About Cancer Clinical Trials

If you or someone you love is considering enrolling in a cancer clinical trial, you probably have several questions. Whether you need the answers to practical matters like whom to call to schedule an appointment about a given trial, to more complicated questions such as what are the pros and cons of enrolling in a clinical trial, you’ve come to the right place. Keep reading to find out all you need to know about cancer clinical trials.

What Is a Cancer Clinical Trial?

Clinical trials for cancer, also called cancer treatment or cancer research studies, test new treatments in people who have cancer with the aim of finding better ways to treat cancer. Clinical trials test many types of treatment such as: new drugs; new approaches to surgery or radiation therapy; new combinations of treatments; or, new methods, such as gene therapy.

Are treatments tested before cancer patients receive them in clinical trials?

A cancer clinical trial is one of the final stages of a long and careful research process. The search for new treatments begins in the laboratory, where scientists first develop and test new ideas. If an approach seems promising, the next step may be testing a treatment in animals to see how it affects cancer in a living being and whether it has harmful effects. Finally, studies are done with cancer patients to find out whether treatments that showed promise in the laboratory or with animals are safe and effective in people.

What’s the difference between a Phase I, Phase II, and Phase III Clinical Trial?

Each phase answers different questions about a new, experimental treatment.

• Phase I trials are the first step in testing a new treatment in humans. In these studies, researchers look for the best way to give an experimental drug (e.g., by mouth, IV drip, or injection; how many times a day). They also try to find out if and how the treatment can be given safely (e.g., best dose), and they watch for any harmful side effects. Because less is known about the possible risks and benefits in Phase I, these studies usually include only a limited number of patients who may not be helped by other known treatments.

• Phase II trials focus on learning whether the experimental drug has an anticancer effect (e.g., Does it shrink a tumor? Improve blood test results?). As in Phase I, only a small number of people take part because of the risks and unknown variables involved.

• Phase III trials compare the results of people taking the experimental drug with the results of people taking standard treatment (e.g., Which group has better survival rates? Fewer side effects?). Studies move into Phase III testing only after a drug shows promise in Phases I and II. Phase III trials may include hundreds of people around the country. Comparing similar groups of people receiving either the current standard of care treatment or the new treatment for the same type of cancer enables researchers to make sure that study results are real and caused by the treatment, rather than by chance or other factors. Also, comparing treatments shows clearly which one is more effective and/or has fewer side effects.

Why Are Clinical Trials Important?

Clinical trials are important in several ways. They contribute to knowledge and progress against cancer. If a new treatment proves effective in a study, it may become a new standard treatment that can help many patients. Today's most effective standard treatments (such as those for breast, colon, rectal, and childhood cancers) are based on previous study results. Clinical trials may also answer important scientific questions and suggest future research directions. Because of progress made through clinical trials, many people treated for cancer are now living longer.

Clinical trials can also offer an immediate benefit to participating patients. Trial subjects get up-to-date care from cancer experts and receive either a new (experimental) or the best available standard treatment for their cancer. In the past, clinical trials were sometimes seen as a last resort for people who had no other treatment choices. Today, patients with common cancers often choose to receive their first treatment in a clinical trial setting.

How do you know if a clinical trial is right for you?

There are benefits and drawbacks to enrolling in a clinical trial, and it’s important to learn both before making a decision.

There are many pluses to clinical trials. They offer high-quality cancer care. Even those study subjects who do not receive the experimental option being tested receive the best standard treatment which may be as good as, or better than, the new approach. If an experimental option is proven to work and you are taking it, you may be among the first to benefit. Moreover, even if you do not benefit personally, your participation in a trial may further cancer treatment options for others in the future.

Now, for the possible drawbacks. Although new treatments must show promise before they can be tested in cancer patients, experimental options under study are not always better than, or even as good as, standard care. They may have side effects that doctors do not expect or that are worse than those of standard treatment. Even if an experimental drug has benefits, it may not work for you. Even standard treatments, proven effective for many people, do not help everyone. Health insurance and managed care providers do not always cover all patient care costs in a study. What they cover varies by plan and by study. To find out in advance what costs are likely to be paid in your case, talk to a doctor, nurse or social worker involved in the study.

Note that, if you do enter a trial, doctors and nurses will follow your response to treatment carefully the entire time. If researchers learn that a treatment harms you, you will be taken off the study immediately and, at that time, your doctor will discuss other possible treatment options.

Why is Informed Consent an Important Part of Enrolling in a Clinical Trial?

Before and during a cancer treatment study, you have a number of rights intended for your protection. One of your key rights is the right to informed consent, which means that you must be given all the facts about a study before you decide whether to take part, including details about the treatments and tests you may receive and the possible benefits and risks they may have.

If you agree to take part in the study, you will be asked to sign this informed consent form. The informed consent process continues throughout the study. For instance, if during the trial any new findings (including risks) are discovered, you may be asked to sign a new consent form. You have the right to leave a study at any time. If you choose to leave, you will have the chance to discuss other treatments and care with your own doctor or a doctor from the study.

How do you learn about clinical trials at Hopkins that are recruiting patients?

You can learn about openings for clinical trials taking place at the Kimmel Cancer Center by perusing this section of the website or by calling our clinical trials information line at 410-955-8804.

How do you find out if you’re eligible to participate in a clinical trial at Johns Hopkins?

Our team of cancer experts determines, after a thorough evaluation, whether you are eligible for one of our clinical trials. This involves a careful review of your medical records and possibly some testing (such as blood work) to determine eligibility. For new patients to the Kimmel Cancer Center, this will require a new patient consultation appointment. To schedule this appointment, please call 410-955-8964, and select option 2.

Can you participate in a clinical trial at Johns Hopkins if you are not a patient there?

Yes. If you are not currently a patient at Johns Hopkins, you will first need to make an appointment for an evaluation at our Baltimore campus. You will meet with members of our oncology team who will provide you with a thorough physical examination and a review your medical records. In some cases, we may need to order additional tests performed here at Johns Hopkins before deciding the course of treatment or whether you are eligible for a particular clinical trial.

You can make an appointment by calling our New Patient Referral Office at 410-955-8964. Choose option #2 when prompted to schedule an appointment.

What if I do not live in Baltimore?

Patients outside of the Baltimore area are welcome to participate in clinical trials conducted here. But it is usually important for patients in a trial to spend a lot of time in Baltimore while on a trial. Members of our research team must administer drugs or procedures to patients, carefully and uniformly document all procedures, and closely monitor participants at all times. If you live out of town, our study team will review the trial schedule with you to help you decide whether it is practical for you to enroll in it. 

Our housing coordinator works with out-of-town patients to locate temporary housing. Call 410-614-6527 for assistance.

What are the costs of participating in a clinical trial and who pays for it?

The costs of participating in a trial vary, and may be covered in part by one or more of the following sources:

• The sponsor of the trial (for example, National Cancer Institute) may pay part of the costs
• The Kimmel Cancer Center may pay part of the costs, such as blood tests and tumor samples
• Patients’ health insurance, Medicare, or Maryland Medicaid may pay for part of it.

Some health insurance plans do not cover the costs of medical expenses that they consider “experimental" or "investigational" procedures, such as those associated with a clinical trial.

It is important to find out if your health insurance plan will pay for your participation in a clinical trial in advance of enrolling in one. Our study team submits insurance clearance for each patient. Also, if you need further assistance, our trained counselors at the Johns Hopkins Financial Counseling Services Department can answer questions about insurance coverage or billing for clinical trials at 410-955-8995.