility criteria, it gives researchers greater confidence that results of the study are caused by the intervention being tested and not by other factors.

If you qualify for enrollment and decide to participate in a clinical trial, the clinical study team will discuss it in detail and review a consent form that fully describes the study. After you have had time to ask questions, you will be asked to sign the consent form for participation. Patients can withdraw from a clinical trial at any time, for any reason.

The benefits of participating in a clinical trial include:

• Access to new treatments that are not available as standard options;
• If the new treatment is proven to be more effective than standard therapy, you may be one of the first to benefit;
• Close monitoring by your physician and the research team;
• The opportunity to make a difference and improve treatments for future generations

Treatment risks and side effects exist with both standard care and clinical trials. Many safeguards are in place to protect patients in clinical trials. All therapies being evaluated in clinical trials have already been carefully studied in a laboratory and were determined to have potential value for patients.   

Once a patient decides to register for a clinical trial and treatment begins, he or she is carefully monitored by physicians, research nurses, and clinical staff.  Blood tests, x-rays, and other procedures are performed regularly to detect and record any health changes.

Institutional rules at the University of Rochester and federal regulations are in place to protect patients who take part in clinical trials. For example, any research involving patients at Wilmot first must be approved by the Institutional Review Board (IRB). The IRB is made up of doctors from different specialties, ethicists (often a chaplain), administrators, and members of the community.  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. The IRB is authorized to review, require changes to, approve, or disapprove research studies.

Through a process called” informed consent,” a patient is given ample time and opportunity to ask about details of the trial before deciding to participate.

Before enrolling, patients should clearly understand the objectives of a trial and should realistically plan for all possible outcomes, including a disappointing result or even death. No one is ever placed in a study without his or her knowledge.