Frequently Asked Questions

Below are some commonly asked questions regarding our cancer clinical trials. These trials are used to test how well new medical approaches work in people. With each clinical trial, we hope to find better ways to treat, prevent and screen for diseases.

What are clinical trials, and why are they important?

Clinical trials are research studies in which people choose to participate to help doctors find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer. People who take part in cancer clinical trials have an opportunity to contribute to knowledge of, and progress against, cancer. They also receive up-to-date care from experts.

What are the types of clinical trials?

There are several types of clinical trials:

Prevention trials test new approaches, such as medications, vitamins, or other supplements, that doctors believe may lower the risk of developing a certain type of cancer.
Screening trials review patient information to determine the best way to find cancer, especially in its early stages.
Diagnostic trials study tests or procedures that could be used to identify cancer more accurately. Diagnostic trials usually include people who have signs or symptoms of cancer.
Treatment trials are conducted with people who have cancer. They are designed to answer specific questions about, and evaluate the effectiveness of, a new treatment or a new way of using a standard treatment. These trials test many types of treatments, such as new drugs, vaccines, new approaches to surgery or radiation therapy, or new combinations of treatments.
Quality-of-life trials explore ways to improve the comfort and quality of life of cancer patients and cancer survivors. These trials may study ways to help people who are experiencing nausea, vomiting, sleep disorders, depression, or other effects from cancer or its treatment.

Who sponsors clinical trials?

Government agencies, such as the National Cancer Institute (NCI) and other parts of the National Institutes of Health (NIH), the Department of Defense, and the Department of Veterans Affairs, sponsor and conduct clinical trials. In addition medical institutions, foundations, volunteer groups, and pharmaceutical companies, also sponsor clinical trials.

How are participants protected?

Research is conducted according to strict scientific and ethical principles. Every clinical trial has a protocol or action plan for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. The same protocol is used by every doctor or research center taking part in the trial. All clinical trials at Beaumont Hospitals must be reviewed and approved by the Human Investigations Committee (HIC). The Committee reviews the protocol to make sure the study is conducted safely.

What are the eligibility criteria, and why are they important?

Each study's protocol has guidelines for who can or cannot participate in the study. These guidelines, called eligibility criteria, describe characteristics that must be shared by all participants. The criteria differ from study to study. They may include age, gender, medical history, and current health status. Eligibility criteria for treatment studies often require that patients have a particular type and stage of cancer. Eligibility criteria help researchers achieve accurate and meaningful results.

What is informed consent?

Informed consent is a process by which people learn the important facts about a clinical trial to help them decide whether to participate. This information includes details about what is involved, such as the purpose of the study, the tests and other procedures used in the study, and the possible risks and benefits. In addition to talking with their doctor or nurse, patients receive a written consent form explaining the study. Patients who agree to take part in the study are asked to sign the informed consent form. However, signing the form does not mean patients must stay in the study. Participation is always voluntary and patients may withdraw at any time.

How are clinical trials conducted?

Clinical trials are usually conducted in a series of steps, called phases. • Phase I trials: These studies evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. Because this is the first step of research testing in human subjects, a phase I trial usually enrolls only a small number of patients.

Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. A larger number of people are enrolled in this type of trial.
Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.
Phase IV trials: After a treatment has been approved and is being marketed, the manufacturer may choose to further study the effects. The purpose of phase IV trials is to evaluate the side effects, risks, and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials. Thousands of people are involved in a phase IV trial.

What are some of the possible benefits of taking part in a clinical trial?

The possible benefits of participating in a clinical trial include the following:

Participants have access to promising new approaches that are often not available outside the clinical trial setting.
The approach being studied may be more effective than the standard approach. • Participants receive regular and careful medical attention from a research team that includes doctors and other health professionals.
Participants may be the first to benefit from the new method under study.
Results from the study may help others in the future.

What are some of the possible risks associated with taking part in a clinical trial?

The possible risks of participating in a clinical trial include the following:

New drugs or procedures under study are not always better than the standard care to which they are being compared.
New treatments may have side effects or risks that doctors do not expect or that are worse than those resulting from standard care.
Participants in randomized trials will not be able to choose the approach they receive.
Health insurance and managed care providers may not cover all patient care costs in a study.
Participants may be required to make more visits to the doctor than they would if they were not in the clinical trial.

What are some questions people might ask their health care provider before entering a clinical trial?

It is important for people to ask questions before deciding to enter a clinical trial. Questions people might want to ask their doctor or nurse include the following:

The Study

What is the purpose of the study?
Why do the researchers think the approach being tested may be effective? Has it been tested before?
Who is sponsoring the study?
Who has reviewed and approved the study?
What are the medical credentials and experience of the researchers and other study personnel?
How are the study results and safety of participants being monitored?
How long will the study last?
How will the results be shared?

Possible Risks and Benefits

What are the possible short-term benefits?
What are the possible long-term benefits?
What are the possible short-term risks, such as side effects?
What are the possible long-term risks?
What other treatment options are available?
How do the possible risks and benefits of the trial compare with those of other options?

Participation and Care

What kinds of treatment, medical tests, or procedures will the participants have during the study? How often will they receive the treatments, tests, or procedures?
Will treatments, tests, or procedures be painful? If so, how can the pain be controlled?
How do the tests in the study compare with what people might receive outside the study?
Will participants be able to take their regular medications while in the clinical trial?
Where will the participants receive their medical care? Will they be in a hospital? If so, for how long?
Who will be in charge of the participants' care? Will they be able to see their own doctors?
How long will participants need to stay in the study? Will there be follow-up visits after the study?

Personal Issues

How could being in the study affect the participants' daily lives?
What support is available for participants and their families?
Can potential participants talk with people already enrolled in the study?

Cost Issues

Will participants have to pay for any treatment, tests, or other charges? If so, what will the approximate charges be?
What is health insurance likely to cover?
Who can help answer questions from the insurance company or health plan?

What happens when a clinical trial is over?

Research is an ongoing process that may result in improving or changing the standard of care. The researchers look at the data collected to make a decision about the meaning of the findings and determine if further research would be beneficial. Your participation in Cancer Clinical Trials at Beaumont Hospitals is valued and we will keep in contact with you for the remainder of your life.

The research that you participate in today leads to tomorrow's medical treatments and disease prevention strategies, which advances evidence-based health care. Find an open and enrolling clinical trial today with Beaumont's searchable clinical trial database, or by calling 248-551-7695.