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Clinical Trials

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What are Clinical Trials?

Clinical trials are research studies in which patients may volunteer to take part. St. Jude offers clinical trials to find better ways to prevent, diagnose and treat cancer. Doctors use treatment trials to learn more about how to fight cancer. This guide is for patients who may join a treatment trial.

Clinical trials are part of a long, careful process, which may take many years. First, doctors study a new treatment in the lab. Then they often study the treatment in animals. If a new treatment shows promise, doctors then test the treatment in people. Doctors do this in three to four steps, or phases. Your doctor may offer you a clinical trial as a treatment option.

How am I protected?

Our most important job is to protect patients. First, St. Jude protects patients in clinical trials by following well-planned protocols.

A protocol:

  • Explains the treatment plan
  • Lists the medical tests patients will receive
  • Gives the number of how many patients will take part in the clinical trial
  • Lists eligibility criteria, which are guidelines to decide who may join the clinical trial
  • Explains safety information

We further protect patients by using a careful informed consent process, and third, our Institutional Review Boards (IRBs) protect patients by reviewing protocols and monitoring trials. The IRBs are committees of doctors, nurses, chaplains, social workers, lawyers and patients. They make sure that trials follow federal laws and that patients are protected.

The U.S. Food and Drug Administration (FDA) audits the IRBs' files. Also, FDA officials may visit St. Jude Medical Center at any time and review anything they choose related to clinical trials.

To learn more about cancer clinical trials at St. Jude, please call Lavinia Dobrea, RN, BSN, Oncology Research Coordinator at (714) 446-5642 or email her at lavinia.dobrea@stjoe.org.

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What are the Phases of Clinical Trials?

A new treatment goes through several phases. Each phase has a different purpose:

  • Phase I trials test if a new treatment is safe and look for the best way to give the treatment. Doctors also look for signs that cancer responds to the new treatment.
  • Phase II trials test if one type of cancer responds to the new treatment.
  • Phase III trials test if a new treatment is better than a standard treatment.
  • Phase IV trials find more information about long-term benefits and side effects.

Most of the time, when you take part in a clinical trial, you will only be in that one phase of the study. Treatments move through the phases, but patients do not.

Phase I Trials

Test if a new treatment is safe in people. Doctors also find the best way to give the treatment.

The goal of a Phase I trial is to:

  • Find out if a new treatment is safe.
  • Find the best way to give the new treatment, such as by mouth or by vein.
  • See if there are signs that cancer responds to the new treatment.

Phase I trials usually include 15 to 30 patients who are divided into small groups. These groups are called cohorts. The first cohort receives a dose of the new drug. Doctors may collect blood or urine samples to measure drug levels in the patients.

If the first cohort does not have any severe side effects, then a new cohort receives a higher dose of the same drug. The dose increases with each new cohort until the doctors find the best dose for future testing. With each increasing dose, doctors test each patient to see if he or she is responding to the treatment. If the doctors find that the treatment is safe, then it will move forward to be studied in a Phase II trial.

Phase II Trials

Test if a new treatment works in one type of cancer.

Fewer than 100 patients usually join a Phase II trial. Even though the main goal is to see if the treatment works, doctors still closely watch patients' side effects. If the new treatment works, doctors may go on to study it in a Phase III trial.

Phase III Trials

Test if a new treatment is better than standard treatment.

Phase III trials may include hundreds to thousands of patients around the country or world. Each patient enrolled in a Phase III clinical trial has a chance of being in one of the following groups:

  • Control group – the group that gets the standard treatment
  • Study group – the group that gets the new treatment being tested

Doctors do not know if the new treatment is better than the standard treatment, but they believe it is as good and may be better.

How are patients put into groups?

A computer decides which patients are in the control group and which patients are in the study group. Patients have a chance of being in either group. The patient and doctor do not decide. It is random and due to chance alone. This helps to avoid bias in the clinical trial. (Bias happens when human choices affect a study's results.)

Would my doctor know which group I am in?

In single blind studies, patients do not know whether they are in the control or study group, but the doctor does. In double blind studies, neither the patients nor the doctors know which patients are in each group. (In case of an emergency, doctors can find this information in the study file.)

Would I be given a placebo?

A placebo is something that looks like medicine, but is not. If a placebo is used, it is given together with the best standard treatment. This allows doctors to compare standard treatment alone to standard treatment with a new drug. If there isn't a standard treatment, then the placebo may be given alone, but this is not common in cancer trials.

After the Phase III trial, the FDA reviews the clinical trial results to make sure the treatment is safe and effective for people to use. The FDA decides whether to approve the treatment so that it is available for all patients.

Phase IV Trials

In Phase IV trials, doctors study treatments that the FDA has already approved. The goal of Phase IV trials is to continue studying side effects of a new treatment.

To learn more about cancer clinical trials at St. Jude, please call Lavinia Dobrea, RN, BSN, Oncology Research Coordinator at (714) 446-5642 or email her at lavinia.dobrea@stjoe.org.

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Joining a Clinical Trial

Am I able to take part?

Not all clinical trials are right for all patients. A trial may be safe for one patient to join, but not safe for another. Each protocol has strict rules that doctors must follow to decide who may join the clinical trial. These rules are called eligibility criteria. This protects patients from getting treatment that may harm them. Eligibility criteria include information about:

You and your overall health

  • Age and gender
  • Results of medical tests
  • Medicines that you are taking
  • Any other health problems

Your cancer

  • Cancer type and stage
  • Other treatments you may have had
  • How long it has been since you were last treated

If you have found a clinical trial that you think you want to join, talk to your doctor to see if you are eligible to take part.

How do I sign up?

If your doctor offers you a clinical trial, you will first go through a process called informed consent. The goal of informed consent is to make sure you understand the clinical trial's plan. The doctor or research nurse will review the informed consent form in detail with you. This form explains the clinical trial's purpose, plan, risks and benefits.

This is a great time to ask questions. Try to bring a family member or friend to help you ask questions and write down answers. If you decide to join the clinical trial, you will be asked to sign the informed consent form. The doctor will also sign the form, and you will receive a copy.

Take time to make your decision. If you like, you may take the informed consent form home with you to review before signing it.

What should I look for on the informed consent form?

Look for the following information on your informed consent form:

Treatment

  • The reason for the clinical trial (what the doctors hope to learn)
  • Who is eligible to take part in the clinical trial
  • What is known about the type of treatment being studied
  • Possible risks and benefits (based on what is known so far)
  • Other treatments that may be options

Tests

  • Types of tests
  • How often you would need tests and meet with the doctor

Costs

  • Who pays for the costs of the clinical trial
  • If the clinical trial causes you to need more medical care, who pays for those costs

Other

  • A statement about conflicts of interest (any direct financial benefit to St. Jude Crosson Comprehensive Cancer Center or your doctor from the sponsor of the trial)
  • A statement about how your privacy is protected
  • Who to call if you have more questions

The informed consent process does not end once you sign the informed consent form. For example, your doctor must tell you if new risks or side effects of the treatment are found during the trial. Also, please be sure to ask any questions you may have at any time during the trial.

Who would be in charge of my care in the clinical trial?

Your doctor and nurse will still care for you. In a clinical trial, you will also have a:

Principal Investigator (PI)

The PI is usually a doctor. He or she runs the clinical trial and makes sure that the health care team follows the plan.

Research Nurse

The research nurse teaches patients about the trial and collects data from patients on the trial. The research nurse is a good contact if you have questions during a clinical trial.

Would there be any follow-up after the clinical trial?

Yes, you would continue to see your doctor for treatment and follow-up care.

Would I be allowed to quit the clinical trial?

All patients in clinical trials are volunteers. You can choose to quit a clinical trial at any time, but talk to your doctor first. Your doctor can tell you how quitting the trial might affect your health and if there are other treatment options. Your relationship with your health care providers will not be changed by your decision.

To learn more about cancer clinical trials at St. Jude, please call Lavinia Dobrea, RN, BSN, Oncology Research Coordinator at (714) 446-5642 or email her at lavinia.dobrea@stjoe.org.

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Making a Decision

As the patient, it is your decision whether to take part in a clinical trial. Ask as many questions as you need to ask until the answers are clear to you. Here are some questions you may want to ask your doctor.

What are the benefits and risks of being in a clinical trial?

Each clinical trial has its own benefits and risks. You may benefit from joining a clinical trial in one of the following ways:

  • If the new treatment works, you may be one of the first people to benefit.
  • You may be able to help future cancer patients.
  • The trial sponsor may pay for some of your medical care or tests. (Ask your patient access specialist about who pays for these costs before you agree to join.)
  • Cancer experts design the treatments used in clinical trials.

Some possible risks include:

  • Side effects may be worse than those of the standard treatment.
  • Side effects may occur that the doctor does not expect.
  • New treatments do not always turn out to be better than, or as good as, standard treatment.
  • As with standard treatment, the new treatment may not work for you even if it works for other patients.

What are my treatment options?

Treatment options may include:

Standard treatment

There are standard treatments or “best known” treatments for most types of cancer. Standard treatments change over time as doctors learn from experience and research. In some cases, the standard treatment may be no treatment at all. For example, standard treatment may be to watch the cancer and wait to see if it grows.

Clinical trials

Many clinical trials are for new medicines or treatments that the FDA has not yet approved; however, some trials study treatments that the FDA has already approved. In these trials, doctors may look at new ways to give the treatments, or study different doses. Also, doctors may test treatments in different types of cancer.

Both standard treatment and clinical trials may involve:

  • Chemotherapy
  • Surgery
  • Radiation
  • Combined treatments (more than one kind of treatment used together)
  • No treatment or delayed treatment

What is my prognosis?

Your prognosis is what may happen with your cancer and how your cancer might respond to treatment. It is important to ask your doctor about your prognosis. This may affect your choices about treatment. Ask your doctor how the both standard treatment and the clinical trial might affect your prognosis.

Who pays for the clinical trial?

All trials are different. A clinical trial’s sponsor may pay for the new treatment, extra tests and extra doctor visits needed for the trial. The clinical trial sponsor may be:

  • UCLA Translational Oncology Research International (TORI)
  • City of Hope
  • A drug company
  • A non-profit organization

Your health insurance should pay for tests and doctors' visits that you would need even if you were not on the trial. Please ask us to explain how your insurance benefits apply to clinical trials and to learn more about what you might have to pay.

To learn more about cancer clinical trials at St. Jude, please call Lavinia Dobrea, RN, BSN, Oncology Research Coordinator at (714) 446-5642 or email her at lavinia.dobrea@stjoe.org.