Clinical Trials

Overview

Thousands of clinical trials evaluating new and more effective ways to prevent, diagnose and treat cancer are underway across the United States. Such crucial research fuels treatment advances that continue to transform cancer care, giving more people the chance to live longer and have better quality lives after a cancer diagnosis.

What Are Clinical Trials?

Clinical trials are structured research studies that test the safety and effectiveness of new medical approaches or interventions. They evaluate methods for disease prevention and patient screening; tools and procedures to diagnose disease; new or improved treatments such as drugs or drug combinations, medical procedures or devices; and lifestyle or behavioral changes that may improve health and/or quality of life.

These pages focus on treatment trials in which a new type of treatment, such as a drug, surgery or radiation therapy or a combination of them, is better than the current treatment. The standard cancer care therapies used today were once experimental treatments that were studied, evaluated and approved through this type of clinical trial.

These research studies are carefully planned and structured, and their design is rapidly evolving and expanding with precision medicine. This is a personalized approach to treating and managing disease that considers a person’s genetic variants and other factors unique to that individual. New types of clinical trials, such as the following, are being designed for this purpose.

Basket trials test the effectiveness of a drug on a single gene mutation/variant simultaneously across tumor types throughout the body. For example, trial participants will all have tumors with the same gene mutation, but the tumors may be in the breast, colon, lung, bladder or other locations.

Seamless trials are designed without the traditional distinct phases of a clinical trial. Instead, researchers combine Phases I and II or Phases II and III in a seamless transition that allows greater flexibility to expand the trial and potentially shortens the time involved in the drug development process.

Umbrella trials are designed with multiple treatment arms within the same study. Participants are grouped into a specific arm based on the type of cancer they have and its molecular profile.

Benefits of Participating

The potential benefits of a clinical trial include the opportunity to access leading-edge treatments not yet widely available. It may be an alternative if your current treatment isn’t working as well as it once was, or if you have a rare type of cancer that hasn’t been studied as much as others.

Additionally, you will receive a higher level of care during a trial because you will be closely monitored by the clinical trial medical team as well as by your regular oncologist. This extra attention may help identify and then treat side effects or other problems earlier. Even after the trial ends, you will remain in close contact with the team. Lastly, as you weigh treatment options, it is important to remember that participating in a clinical trial will not jeopardize your care.

Risks and Inconveniences

As with almost any cancer treatment, clinical trials can present potential risks or inconveniences. Ask your medical team about possible side effects and the number of medical visits and tests required. Clinical trials often have little flexibility because participants are required to follow the set protocols, which may affect the ability to work, attend class or meet other commitments. That’s why it’s important to make sure you can accommodate the schedule before you commit.

Informed Consent Process

When you’re considering a clinical trial, you will receive comprehensive information in a document known as an Informed Consent form. It details the purpose of the research, including your role in the trial, the treatment to be studied, how the trial will work, risks, benefits and other pertinent information. The form also discusses how you will be monitored, the potential side effects of the treatment, the current standard of care for your type and stage of cancer (regardless of the doctor or the institution in which you receive care), the safeguards in place to protect participants and how to withdraw from the trial at any time.

You will be given time during the Informed Consent process to study the information and get answers to any additional questions you may have. Before signing the form, check with your insurance provider to determine the procedures that are covered and those you will be required to pay out of pocket (see Financial Considerations).

Trial Participants Needed

A record number of cancer-fighting therapies is currently in development. The need is great for more clinical trial participants so these promising new treatments can be evaluated, formally approved and made available to the public. Talk to your health care team about clinical trials for your particular type, subtype and stage of cancer. Along with achieving your treatment goals, you may have the opportunity to help advance future cancer treatments.

 

The Four Phases of Clinical Trials

Clinical trials are traditionally designed in four phases, and each phase provides the building blocks of knowledge for the next phase. This approach allows researchers to ask and answer questions in a way that produces the most reliable information and provides the most protection of trial participants. The process also ensures that only treatments that have been rigorously studied are approved for the public.

Phase I evaluates a new drug (or other type of treatment) to see if it is safe for use in humans. The goal is to determine how the drug should be given, how often and at what dosage to be most effective for killing diseased cells while causing the fewest side effects.

Phase II determines how well a treatment works and how safe it is in a greater number of patients.

Phase III compares the new treatment with the current standard of care to see if it is more effective or has fewer side effects.

Phase IV tests a drug that has already been FDA approved for the market to gather more information about a drug’s effect in different populations and learn about side effects that may occur with long-term use of the drug.

The time it takes for the FDA to approve new therapies has been shortened considerably. Previously, approvals took about 10 years. Recently, based on successes of other trials, researchers have begun investigating and conducting seamless trials that begin in earlier phases. Today, the FDA considers approvals at any phase of research, including as early as Phase I trials, and approves therapies before many other organizations. These advances give patients access to life-saving treatments sooner.

 

 

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