Before you decide if you should participate in a clinical trial, you should understand exactly what to expect and what will be expected of you. You may want to talk with your doctor about clinical trials in general or about a specific trial. The doctor working on a clinical trial will discuss all aspects of the trial with you, including the potential risks and you will have the opportunity to ask as many questions as you want. As a starting point, the following questions and answers may help you understand some of the basics about clinical trials.
A clinical trial is carefully supervised, monitored, and documented research that is done in humans before a regulatory authority approves a drug that is made available to the general public. Clinical trials help determine if study drugs, treatments, or devices are safe and produce desired results in treating or preventing a disease or other health condition.
KRAS is a protein that we all have in our bodies. Proteins are required for the structure and function of the body’s cells, tissues, and organs. The KRAS protein works like an on/off switch, relaying messages that tell cells when to grow and when to stop growing. KRAS G12C is a mutation of the KRAS protein. Sometimes a protein can become mutated (altered) and function abnormally. KRAS G12C causes the on/off switch to get stuck in the “on” position, leading to continuous and uncontrollable cell growth that can form tumors.
Amgen Oncology is continuing to research and learn more about a study drug called sotorasib which is designed specifically for cancers with the KRAS G12C mutation.
You, your doctor, or a member of the research team should check with your health plan to find out which costs it will cover.
Clinical trials follow a specific set of standards and are closely regulated to help protect study participants. An independent Ethics Committee or Institutional Review Board reviews and monitors each study closely to safeguard the rights and welfare of participants. Nevertheless, all clinical trials and study drugs have risks, including the potential to make participants sick or uncomfortable. Although safety precautions are put in place to protect people who participate in clinical trials, your condition or health could remain the same, improve, or get worse. Any known risks and side effects will be discussed during the informed consent process, but there may be unknown risks.
Clinical trials are conducted in phases.
Phase 1 trials are conducted to evaluate safety of a study drug, which includes collecting information about side effects. Phase 1 trials also identify what dosages of the study drug should be tested in additional clinical trials, if any.
Phase 2 trials evaluate effectiveness of the study drug and collect additional information about safety and side effects.
Phase 3 trials evaluate the study drug in large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.
Phase 4 trials take place after a drug is approved for use. These trials provide additional information including the drug’s risks, benefits, and best use.
Clinical trials rely on the cooperation of volunteer participants. While you are taking part in a trial, you will need to:
Activities can vary from visit to visit and may include the following:
If you choose to participate in a trial, we encourage you to communicate freely with the study doctor and staff throughout the trial. If you have questions or concerns about any aspect of the trial, you should feel comfortable discussing them with the study doctor at any time.
Taking part in a clinical trial is voluntary. If the study doctor determines that you qualify for participation based on a screening process, you may choose to participate or not participate. You will be given time and opportunity to ask questions before deciding what you want to do. Your decision will not affect current or future treatment you receive outside the trial. If you choose to participate, you will need to follow instructions and complete trial-related activities BUT you may leave the trial at any time for any reason without penalty or loss of benefits to which you are otherwise entitled.
You can visit any doctor to meet your health needs during a trial. You should tell other medical professionals you see that you are participating in a clinical trial and always communicate openly with the study doctor regarding other care you receive.
You may have already been tested for genetic mutations related to cancer. You can ask your doctor about this testing, which is called biomarker testing, to find out about the KRAS G12C mutation. You or your doctor can also contact Amgen for more information.
Your primary source of information about your health, or any health condition, should always be your doctor or another healthcare professional.