Clinical Trial Frequently Asked Questions

What are the potential benefits of participating in a clinical trial?

You may gain access to new drugs and other treatments, sometimes years before they are widely available.

You will be monitored closely for any side effects.

You will have the chance to take an active role in your own healthcare.

You will be making a valuable contribution to cancer research.

What are the possible risks of participating in a clinical trial?
A clinical trial can sometimes require more time and medical attention than normal care. This can include doctor visits, phone calls, more treatments, a hospital stay, or a more complicated treatment regimen. (Ask your doctor for information about the trial you are considering.)

The treatment might not work.

The treatment might cause serious side effects.

Even if a new approach helps some patients, it might not help you.

What are the chances I will get a placebo?
A placebo is a pill or other substance that has no therapeutic effect. Many people think that clinical trials involve placebos, but only a small fraction of cancer clinical trials use them. If a placebo is part of the trial you’re considering, you will be fully informed of that fact ahead of time. You would only be considered for such a trial when it’s safe and medically appropriate.

A placebo in cancer treatment is most commonly used when a standard treatment is available to patients and we want to compare that standard treatment to a new treatment.

Do I have to pay to be in a clinical trial?
Patients generally do not have to pay extra out-of-pocket costs for treatments studied as part of a trial. Every trial is different, but the clinical trial’s sponsor usually pays for all research-related costs and any special testing.

Typically, the patient or his or her insurance company is asked to pay for any routine tests, treatments, or procedures that would be required as part of standard cancer treatment. Before you join a clinical trial, you will receive an informed consent document that spells out exactly what you’ll have to pay for and what you won’t.

At FWMOH, we have on-staff financial counselors who can help you manage any insurance and financial questions related to clinical trials.

How do I know if I’m eligible to join a clinical trial?
All clinical trials have guidelines spelling out who can participate. These are called eligibility criteria. The factors that allow you to participate in a clinical trial can include age, gender, the type and stage of your disease, previous treatment history, and other medical conditions.

Following eligibility criteria helps us keep you safe and ensures that researchers learn the information they need.

At what point during my treatment can I join a clinical trial?
You can look for clinical trials at any time during your care, from first diagnosis onward. At FWMOH, we encourage patients to consider a clinical trial from the very start of treatment if there’s one that’s right for them.
Can I quit a clinical trial?
Yes. You can leave a clinical trial at any time and for any reason.
Are clinical trials safe?
Every clinical trial 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.

FWMOH’s IRB includes doctors, nurses, statisticians, community advocates, and others who make sure that each clinical trial is ethical and that your rights are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that approves and periodically reviews the research to ensure your safety.

Once the trial is approved by the IRB, the organizers of the study must follow a careful plan, called a protocol, that describes exactly what will happen during the study. You will know the full details of the protocol prior to joining any clinical trial.

What does the “phase” of a clinical trial mean?
New treatments must pass through different phases before they can be released to the general public. If the treatment is successful in one phase, it will move to the next one. Patients typically participate in only one phase of a trial.
What is informed consent?
Informed consent is the process of learning about the clinical trial before you decide to take part in it. The research team running the trial will explain the trial’s purpose, how long it will take, what will happen, all potential risks and benefits, and information on the privacy of your medical records.

If you want to participate, you will sign a consent form that details all of the information that has been discussed with the research team. You will be able to take that form home and refer to it at any time. Even though you have signed the consent form, you still have the right to leave the study at any time and for any reason.

Informed consent continues throughout the trial. This will give the research team an opportunity to update you on the progress of the trial as well as any side effects or other risks that have been identified.

Why should I join a clinical trial at FWMOH?
Our dedicated researchers run one of the best clinical trial programs in Northeast Indiana in collaboration with TRIO-trials, University of Chicago phase II consortium and ALLINCE with an oversight of a compassionate and highly experienced staff recognized for their unparalleled focus on patient safety and care. Together with Inventa, we have been awarded the ASCO prize for clinical trials.
Where does FWMOH offer clinical trials?
All trials are currently offered at our Research Center located at 7910 W Jefferson Blvd Fort Wayne, IN 46804.