Clinical trials provide participants with the opportunity to participate in cancer research and contribute to the development of new therapeutic approaches.
Talk to your doctor about the potential benefits and risks of joining a clinical trial and if you could be an appropriate candidate.
Clinical trials are studies that involve research to:
evaluate how well a new treatment works
discover what side effects it might have
learn how a potential new treatment may work in comparison to other available treatments
Health authorities, such as the United States Food and Drug Administration, use the results of these trials to decide whether a potential new treatment should be approved for use outside of a clinical trial.
Clinical trials follow carefully designed research plans, called protocols, that are developed before the trials begin.
Protocols determine:
who would be eligible for the trial
which established treatments or potential new treatments are being studied
what questions the researchers will try to answer
how participants will be cared for throughout the trial
We believe diversity in clinical trials is core to our responsibility to science and society in order to best understand how our potential new treatments affect different populations of people who may benefit from them. We are thoughtfully working to include a diverse group of participants across all our clinical trials globally and in the United States through both community-based and academic sites.
When a potential new treatment is studied, it is evaluated in stages, or “phases.” Each phase assesses the potential benefits and risks of the new treatment being studied. This approach provides progressively more data on participants’ responses over time. At every phase, health authorities, study sponsors, and others use the data—among other factors—to determine whether the study should progress to the next phase.
Phase 1 trials include a small group of participants, usually fewer than 100. Depending on the trial, participants may include healthy volunteers or people with specific health conditions.
Phase 1 trials study:
how a potential new treatment being studied works in the human body
side effects that might occur when someone takes the potential new treatment
the appropriate dosage of the potential new treatment that should be used in future trials
Phase 1 trials include a small group of participants, usually fewer than 100. Depending on the trial, participants may include healthy volunteers or people with specific health conditions.
Phase 1 trials study:
how a potential new treatment being studied works in the human body
side effects that might occur when someone takes the potential new treatment
the appropriate dosage of the potential new treatment that should be used in future trials
Phase 2 trials typically include 100 to 500 people. Phase 2 trials test the safety of the potential new treatment being studied and how well participants respond to it.
Phase 3 trials involve a larger group of participants, usually several hundred or more. Phase 3 trials can take years to complete since they often focus in part on the long-term effects of using the potential new treatment being studied.
Phase 3 trials often compare the potential new treatment being studied with current treatments available, also known as the standard of care. The goal is to evaluate the benefits and risks of the potential new treatment, including those compared to any treatments already available to patients.
Phase 3 is usually the last stage of research before a potential new treatment is evaluated for use outside of clinical trials by health authorities.
Phase 4 trials usually include thousands of participants and start once a new treatment has been approved for use. These trials study the long-term real-world use of a new treatment outside of a controlled clinical trial setting.
At Arcus, we design clinical trials with participants’ experience and safety in mind.
It’s important for participants to keep the following guidelines in mind:
Participants cannot choose the potential new treatment they receive, or the dosage level of the potential new treatment being studied
It is not yet known how participants may respond to the potential new treatment being studied, nor how the potential new treatment being studied will compare to currently available treatments
Taking part in a trial may require more doctor visits than usual to help monitor a participant's health and response to potential new treatment
Clinical trial participation is always voluntary. Participants have the right to leave the study at any time
If you would like to be part of an Arcus clinical trial, we encourage you to speak to your doctor about your enrollment eligibility. Once it is determined that you meet the main criteria to enroll, you can expect to go through a series of steps to ensure that the clinical trial is matched to your specific condition.
The research team will schedule an appointment to learn more about you and provide more details about the trial.
These include:
the trial’s purpose
potential benefits and risks
the length of your participation
an overview of the procedures
Before joining a clinical trial, you will need to sign an informed consent form that acknowledges your understanding of the benefits and risks of participating and what will happen during the clinical trial. It also identifies your rights and responsibilities, which include your ability to leave the study at any time.
Researchers will check your medical history and may conduct a physical exam and other tests to make sure that you meet all requirements for joining the trial. If you are not eligible for the clinical trial, you can ask your study doctor or primary oncologist about other options that may be appropriate for you.
If you qualify and decide to participate in a clinical trial, researchers will provide information on your participation as well as additional instructions on:
what you need to do at home
how often you will need to visit the trial site
what will be required during the visits (e.g., physical exams, questionnaires, additional procedures)
Your overall health and safety will be carefully monitored during the entire length of the study.
At the end of the trial, your study team may suggest that you meet with your primary oncologist to determine further care options. Some studies may allow you to continue using the potential new treatment that was studied. If you are a healthy volunteer, your participation in the trial will be complete.
Members of the Clinical Trial Team
The team is dedicated to monitoring the participant's response and safety throughout the trial and recording the outcomes.
Principal Investigator ("PI")
The Principal Investigator is responsible for leading the trial and supervising the team of doctors, nurses, and other healthcare professionals working at the clinical study site.
Study Coordinator
The Study Coordinator is responsible for managing the day-to-day activities at a clinical study site.
Independent ethics committee (or Institutional Review Board – “IRB”)
The independent ethics committee is responsible for monitoring the study, including to ensure that participants' safety and protection are closely followed.
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