Clinical Trials

Our world-renowned doctors, scientists and researchers collaborate on more than 400 clinical trials each year, enrolling around 6,000 patients. By offering early access to clinical trials for qualifying patients, we bring breakthrough scientific research to patients diagnosed with many different types of cancer and create new evidence-based standards of care.

Types of Clinical Trials

Some of the most common types of clinical trials focus on:

• Preventing cancer in people who have never had the disease or preventing it from returning in people who have had cancer and recovered
• Creating better screening methods to help detect cancer earlier, which can make treatment for the disease more effective
• Developing new treatments or therapies for cancer by testing whether a new medication, vaccine or treatment technique is safe and effective
• Improving quality of life for patients by finding more effective ways to manage the side effects of cancer itself or the physical and/or mental health impacts of treatment and recovery

What Is a Protocol?

A study protocol is an outline or plan for how a clinical trial will proceed. Study protocols usually include information about who is eligible to participate and details on how the study will be run and for how long, along with information about which procedures or medications are being studied. 

Clinical Trial Phases

Most clinical trials take place over four stages, referred to as Phases 1 through 4. Each phase has a different goal, but in general, earlier phases are the first steps in developing a new treatment. 

• Phase 1 clinical trials are designed to assess how safe a new medication or approach is and to test its dosages and side effects. Most Phase 1 trials include around 20 to 80 participants.
• Phase 2 clinical trials include more people (100 to 300) and continue to test a treatment’s effectiveness and safety.
• Phase 3 clinical trials may include hundreds or thousands of participants and take place over the course of months or years. Phase 3 trials gather even more information about a treatment or medication, including how it works, how safe it is and whether it causes side effects.
• Phase 4 clinical trials occur after a new treatment has been approved for use by the U.S. Food and Drug Administration. At this stage, researchers can gather long-term data from an even larger group of participants to assess a medication’s effectiveness and effects on quality of life.

Clinical trials can offer new hope for survival or improved quality of life for patients with many different types and stages of cancer. Most clinical trials at City of Hope focus on finding better ways to prevent, detect or treat cancer or new options for managing its symptoms and side effects. Benefits to participating in a clinical trial include:

• Getting early access to new, potentially life-changing treatments
• Being an active participant in your cancer care
• Helping future cancer patients who may benefit from new treatments
• Receiving close, exceptional care from the clinicians involved in the trial

However, there are also risks that must be weighed against these potential benefits. These include:

• The possibility of side effects or health issues caused by the medications or new approaches being studied
• The risk that a new or experimental treatment does not prove to be effective
• More frequent and longer visits to a clinic or hospital
• The need to undergo additional tests or procedures

If you are interested in taking part in a clinical trial at City of Hope, your cancer care team can help you find out whether you qualify for any of our open clinical trials. If you do qualify, your team will provide a referral and introduce you to the clinical trial’s principal investigator, who is the scientist or physician in charge of the study. Even if you take part in a clinical trial, you will still receive care from your personalized cancer care team.

Qualifying Criteria

Each clinical trial has its own set of guidelines that includes eligibility criteria. To qualify for a clinical trial, a patient must meet these criteria. These may include certain demographics or medical history or having a specific type or stage of cancer.

How to Apply

If you are eligible to apply for an open clinical trial, your cancer care team will help you find out how to apply to take part. If you’re a City of Hope patient and wish to apply for an open clinical trial, you will need a referral from an oncologist on your care team. If you are not yet a City of Hope patient, you’ll need to schedule a consultation with one of our expert physicians before enrolling.

If you are interested in participating in one of City of Hope’s clinical trials and you meet the eligibility criteria, it is still important to talk to your cancer care team before deciding to enroll. Some questions you may want to ask your doctors include:

• How will the study work, and what will I be required to do during the clinical trial?
• Will I have to stop my current treatment plan during the trial?
• Is participation in a trial covered by my health insurance?
• Will I have to travel to appointments, and if so, how often?
• What are the potential benefits and risks of participating in this particular trial?
• Who will be in charge of my cancer care during the clinical trial?
• Will I have to undergo different procedures or take different medicines during the trial?