Clinical Trials Frequently Asked Questions

Clinical trials are research studies that involve people in order to assist doctors in finding new ways to improve treatments and the quality of life for people with certain diseases. Researchers design cancer clinical trials to test new ways to:

• Treat cancer
• Find and diagnose cancer
• Prevent cancer
• Manage symptoms of cancer and side effects from its treatment

Clinical trials can be an option for everyone, no matter what type or stage of cancer you or a loved one may have.

At CCR, most of our clinical trials are “early-phase” (phase 1 or phase 2). These trials may represent the first time a treatment or intervention is being tested in humans. New treatments may be entirely new drugs or interventions, a new combination of existing drugs or a new drug in combination with a standard of care treatment. The purpose of early-phase clinical trials is often to confirm that there are benefits to the treatment, to investigate its safety and side effects and to find the best dose.

In later, phase 3 trials, researchers investigate the new treatment alongside the current standard therapy to see if it works better and to compare any side effects or safety concerns. While phase 3 trials often contain hundreds or even thousands of patients, phase 1 and 2 trials are smaller, with anywhere from ten to one hundred patients.

CCR also offers “natural history,” or observational, trials. Participation in an observational study helps scientists learn more about diseases, especially ones that are rare. In these trials, the patient, and sometimes their family members, are followed over a long period of time to learn more about how specific tumors or cancers form and grow. Observational trials may also look at what genes cause cancer to develop at a high rate in certain families or search for clues to help prevent cancer or develop new cancer treatments.  

Anyone who meets the eligibility requirements can participate. U.S. citizens and permanent residents are given first priority. 

Because patient safety is of the highest concern, the NCI principal investigator and the research team make the final decision about enrolling a patient during the screening visit.

If you enroll as a participant on one of the Center for Cancer Research’s clinical trials all medical care received at the NIH Clinical Center in Bethesda, Maryland is provided at no cost to you. This includes  trial medications and hospital stays, if necessary.

If you do not live locally, you will also receive help paying for travel lodging expenses for your required visits.

Although not required, it is highly recommended that you maintain your health insurance coverage, if you have it, even while on a clinical trial at the NIH Clinical Center. While care related to trial participation comes at no cost to you, if you break your leg or come down with the flu, your insurance will help cover those trips to the doctor.  

Federal law requires most health insurance plans to cover routine patient care costs in clinical trials. You can read more about health insurance plans and general clinical trial costs on the NCI website.

There are several ways to search to see if one of our trials might work for you. You can:

• Search for clinical trials on our website
• Call 1-888-624-1937 to speak to one of our clinical trial specialists
• Email our clinical trial specialists at nciinfo@mail.nih.gov
• Submit an online form to our clinical trial specialists

Our providers can work as close partners with your doctor or healthcare provider if there are any trials you may be interested in.

Placebos (i.e., sugar pills) are rarely used in cancer treatment trials. No one is ever given a placebo when an effective treatment is available to treat his or her cancer. In very rare cases, a placebo may be used when testing a new drug if there is no known effective treatment for the specific cancer type or stage. If a trial does use a placebo, patients are always informed before taking part in the trial.

By considering a clinical trial as a treatment option, you are taking an active role in a decision that affects your life. Start by taking a close look at the trial; like all treatment options, clinical trials have possible benefits and possible risks.

Step 1. Talk to your Doctor/Health Care Professional

If you haven’t yet, we suggest that you review information about any clinical trial you find with your doctor or health care professional. You or your doctor may want to contact the investigator leading the clinical trial — or another member of the trial team — to discuss the trial, your medical history and your current health status. If you prefer, our doctors can reach out to yours directly, or together with you, to discuss clinical trial options.

Step 2. Schedule a Screening Visit

If it seems like you might be eligible for a clinical trial at CCR, a research nurse or doctor will help set up a screening visit for you either virtually or at the NIH Clinical Center in Bethesda, Maryland. The purpose of the screening visit is to determine if you are a candidate for a particular trial. You can decide later whether you want to participate in the trial.

If you need to travel to Bethesda, your costs will be supported. Before your screening visit, you will receive information about travel, hotels and paperwork to bring.

Step 3. Decide Whether to Enroll

The screening visit is similar to a consultation visit with a medical specialist. During the visit, you may be asked to have common diagnostic tests such as blood tests, a chest X-ray and an electrocardiogram (EKG). You will also have a chance to:

• Meet and speak with doctors, nurses and social workers on the research team
• Learn about the risks and benefits of the trial you are considering
• Ask questions about the trial

Before you decide to participate in the clinical trial, our medical team will review with you in detail the trial’s treatment schedule, possible benefits and side effects of participating, privacy and answer any of your questions. If you decide to participate, you’ll be asked to sign a consent form that contains all of this information.  

Signing the consent form does not mean you sign away any personal rights or protections. It simply indicates that you have read and understand the purpose and elements of the clinical trial and that you are participating voluntarily.

Possible benefits:

• Treatment trials offer the most advanced innovations and scientific thinking in cancer care.
• If a new treatment or prevention drug or regimen is successful, trial participants may be the first to benefit from it.
• Many people derive an emotional benefit from taking part in a trial that may help others who have cancer.

Possible risks:

• New treatments being studied are not always more effective than standard care. They may have similar or less effective results.
• Even when a new treatment or prevention approach has benefits, not every patient who receives the treatment will experience them.
• New treatments or prevention approaches may have unexpected side effects or risks.
• The trial may impose difficulties on lifestyle, such as getting transportation to the trial site, time off from work and childcare.

Our trials use many types of treatment and prevention methods, including:

• Antiangiogenesis: therapy that uses drugs to block the growth of new blood vessels to a tumor, cutting off the tumor's supply of oxygen and nutrients
• Bone marrow transplantation: a procedure that replaces bone marrow destroyed by high doses of anticancer drugs or radiation treatments
• Chemotherapy: treatment with anticancer drugs
• Hormone therapy: treatment that adds, blocks or removes hormones to halt or limit cancer cell growth
• Immunotherapy: treatment to stimulate or restore the ability of the immune system to fight infection and diseases, also called biological therapy, biotherapy or biological response modifier therapy
• Monoclonal antibodies: laboratory-produced substances that can locate and bind to cancer cells wherever they are in the body; each of the many monoclonal antibodies recognizes a different protein on certain cancer cells; monoclonal antibodies can be used alone, or they can be used to deliver drugs, toxins or radioactive material directly to a tumor
• Radiation therapy: use of X-rays, neutrons and other sources of high-energy radiation to kill cancer cells and shrink tumors
• Surgery: removal of a cancerous growth through an operation
• Vaccine: a substance or group of substances meant to cause the immune system to respond to a tumor or disease; a vaccine can help the body recognize and destroy cancer cells

Yes, you may withdraw from the clinical trial at any time.