Clinical Trials

Clinical trials are research studies that test new therapeutic treatments or procedures. The goal of a clinical trial is to find better ways to prevent, diagnose and treat diseases. Experts carefully design and conduct clinical trials to advance medical care and improve outcomes for our patients. 

Clinical trials help us test whether new treatments are safe and effective. They also help us understand how new treatments compare to existing treatments. We use clinical trials to assess new: 

• Medical devices 
• Medications to treat or prevent diseases 
• Methods to diagnose and screen for diseases
• Procedures 

Many of the standard treatments we use today started as clinical trials. These studies are a crucial tool for developing new and better approaches to medical care.

Besides advancing medical care, clinical trials can offer patients many benefits. You may benefit from: 

• Feelings of control as you take an active role in treating your illness
• First-line access to treatments not available outside of clinical trials
• Satisfaction from knowing you’re helping improve medical care for future generations

Clinical trial treatments can cause side effects or other health risks. Because clinical trials research new treatments, we don’t always know the potential risks ahead of time. 

Your doctor or nurse will explain the potential risks and benefits of a trial treatment. You will sign an informed consent form that explains these risks. Ask your doctor or nurse if any parts of the form are unclear. Even if you sign the form, you can leave the trial at any time and receive other treatments. 

Eligibility for clinical trials varies. It may depend on factors such as: 

• Specific trial criteria set by the researchers 
• The severity of your diagnosis 
• Your overall health 

Your doctor or the research coordinator will help you determine if a clinical trial is right for you. 

Some clinical trials also involve “healthy volunteers.” Being a healthy volunteer means you have no significant health problems. You voluntarily participate in research to test a new drug, device or treatment. Healthy volunteers are essential for helping us compare how new techniques affect healthy patients versus sick patients. It’s a way to define what’s “normal.” View trials actively recruiting healthy volunteers.

Currently, racial and ethnic minority groups make up less than 10% of all participants in clinical trials. This statistic is concerning because having diverse groups of people participating in clinical trials helps ensure new treatments work for everyone.

A person’s response to a disease or medication depends on multiple factors, including their: 

• Ethnicity
• Genes
• Lifestyle
• Sex assigned at birth 
• Social and economic background 

Clinical trials follow strict rules that ensure every participant is treated equally, regardless of race, ethnicity, gender or age. At UCLA Health, we are committed to helping increase diversity in clinical trials so that we improve the lives of all our community members. 

Researchers divide clinical trials into four phases: 

• Phase 1: Researchers test a new drug or treatment for the first time. They give the treatment to a small group of people to study its safety, side effects and dosage. 
• Phase 2: Researchers test the drug or treatment in a larger group of people. This phase studies the treatment’s safety and effectiveness. 
• Phase 3: An even larger group of people receive the drug or treatment. This phase tests the treatment’s effectiveness and side effects again. Researchers also compare the drug or treatment to existing treatments. 
• Phase 4: These studies occur after the drug or treatment has been approved by the U.S. Food and Drug Administration (FDA) and is available to the public. Researchers collect information on how the treatment affects different groups and whether any problems arise with long-term use. 

A randomized study places participants into different groups by chance. These groups include the: 

• Control group: People who receive standard treatments or a placebo (harmless treatment with no effects) instead of the trial treatment
• Treatment group: People who receive the trial treatment 

You don’t get to pick which group you’re in, and neither do the researchers. A computer places you in a group at random, like flipping a coin to make a decision. This process helps researchers avoid bias, or unfairness, in who gets put into a certain group.

In a blinded study, you don’t know whether you’re getting the trial treatment or a placebo. There are two types of blinded studies: 

• Single-blind study: The study participants don’t know which treatment they’re getting, but the researchers do. 
• Double-blind study: Neither the study participants nor the researchers know who is getting the placebo and who is getting the trial treatment. Only the pharmacist involved in the trial knows. 

It is possible for you to find out which group you’re in if it’s medically necessary. You may or may not receive the results of the study. You can ask the research team if you’re interested. 

You may contact our clinical trial navigators to find out about trials that may be right for you. Call 855-731-6040 or request a call back.

You may need to complete a pre-screening form to find out if you qualify for the trial. You may also complete our matching questionnaire to find out about relevant clinical trials.

It’s important to ask questions if you’re considering a clinical trial, such as:  

• What is the purpose of this study? 
• What kinds of tests and treatments will this study involve? 
• How long will the study last? Will I need long-term follow-up care? 
• How might this study affect my daily life? 
• What are my other treatment options if I don’t enroll in the study? 
• What are the risks, benefits and potential side effects of this study? 
• Will I have any treatment costs?

Informed consent is the process of giving you all the important details of a clinical trial before you decide to participate. Your doctor or nurse will help you understand: 

• The hoped-for benefits of the trial 
• The potential risks of the trial 
• What to expect during the trial 
• Your rights as a trial participant

You sign a consent form if you agree to participate in the study. You don’t have to agree to participate or sign the form. Even after you sign the form, you can choose to leave the study at any time. 

Before you enroll in a clinical trial, our research staff will explain the trial and answer your questions. Before and throughout the trial, you will: 

• Learn about the study’s purpose, including the potential benefits and risks 
• Discuss what the treatment entails 
• Review your rights and protections as a clinical trial participant 
• Get extra support and monitoring to ensure your safety 

Participating in a clinical trial is voluntary. You can change your mind and withdraw at any time throughout the study. Regardless of whether you participate in or withdraw from a trial, we provide you with advanced, effective treatment. 

Researchers follow rules to ensure you receive quality care and are always treated with respect. They have special training to protect your privacy and information. 

Participating in a clinical trial will not: 

• Alter the quality of care you receive 
• Change your relationship with your doctor
• Deny you care at your medical institution 

Participating in a study is always up to you, and you can decide to leave a trial at any time. You should talk with your doctor about any concerns before leaving the study. Your doctor will explain whether there are any medical risks of opting out. 

Only the research staff will be able to see your information from a clinical trial. These staff have special training to protect your privacy. 

Before you join the study, you may sign a consent form allowing researchers to store your information in a secure database. The form will list the people who can see this database. Researchers keep information that identifies you separate from other information. Identifying information has extra levels of protection to keep you safe. 

Sometimes researchers share study details with other researchers. If they do, they won’t share any information that could identify you. 

You always have a right to: 

• Ask for information in the language of your choice, including through an interpreter 
• Decide not to participate in a study 
• Fully understand your diagnosis and treatment plan 
• Leave a study at any time 
• Receive safe and respectful care

You will never be treated differently because of your ethnicity, sex or age. You can receive additional assistance for special needs. These are your rights whether or not you participate in the study.