Frequently Asked Questions for Patients

Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose or treat diseases.

Yes. Cancer clinical trials differ according to their primary purpose: 

• Treatment. These trials test the effectiveness of new treatments or new ways of using current treatments in people who have cancer. The treatments tested may include new drugs or new combinations of currently used drugs, new surgery or radiation therapy techniques, vaccines, or other treatments that stimulate a person’s immune system to fight cancer.
• Prevention. These trials test new treatment or action that may lower the risk of developing certain types of cancer. Most cancer prevention trials involve healthy people who have not had cancer; however, they often only include people who have a higher than average risk of developing a specific type of cancer.
• Screening. These trials test new ways of finding cancer early. Cancer screening trials usually involve people who do not have any signs or symptoms of cancer. However, participation in these trials is often limited to people who have a higher than average risk of developing a certain type of cancer because they have a family history of that type of cancer or they have a history of exposure to cancer-causing substances (e.g., cigarette smoke).
• Diagnostic.These trials study new tests or procedures that may help identify, or diagnose, cancer more accurately. Diagnostic trials usually involve people who have some signs or symptoms of cancer.

For more information, visit https://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials/types

Benefits
Clinical trials give eligible participants the opportunity to:

• Have access to promising new treatment that is generally not available outside of a clinical trial. If the clinical trial provides more effective treatment, trial participants may be the first to benefit.
• Receive regular and careful medical attention from a research team that includes doctors, nurses, and other health professionals.
• Play an active role in their own health care.
• Help others by contributing to medical research.

Risks:  

• The new treatment being studied may not be better than standard therapy, or it may have harmful side effects that doctors do not expect or that are worse than those associated with standard therapy.
• Trial participants may be required to make more visits to the doctor than they would if they were not in a clinical trial and/or may need to travel farther for those visits.
• Health insurance may not cover all patient care costs in a trial.

To help you decide if you want to be in a study, U.S. Food and Drug Administration requires that you be given information about the study before you agree to take part. This is known as informed consent. 

The research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts, risks and potential benefits.The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

• 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?
• Who will be in charge of my care?

Plan ahead and write down your questions to ask. Ask a friend or relative to come along for support and to hear the responses to the questions. Many of these answers also will be contained in the informed consent document patients receive if they are eligible and considering participation in a clinical trial.

Every clinical trial has a protocol, or action plan, that describes what will be done in the trial, how the trial will be conducted, and why each part of the trial is necessary. Each study includes guidelines for who can and cannot participate. These guidelines are called eligibility criteria.

Eligibility criteria may include age, sex, medical history, and current health status. Eligibility criteria for cancer treatment trials often include the type and stage of cancer, as well as the type(s) of cancer treatment already received. Your doctor will make sure you are eligible for the study before you begin.

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. 

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. 

An IRB can stop a clinical trial if the researchers are not following the protocol or if the trial appears to be causing unexpected harm to the study participants.

For more information, visit:
https://www.cancer.gov/about-cancer/treatment/clinical-trials/patient-safety

A placebo is an inactive pill, liquid or powder that has no treatment value. 

The use of placebos as comparison or “control” treatments in cancer treatment trials is rare. If a placebo is used by itself, it is because no standard treatment exists.

In such a case, a trial would compare the effects of a new treatment with the effects of a placebo. More often, however, placebos are given along with a standard treatment. For example, a trial might compare the effects of a standard treatment plus a new treatment with the effects of the same standard treatment plus a placebo.

Be sure you understand what kind of study you would be entering and what it might mean for your treatment.

Yes, you may leave at any time.

Before joining a clinical trial, it is important to know how the costs of your care will be covered. Some clinical trials cover patient health care costs directly related to the research. Other costs of care may be covered by private or public insurance companies. To learn all the facts, be sure to discuss potential costs with your health care provider. Information regarding patient health care costes will also be reviewd with you in the Patient Informed Consent, prior to your participation in a clinical trial. 

For additional information on clinical trial health care costs, visit the links below:

For more information on insurance coverage visit:

https://www.cancer.gov/about-cancer/treatment/clinical-trials/paying

Medicare may assist with patient care costs:
Visit http://www.medicare.gov. 

https://www.cancer.gov/about-cancer/treatment/clinical-trials/paying/federal-programs

For more information on clinical trial coverage through The Department of Veterans Affairs:
Visit https://www.cancer.gov/about-cancer/treatment/clinical-trials/paying/federal-programs

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

In Phase I trials, researchers test 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.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its 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.

In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

https://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials/phases

• If your physician doesn’t raise the possibility of a clinical trial as a treatment option, ask your physician whether there is a clinical trial for which you might be eligible. 
• Review trials available through the Cancer Research Consortium of West Michigan or call program offices at (616) 391-1230.

You will receive information about a trial in which you’re interested; a personalized assessment, and answers to your questions. The staff will work with you and your personal physician to determine whether you meet eligibility criteria. If you meet the criteria and are still interested in participating in a clinical trial, you will be asked to review and sign a patient consent form detailing what will occur during the study, what your rights are as a participant and all known side effects of any medication.Once you enroll in a clinical trial, our staff will carefully monitor your progress.

Physicians who are involved in research through CRCWM are listed under "About Us", "Physician Investigators" tab.

• www.cancer.gov/clinicaltrials/search Search for clinical trials by cancer type and Zip code at the National Cancer Institute’s Web site.
• www.clinicaltrials.gov lists clinical trials for a wide range of diseases and conditions, including cancer. 
• www.cancer.org, the Web site of the American Cancer Society, offers a clinical trials matching service through a partnership with the Coalition of Cancer Cooperative Groups. Further information is available by calling
  1-800-303-5691