Clinical Trials

Almost every day we hear about clinical trials for cancer. But it isn’t until cancer hits close to home that questions like these come up: What are clinical trials? Why are they important? What happens when you participate? What are the pros and the cons of being involved in a clinical trial? One of the goals of the USCLC is to develop clinical trials for the prevention, diagnosis and treatment of cutaneous lymphoma. Through clinical trials, we can offer patients some of the most sophisticated cancer treatments available.

What are Clinical Trials?
Clinical trials are studies that help evaluate new cancer treatments. Clinical trials are used to find better ways to help and to treat cancer patients. Clinical trials can involve the testing of:

• The latest drugs
• Novel approaches to surgery or radiation therapy
• Combinations of treatments
• New methods, such as gene therapy
• New treatment approaches using standard therapyA clinical trial is one of the final stages of a long and careful research process. The search for new cancer treatments begins in the laboratory, where scientists develop and test new ideas. If an approach seems promising, the next step may be testing it in the laboratory. Testing is done to see what the effect of the treatment is and to determine whether the treatment has harmful side effects.

Of course, treatments that work a certain way in the laboratory don’t necessarily work that way with people. That’s why clinical trials are done with patients – to find out whether promising treatments are safe and effective. “Standard of care” therapies given today are a result of information gained from clinical trials.

Phases of Clinical Trials
Clinical trials are conducted in four phases. Progressing to the next phase requires that researchers carefully study the results of the previous phase. Following is an overview of each phase of a clinical trial:

• Phase I clinical trials are the first step in testing a new treatment in humans. Phase I clinical trials are designed to study how the human body reacts to the treatment and what side effects might occur at different dosages. Because Phase I trials may carry significant patient risk, only a small group of patients participate, and then only those who likely would not benefit from more traditional treatments.
• Phase II clinical trials are designed to continue to explore the safety and how well the drug works in a larger group of patients. Some phase II studies focus on answering the question what is the best dose and dosing frequency of the drug and others focus on the efficacy of the drug at a predetermined dose and dosing schedule. Some Phase II studies are randomized clinical trials where some patients receive drug and the others receive either placebo or standard treatment.
• Phase III clinical trials involve large numbers of participants and help researchers decide if a new treatment is as good as, better than, or inferior to the best available standard treatment. Phase III clinical trials compare the results of people taking a new treatment with the results of people taking the best available standard treatment.
• Phase IV clinical trials are conducted after a treatment has been approved by the Food and Drug Administration (FDA) and is being marketed. These studies may be quite large if they are conducted for continuing safety surveillance. They can also include trials required by the FDA or studies done by the sponsoring company to answer some particular question about the usefulness or safety of the drug.Having a physician suggest a clinical trial does not necessarily mean that it’s a last-resort treatment option for the patient. It simply means that the physician thinks society or the patient may potentially benefit from the treatment being studied.
Why are Clinical Trials important?

Clinical trials for cancer are important for two reasons: 1) they contribute to the knowledge of and fight against cancer; 2) they may benefit individual patients by helping them feel better, live longer or cure the disease. Much of what we know today about cancer treatment is a result of what was learned from past clinical trials. Clinical trials may answer important scientific questions and suggest future research directions.

In a clinical trial of a treatment for cancer, patients receive the most current cancer care available from cancer experts. They receive either a new treatment that’s being tested or they receive an approved standard treatment for their cancer. Because clinical trials deal with a very serious disease, there’s no guarantee that either the new treatment or the standard treatment will produce the hoped-for results.

Although new treatments have unknown risks, a new treatment may prove to be as effective or more effective than the best available standard treatment. If so, patients participating in clinical trials are among the first to benefit. Patients receiving standard treatment often benefit from the trial, too.

What Happens in a Clinical Trial?
When a person participates in a clinical trial, they receive excellent care from a team of physicians, nurses, social workers and other health care professionals. Since a patient’s progress is followed closely, the patient may have additional office visits, laboratory tests and hospital stays. Before deciding to participate in a clinical trial, a patient should check with his/her insurance provider to see if these costs are covered by their plan.

In clinical trials, research concerns are important, but patient well-being is most important. Participants receive excellent care from physicians who are sensitive to the experience of a clinical trial participant. Clinical trial participants go through a process of informed consent, during which they learn about the clinical trial, including the benefits and risks. Participants are asked to sign a consent form and should keep a copy of it for later reference. Patients have other rights, including the right to:

• Leave the clinical trial at any time—even after it begins
• Be taken off the study if physicians learn during the trial that the treatment is inferior or toxic
• Have their health monitored throughout the duration of the clinical trialUnderstanding patient rights is very important. Part of that is having an understanding of a clinical trial’s built-in patient protections.

Each clinical trial has an action plan or protocol that explains how the trial will work. The study’s investigator prepares a protocol for the study. The protocol outlines what will be done in the study and why. It notes how many people will participate and what medical tests will be given and how often. It also details the treatment plan. Each physician that takes part in the clinical trial uses this protocol.

For patient safety, each protocol must be approved by the organization that sponsors the study (such as the National Cancer Institute) and an Institutional Review Board (IRB). An IRB is a group of physicians, healthcare providers, consumers and others who are selected to insure that the patient is not harmed by participating in a clinical trial. They may only participate in the oversight of the clinical trial if they have no personal interest or relationship to the study or its sponsor and thus can be considered unbiased.

A Clinical Scientific Review Committee (CSRC) assures critical and fair scientific review of clinical trials that have not previously undergone external peer-review. CSRC membership includes clinicians, basic scientists, a cancer control specialist, a geneticist, biostatisticians, a nurse and a research pharmacist.

Should I Take Part?
This is a personal decision. Patients should talk with their physician and the people closest to them. The information that follows may help as you think about your options. Before seriously considering participation in a clinical trial, one of the first questions should be: Am I eligible?

Participating in a clinical trial requires that you meet eligibility criteria. These criteria vary from study to study and may include age, gender and health issues, as well as the type and stage of cancer you have. It may also depend on whether you’ve had other cancer treatment or other health issues. Using eligibility criteria is an important principle of medical research because it helps produce reliable results.

Eligibility criteria also offer additional patient protections. People who are likely to be harmed by study drugs or other treatments should not participate in a clinical trial. Weighing the pros and cons of clinical trial participation can be helpful. While a clinical trial can be beneficial, it may have drawbacks, too. Here are some factors to consider:

• New treatments under study are not always better than, or even as good as, standard care.
• There may be unexpected side effects.
• The new treatment might not work for you.
• The standard treatment might not work for you.
• Your health insurance provider may not cover some patient care costs.Deciding to participate in a clinical trial is an important decision. If you’re considering participation in a clinical trial, make sure you get all the information you need to feel comfortable about your decision. You are the only one who can decide what’s right for you.