Clinical Trials FAQ - SCOR - Southeast Clinical Oncology Research Consortium

Frequently Asked Questions

Click the questions to reveal the answers below.

What is a Clinical Trial?

Cancer clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose or treat cancers. People who take part in cancer clinical trials help researchers learn more about cancer and help develop improved treatments. The treatments that patients receive today are based on the results of clinical trials done in the past. It is important that men and women of all ages and backgrounds take part in these research studies so that what is learned will help cancer patients now and in the future.

Clinical trials often compare the most accepted cancer treatment (standard treatment) with a new treatment doctors hope will be better.

Each research study has rules about who can and cannot participate – such as age, sex or type of cancer. You should think about asking your doctor if you can take part in a research study. Your doctor and the research staff will explain the clinical trial to you. Clinical trials include only people who choose to take part. Please take your time to make your decision about taking part. You may discuss your decision with your friends and family. You may also discuss it with your health care team. If you have any questions, you can ask your doctor for more explanation about the clinical trials or research study.

Each research study has guidelines that describe the characteristics that all patients in the study must have. These guidelines are called eligibility criteria. Eligibility criteria differ from study to study, depending on the research purpose. Some examples of elibgibility criteria may include age, gender, the type and stage of cancer, and whether cancer patients who have prior cancer treatment or who have other health problems can participate in the study.

An important principle of medical research which helps produce reliable results is determining and following eligibility criteria. During a study, the eligibility criteria help protect patient safety, so that people who are likely to be harmed by study drugs or other treatments are not exposed to the risk. After the study is complete and results are evaluated, they help doctors know which patient groups will benefit if the new treatment being studied is proven to work or be beneficial. For instance, a new treatment may work for one type of cancer but not for another, or it may be more effective for men rather than women.

Why participate in a clinical trial?

Clinical trials are the only way to improve cancer care. The local hospitals, doctor offices, and cancer centers taking part in clinical trials do so to maintain high standards for cancer treatment. Before you join or participate in a research study, a doctor, nurse or research professional on the research team will explain why the study is being done and what will happen during the study. You or your family can ask questions about the research study.

You will be given a consent form to read. The consent form will explain:

The exact plan of each step of the research study
What side effects may be experienced
How the study may affect your daily life
The benefits of participation

You should discuss any concerns or ask any questions about any part of the consent form you do not understand. If you decide to take part in the research study, you will be asked to sign the consent form. Even if you sign the consent form, you can still change your mind and stop participating in the research study at any time.

If you join or participate in a research study that compares treatments, you will receive either:

The best accepted treatment for the kind of cancer you have (called standard treatment)
A new treatment doctors hope will be better than the standard treatment
What doctors learn in research studies also helps people who may get cancer in the future.

It is not known for sure if the new treatment in the research study will help you more than the standard treatment for your cancer. Treatment in research studies have side effects. Research studies have costs, and health insurance does not always pay for all your expenses in a research study. It is important to talk about these costs with your doctor, nurse or social worker.

Here are some questions you may ask before you agree to take part in a clinical trial:

Why is the research study being done?
How will the research study help me?
What kinds of tests and treatments are part of the research study?
How am I protected?
How could the research study change what I do every day?
What will happen to my cancer with or without this treatment?
What other treatments could I get if I don’t take part in the research study?
What are possible short-term and long-term side effects for me and my family to think about?
How do the risks and side effects of the standard treatment compare with the treatment being studied?
How long will the research study last?
Will my insurance cover my taking part in this research study?
Will I have to stay in the hospital during the research study? If so, how often and for how long?
Will I have extra costs because of the study?
How will I be followed after the study?
How much time do I have to make up my mind about joining this research study?

What are some of the possible benefits?

Clinical trials offer high-quality cancer care. In a study that offers standard medicines and a study drug, you could receive either option. If you do not receive the study drug, you will still receive the best known standard treatment. This may be as good as or better than the new approach.
If the new treatment works and you are taking it, you may be among the first to benefit.
By looking at the pros and cons of clinical trials and your other treatment choices, you are taking an active role in a decision that affects your life.
You have the chance to help others and improve cancer treatment.

What are some of the possible drawbacks?

If you receive standard care instead of the new treatment, it may not be as effective.
New treatments may have unknown side effects. Those side effects may be worse than those that occur with standard treatment.
Even if a treatment has benefits, it may not work for you. Even standard treatments do not help everyone.
There may be inconveniences such as more frequent office visits and testing, as well as time and travel commitments.

What are my rights if I take part in a clinical trial?

Taking part in the research study or clinical trial is voluntary. You may choose not to take part or may leave the research study at any time. Leaving the research study will not result in any penalty or loss of benefits to which you are entitled.

You will be told about new information that may affect your health, welfare or willingness to stay in the research study.

All trials are approved by other groups before the local hospital, doctor’s office or cancer center receives them. Groups of experts at the national and local levels approve research studies before they begin. The NCI and the Food and Drug Administration are examples of national groups that review trials. One of the most important groups is called an Institutional Review Board (IRB). An IRB is made up of people whose job is to review trials for safety, ethics, and protection of patients’ rights and assure they are conducted fairly. IRB members may include doctors, nurses, pharmacists, lawyers, chaplains, and members of the community. After the IRB approves the trial, it can then be offered to patients.

What are the costs of taking part in a clinical trial?

The costs of care in a clinical trial fall into two general categories:

1) Routine care costs:
Routine care costs are costs associated with treating a person’s cancer, whether or not he or she is in a clinical trial. These costs are usually covered by health insurance.

2) Research costs:
Research costs are costs associated with conducting a clinical trial. These costs may include the costs of extra doctor visits, extra tests and procedures that are required for the clinical trial, but they would not be part of routine care. If a clinical trial has research costs, then these items are provided at no cost. When the research nurse reviews the details of a clinical trial with you, the nurse will tell you if parts of your care are free.

In addition, a member of the finance team at your local hospital, doctor’s office or cancer center will review your insurance plan to determine if your plan allows for clinical trial participation. You may still take part in a clinical trial even if you do not have insurance.

You will not be paid for taking part in a clinical trial.

What happens if I am injured while on the study?

In the case of injury or illness resulting from taking part in the research study and needing medical treatment, please notify your study doctor. The sponsor of the clinical trial will not offer to pay for medical treatment for the injury or illness. Your insurance company may not be willing to pay for study-related injury. If you have no insurance, you would be responsible for any costs.

If you feel this injury was a result of medical error, you keep all your legal rights to receive payment for this even though you are in a clinical trial.

For more information on clinical trials or general information about cancer, you can visit the National Cancer Institute’s Web site at http://cancer.gov/. You may also call the NCI Cancer Information Service to get the same information at: 1-800-4-CANCER (1-800-422-6237).

A description of each clinical trial is available on http://www.ClinicalTrials.gov, as required by United States law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Will my medical information be kept private?

Your privacy is very important and the researchers will make every effort to protect it. Efforts will be made to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from the study is published or presented at scientific meetings, your name and other personal information will not be used. Researchers do their best to make sure that any information that is released will not identify you. Some of your health information from this study will be kept in a central database for research. Your name or contact information will not be put in the database.

A record of your progress will be kept in a confidential form at your hospital or doctor’s office where you receive treatment. There are organizations that may inspect your records. These organizations are required to make sure your information is kept private, unless required by law to provide information.

You authorize the use of clinical information contained in your records, but any publication which includes such information or data shall not reveal your name, show your picture or contain any other personally identifying information, except as otherwise required by law.

Are there different kinds of clinical trials?

Treatment: These clinical trials test new treatments and new ways of using current treatment. The treatments may include new drugs or new combinations of currently used drugs, new surgery or radiation therapy techniques. They also may include vaccines or other treatments that stimulate a person’s immune system to fight cancer. Combinations of different treatment types also may be tested in these clinical trials.
Prevention: These clinical trials test new treatments that may lower the risk of developing certain types of cancer. Most cancer prevention trials involve healthy people who have not had cancer. They often only include people who have a higher-than-average risk of developing a specific type of cancer. Some cancer prevention trials involve people who have had cancer in the past. These clinical trials test treatments that may help prevent the return of the original cancer or reduce the chance of developing a new type of cancer.
Screening: These clinical trials test new ways of finding cancer early when it may be easier to treat. There may be a better chance of long-term survival. Cancer screening trials usually involve people who do not have any signs or symptoms of cancer. These clinical trials are often limited to people who have a higher-than-average risk of developing a certain type of cancer because of a family history or a history of exposure to cancer-causing substances.
Diagnostic: These clinical trials study new tests or procedures that may help diagnose cancer more accurately. Diagnostic trials usually involve people who have some signs or symptoms of cancer.
Quality of life or supportive care: These clinical trials focus on the comfort and quality of life of cancer patients and cancer survivors. New ways to decrease the severity of side effects of cancer or its treatment are often studied in these clinical trials. How a specific type of cancer of its treatment affects a person’s everyday life also may be studied.

A program of the National Cancer Institute of the National Institutes of Health

ARE YOU A PATIENT

Looking for a Doctor?

ARE YOU A DOCTOR

Looking for a Clinical Trial?

Contact SCOR

Southeast Clinical Oncology
Research Consortium

2150 Country Club Road,
Suite 200
Winston Salem, NC 27104
T: (336) 448-1417
F: (336) 448-1425

Frequently Asked Questions

Contact SCOR

Member Communities