Clinical Trial FAQs

Cancer clinical trials are research studies that involve people who participate voluntarily. Through clinical trials, doctors find new ways to improve cancer treatments by determining whether a specific treatment, drug, or procedure is a better way to treat cancer. Researchers can design cancer clinical trials to test new ways to reduce the risk, diagnose, or treat cancer. These types of clinical trials are also used to find better ways to manage cancer symptoms and treatment side effects.

Today, people are living longer lives from successful cancer treatments that are the result of past clinical trials. When you take part in a clinical trial, you add to our understanding of cancer and help improve cancer care for future patients. Clinical trials are the key to making progress against cancer and can lead to new, safer, more effective FDA-approved treatments.

There are four different types of clinical trials:

• Treatment trials, which test new treatments (drugs, medical procedures, combo treatments) or new ways of using existing treatments

• Prevention trials, which look at cancer risk and ways to reduce that risk by either doing something (called action studies), like making lifestyle changes, or taking something (called agent studies), such medicines, vitamins, or minerals

• Screening trials, which test new ways to find disease early, when it may be more easily treated

• Quality of life trials, which explore ways to improve comfort and quality of life for cancer patients

A protocol is a study plan on which all clinical trials are based. The plan states what will be done in the study and why. This also includes details such as how many people will take part in the study, what types of patients may take part, what tests they will receive and how often, as well as the treatment plan. The Principal Investigator and the sponsoring organization will carefully develop and review the protocol of the study. Next, it is reviewed and approved by an Institutional Review Board (IRB) to ensure trial procedures are consistently carried out. This protocol is used by every doctor taking part in the study.

There are many reasons why people choose to join a clinical trial. Some choose to participate because the treatments they have tried for their health problem did not work. Others participate because there is no treatment for their health problems. Being part of a clinical trial not only provides access to the latest in research therapies, but it also offers participants:

• More personalized medicine access to a cancer treatment that isn’t yet publicly available. This can include additional testing to assess specific genetic mutations or markers, or DNA sequencing, to inform a treatment approach.

• Free or low-cost treatment for the duration of the study.

• The opportunity to contribute to cancer research that may provide life-saving treatment to future cancer patients.

• A more active role in their own healthcare.

• Closer and more careful monitoring from some of the best cancer doctors, ensuring strict safety standards.

While there are benefits to participating in cancer clinical trials, there are some risks as well. Some possible risks that patients may face could include:

• As with any cancer therapy, the treatment being evaluated in the trial may not work for the participant.

• You may have to go to the cancer center for more appointments, as required by the trial. This can make some people anxious.

• You may have to do bloodwork or other tests more often than you would if you were receiving a standardized cancer therapy.

Since risks vary by individual situation, it’s important to talk with the research team at our offices in the Chicago area to understand the specific risks related to any cancer research trial you may be considering participating in.

No. Participation in a cancer clinical trial is completely voluntary at all times.

If you are interested in cancer clinical trial participation, you should know as much as possible about the study before you decide if taking part in a study is right for you. Our oncologists will thoroughly review clinical trial information with you before starting. This is called informed consent. It is important for you to ask any questions you have regarding the study, including its purpose, the procedures involved, the risks and benefits of participating, and the expenses you’ll face.

If you want to participate, you can view the clinical trials available at our Chicago-area cancer treatment centers, or talk with your oncologist about trials that may be available to you. They can help set up a meeting with a research coordinator or study investigator to learn as much as possible about the study. Remember, not every patient is eligible to participate. But if you're interested, it's worth the conversation.

There is a lot to learn regarding cancer research trials. Because of this, it’s a good idea to come to the meeting prepared with a list of possible questions to ask. You might also want to consider asking a friend or relative to join you for support and to hear the responses to the questions.

There are federal rules in place to help ensure the safety and ethics of clinical trials. Participants will be protected through:

• The informed consent process that allots time for each participant to be given the details of what they’re about to participate in. Each trial participant has to sign the informed consent to show they’ve been given the information.

• A careful review and approval of the clinical trial protocol by scientific experts and an institutional review board (IRB).

• Ongoing monitoring of the trial by the IRB, the research team, the organization sponsoring the trial, and the Data and Safety Monitoring Boards (DSMBs) for phase 3 trials.

There are two types of costs associated with a clinical trial: patient care costs and research costs.

• Patient care costs are those related to treating your cancer, whether you are in a trial or receiving standard therapy. These costs are often covered by health insurance. Doctor visits, hospital stays, standard cancer treatment, lab tests, and imaging tests are considered patient care costs in most cases.
  

• Research costs are those related to taking part in the trial. Often these costs are not covered by health insurance, but are usually covered by the research trial’s sponsor. Study drugs, as well as additional lab or imaging tests performed solely for the trial, are examples of research costs.

Taking part in a cancer research trial may require extra doctor visits that would not have been needed with standard treatment. During these visits, your doctor carefully watches for side effects and your safety in the study. These extra visits can add costs for transportation and child care, if needed.

Yes. Most clinical trials do not provide complete primary healthcare.

No. Typically, patients who decide to participate in a clinical trial keep their current oncologist since cancer research trials do not provide extended or complete healthcare. Maintaining a relationship with your oncologist helps ensure that the study protocol will not conflict with other medications or treatments that you are receiving.

Yes. Cancer research participation is strictly voluntary. If you no longer wish to participate, you may withdraw from the study at any time for any reason. When withdrawing from the cancer trial, you should let the research team know about it and the reasons for leaving the study.

Since trials available through Affiliated Oncologists are Phase II, III, or IV, we ensure you receive care as good as, or more effective than, the standard of care. Should the cancer treatment you’re receiving appear to be unsuccessful, your oncologist will suggest another cancer treatment option.

A blind clinical trial indicates that the patient does not know whether they’re getting the new treatment being studied or a standard cancer treatment. In some cases the researchers are trying to determine if the new treatment is better than what’s currently available without bias. Your oncologist will know which treatment you’re receiving.

A double blind clinical trial is one where neither the cancer researchers nor the patient know which treatment they’re receiving – the standard treatment for that particular type of cancer, or the new treatment being studied. Patients are randomly selected by a computer and placed in one group or the other. This helps further reduce bias about the results of the treatments.