For Patients

Patients who enroll in a clinical trial at Montefiore Nyack Hospital receive their treatment from experienced staff focused on patient safety and care. There's a financial benefit for patients, who undergo study procedures that are paid for by the sponsor. All clinical trials at Montefiore Nyack are designed for patients to receive the standard of care, even if they're on the placebo arm of the trial. Moreover, our trials have withstood the strict standards of our hospital ethics committee.

Clinical trials are designed to answer questions about:

• Safety
• Benefits
• Side effects
• Whether some people benefit more than others

There are several kinds of clinical trials for cancer. Some of these studies test whether a new treatment is safe and works well. Others test ways to improve the quality of life for people with cancer. Certain kinds of studies follow patients to understand how their disease progresses.

For studies that involve new drugs, cancer researchers conduct a clinical trial only after testing the drugs in the laboratory. The most promising treatments are moved into clinical trials. As new treatments move through a series of steps called phases, researchers gather more information about the treatment, its risks and its effectiveness.

The most common types of clinical trials for cancer include:

• Cancer treatment trials test new drugs or new combinations of drugs. They also test new approaches to surgery or radiation therapy.
• Cancer prevention trials look for better ways to prevent cancer in people who have never had it, or to prevent the disease from returning. These studies may include medicines, vaccines or lifestyle changes, among other things.
• Diagnostic trials determine better tests or procedures for diagnosing a person’s disease.
• Screening trials test the best way to detect cancer.
• Quality-of-life trials (also called supportive care trials) look at ways to improve the comfort and quality of life of people living with cancer.

How might I benefit from participating in a clinical trial?

• You may have access to new drugs and other treatments before they're widely available.
• You’ll get regular and careful medical attention and will be monitored closely for any side effects.
• You’ll be playing an active role in your healthcare.
• You’ll be helping others by contributing to medical research.

What risks could I face by participating in a clinical trial?

• A clinical trial may require a lot of your time for treatments, exams or hospital stays. (Ask your doctor for information about the trial you are considering.)
• Even if a treatment is not harmful, it may not be effective.
• The treatment might cause serious side effects. Before deciding whether to participate in a clinical trial, you need to know what the potential risks might be. Ask your doctor.
• Even if a treatment helps some patients, it might not help you.

Is it possible I could get a placebo?

• A placebo is a pill or other substance that resembles the treatment being tested but has no therapeutic effect. If a placebo is part of the trial you’re considering, you’ll be told before you enter the trial. Placebos are not used if you would be put at risk by not having effective therapy. You would only be considered for such a trial when it’s safe and medically appropriate.
• All clinical trials at Montefiore Nyack Hospital are designed for patients to receive the standard of care, even if they're on the placebo arm of the trial. Moreover, our trials have met the strict standards of our hospital ethics committee.
• A placebo in cancer treatment is most often used when a standard treatment is available to patients and researchers want to compare that standard treatment to a new treatment.

Are there costs associated with being in a clinical trial?

Patients generally don't have to pay extra out-of-pocket costs for treatments studied as part of a trial. The clinical trial’s sponsor usually pays for all research-related costs and any special testing.

In many cases, patients or their insurance company are 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’ll receive an informed consent document that spells out exactly what your insurance will be required to pay for.

How do I know if I’m eligible to participate in a clinical trial?

If you’re interested in volunteering for a clinical trial, you’ll have to match “inclusion criteria.” These are the conditions you must meet to be included in a study. They may include your age, gender, the type and stage of your disease, previous treatments you received, and other medical conditions. In some studies, people who meet certain conditions cannot participate. These are known as “exclusion criteria.” 

Can I leave a clinical trial once I’m enrolled?

Yes. You can leave a clinical trial at any time and for any reason. You can always decide to refuse a particular treatment or test that's part of the study. In some cases, this means you won't be able to continue in the study.

Is it safe to be in a clinical trial?

Clinical trials are 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 made up of doctors, statistics experts and members of the community. This committee is responsible for reviewing research in order to protect the rights and safety of people who take part in research, both before the research starts and as it proceeds.

Once the trial is approved by the IRB, the organizers of the study must follow a careful plan, called a protocol, which describes exactly what will happen during the study. You’ll know the full details of the protocol before you join a clinical trial.

What is informed consent?

Before you decide whether to participate in a clinical trial, you’ll be provided with key facts about the study. This is called informed consent. Members of the research team explain details of the study, including the purpose of the study, how long it will last, what procedures are required, the potential risks and benefits of participating, information on the privacy of your medical records, and who to contact for more information.

This information is all written down in an informed consent document, which you can take home and refer to at any time. After reading through the document and asking any questions you may have, you’ll decide whether to sign the document. It isn’t a legal contract. Even if you sign it, you can still decide to withdraw from the study at any time, for any reason.

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