Day 15 – CLINICAL TRIALS for LUNG CANCER
Clinical trials are research studies that look at new ways to prevent, detect, or treat disease. Some involve testing of a new medical device, pharmaceutical, or other treatment option may be more effective than currently available options. Some trials test theories about cancer prevention, or study the life span post-treatment to learn about long-term efficacy of a technique or pharmaceutical. All involve a set of standards by which the study is managed to determine if the theory, device or drug actually help, in what circumstances, and how to best use such in a specific group of people.
- What tests and treatment would I receive? It is important to know that in a clinical trial, you will not receive less than the ‘standard of care’ or what is currently considered to be the best practice. For example, if you are participating in a drug trial, you will either be given the new drug being tested OR the currently approved drug/s your oncologist would be choosing for you even if you were NOT in the trial. Diagnostic testing would include the current standard of care, even if new methods or devices were to be added for evaluation.
- What does a clinical trial “phase” mean? There are four phase to a clinical trial:
- Phase I occurs after much lab testing (and possibly testing on animals) to test if a drug is safe for humans. Researchers evaluate safety, side effects, and how the drug is absorbed, metabolized and excreted. About 70% of experimental drugs move past this stage.
- Phase II trials test the effectiveness of the device or drug. There is a control group who receives the current best medications and a test group who receives the experimental drug. Frequently the participants and researchers do not know which group the patient is in (called a ‘double blind’ study). This phase can last up to a few years.
- Phase III trials include randomized, blind studies of several hundred or thousands of participants. Researchers and the FDA collect data about the drug’s effectiveness and potential side effects before bringing the new drug to market.
- Phase IV “post marketing surveillance trials” take place to monitor a drug’s long term effectiveness and impact (as it may take years for longer-term side effects to appear), and to compare it to other trials and drugs in the market.
- What are the benefits & risks? If you choose (and are deemed eligible for) a Clinical Trial, you may be among the test group receiving a new drug or treatment that may be superior to the currently used best treatment. Sometimes, these trials can also be free of cost to you, or you may even be paid to participate. However, the potential treatment might not work as anticipated, unexpected side effects may occur, and the test treatment being evaluated may have risks yet unknown to humans, even though it has been evaluated for years in the lab by researchers. Speak in depth with your doctor, study team, and family about as you weigh the benefits and risks of participating in any clinical trial.
- Will I be eligible? There are very specific eligibility and INeligibility criteria for all phases of all clinical trials. From your age, health history, genetic test results, type and stage of your cancer, what treatments you’ve had thus far, etc, there may be hundreds of standards you must meet to meet the eligibility requirements for each trial considered.
- There are hundreds of clinical trials taking place right now. After your conversations with your oncologist, he or she should be able to lead you to resources for registries and trials for which you may be eligible if you choose to investigate clinical trials for your needs.
RESOURCES: https://www.fda.gov/forpatients/approvals/drugs/ucm405622.htm, https://www.lungcancer.org/find_information/publications/163-lung_cancer_101/272-clinical_trials, https://lungcanceralliance.org/treatments-and-side-effects/clinical-trials/, https://www.cancer.gov/about-cancer/treatment/clinical-trials/search, and https://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials