Learn About Clinical Trials
Learn About Clinical Trials
A clinical trial is a research study that has progressed from a scientific question through laboratory testing and is now ready for human volunteers. Clinical trials are critical to the development of new lung cancer treatments, ways to ease the symptoms of lung cancer treatments, and collect tumor or blood samples for research. These new treatments may include drugs, surgical procedures, and new ways to manage side effects. The clinical trials process is overseen by the U.S. Food and Drug Administration (FDA), a local institutional review board (also known as an ethics committee), and a physician specifically trained to manage clinical trials.
A clinical trial may be referred to as a "research study," "study," or "trial." The team that manages the clinical trial is often referred to as the "clinical trials team," "research staff," or "study staff." Do not let the names confuse you as they all mean the same thing.
In order for a new drug to be approved by the U.S. Food and Drug Administration (FDA) for use in humans, it must pass through a rigorous testing process. This testing process is called a clinical trial and is composed of four different phases usually referred to as phases I through IV.
Phase I trials are the first level in which the researchers evaluate safety, determine a safe amount of drug, and identify side effects that might occur with the treatment. Before this phase, the treatment has already been researched at length in the lab and on animals and the drug has been determined to be ready for use in humans. The research team will adjust the amount of the treatment you receive at different intervals in the trial while monitoring the treatment's side effects. Typically, there may be only 20 to 80 people selected to participate in a phase I clinical trial. Usually these are patients with advanced stages of disease.
Phase II trials begin after a treatment has been found to be safe in phase I trials. During phase II, the research team will use a specific treatment, or combination of treatments, to determine the effectiveness for a specific type of cancer. A phase II clinical trial may include 100 to 300 people.
Phase III trials will be done when a treatment is found to be effective in phase II trials. During this phase, the treatment will be tested on a large number of patients comparing standard treatments (treatment you receive outside of the clinical trial) with the new treatment. If you participate in a phase III clinical trial, you may be randomly assigned to a control or test group. If you are assigned to the control group, you will receive the standard treatment for your specific type and stage of lung cancer. If you are assigned to the test group, you will receive the new treatment. Results from the two groups will be closely monitored by the research team to determine which treatment is most effective and the side effects of the treatment. Phase III trials include up to 3,000 patients.
Phase IV trials begin after the treatment has been approved by the FDA. In phase IV clinical trials, the treatment will be given to a much larger group of patients. In this phase, additional information will be gathered about effectiveness, side effects that might not have been previously identified, and safety issues that can only be identified in a larger group of participants.
Participating in a clinical trial may have several potential benefits for you. By participating in the trial, you will:
- Play an active role in determining the direction of your health care
- Have access to new treatments before they are widely available
- Receive expert medical care at leading health care facilities
- Help others by contributing to medical research
Before you agree to participate in a clinical trial, you should talk to your oncologist and the doctor in charge of the trial to make sure you understand the possible risks. You should understand that the treatment being used may not be better and side effects may be worse than the standard treatment. Because the treatment is new, your health care team may not know all of the side effects that you will experience. A clinical trial may require more time and attention from your health care team and from you than would a nonclinical trial treatment regimen. This extra time may include trips to the cancer center, more treatments, hospital stays, and complex dosage requirements.
In a study done in 1999, the American Society of Clinical Oncologists found that only 3% of adults with cancer participate in clinical trials. This low level of participation in clinical trials means that advances in cancer care do not happen as quickly as they might. Your participation in clinical trials can help to develop new cancer treatments for all cancer patients.
Any time you are facing a treatment decision, you should ask about clinical trials that might be appropriate for you. Clinical trials are not just for advanced stage lung cancer– clinical trials are available for all stages of lung cancer. Ideally, your entire health care team will be available to talk to you about new treatments that may be available. For example, your oncologist, radiologist, and surgeon may each have access to information about different clinical trials. Once you know about clinical trials that might be appropriate, you should discuss the options with your entire team who can help you understand the benefits and risks based on your specific lung cancer and health status.
There are thousands of clinical trials in the U.S. available to the cancer community; however, not all clinical trials will be available in your area. Clinical trials may be open at only one cancer center; others may be open in hundreds of cancer centers across the country. The number of participating centers depends on the disease being studied, the phase of the clinical trial, and the complexity of the clinical trial.
If you are interested in participating in a clinical trial, there are many sources of information. Here are a few:
- Your health care team (eg, oncologist, radiologist, pulmonologist) –ask your health care team if a clinical trial is appropriate for you at this time and what clinical trials are available at your center. If no trials are available at your center, ask your oncologist which investigation drugs or procedures might be right for you. With this information, you can search the government database for clinical trials in your area.
- The U.S. National Institutes of Health (NIH) list of clinical trials, which lists both federally funded and privately supported clinical trials. There are many other Internet sites with information on clinical trials, but they are generally built on information from the NIH.
The NIH clinical trial list includes over 136,000 clinical trials available worldwide, not just in the U.S. When you access the Web site, you should search for a clinical trial using the most specific information you have. For example, if your diagnosis is small cell lung cancer, search for "SCLC in the U.S." A list will open showing all of the studies that are in the database. In the listing, you will be able to tell the status of the clinical trial (eg, Completed, Recruiting, Not yet recruiting, Active). The list will include what conditions are being targeted in the trial and what treatments are actually being tested (eg, drug, radiation therapy). Clicking on the name of the study will open a new window that shows extensive information about the specific study, including how long the trial is expected to last, eligibility requirements, how outcomes will be measured, and contacts for the trial. If you find clinical trials that may be applicable to you, it is critical that you discuss them with your health care team.
Searching for clinical trials may be very confusing, since the resulting list may contain hundreds of possibilities. The Lung Cancer Foundation (LCF) can help with identifying clinical trials in your area that may be of interest to you.
Please Note: Much of this content is modified from the Lung Cancer Foundation's Navigating Lung Cancer handbook, which also covers general lung cancer information.