At UC San Diego Health, you have access to innovative, investigational treatments and therapies. This is because our physicians and their UC San Diego School of Medicine colleagues are researchers. They are continuously making discoveries to improve your health and quality of life.
Do you have a disease or condition that has not been successfully treated or managed by standard treatment approaches? You may be a candidate for participation in a clinical trial.
What Is a Clinical Trial?
Clinical trials are research studies that involve people. They are the final step in a long process that begins with research in a lab and animal testing. Many treatments used today are the result of past clinical trials. Clinical trials look at new ways to:
- Treat conditions and diseases
- Find and diagnose disease
- Prevent disease
- Manage symptoms of a disease or its treatment
Types of Clinical Trials at UC San Diego Health
We offer many types of clinical trials. They may test novel drugs or novel combinations of drugs. They may also test surgical techniques, medical devices or new ways to use existing treatments or devices.
Most clinical trials are conducted in phases that build on each other:
- Phase I trials: These evaluate how a new drug should be given (for example, orally or injected), how often, and what dose is safe.
- Phase II trials: A phase II trial continues to test the drug's safety and begins to test how well the new drug works.
- Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard of care. Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics and cancer centers nationwide.
Why Participate in a Clinical Trial?
Clinical trials give you early access to new drugs or treatments. You receive care and attention from a research team that includes physicians, specialists and other health professionals, often at no cost. By taking part in a clinical trial, you also advance medicine for others. New, better treatments would not be possible without people like you!
What to Expect
Clinical trials take place in the same setting where standard patient care occurs. Your regular doctors, nurses, social workers and other health professionals are often part of your care team.
As a clinical trial's participant, you may have more tests and office visits than usual. You may also have other responsibilities, such as keeping a log or filling out forms about your health. You will have a clinical research study coordinator to help you. Your study coordinator will schedule your appointments, make sure your labs are performed and be on call to answer your questions.
Safety and Informed Consent
Your safety is the top priority for any clinical trial. To protect your safety, the federal government regulates most clinical research. All researchers prepare plans of action for their studies, called a “protocol.” The protocol outlines how many people will take part in the study, what medical tests they will receive and how often. It also includes the treatment plan.
Before a study can proceed, the University of California, San Diego Institutional Review Board must review and approve the protocol. This board includes doctors, ethicists and members of the community. Together, they ensure that the trial is safe and ethical.
Understanding Informed Consent
Before you agree to participate in any clinical trial, you will receive information about key aspects of the study. This is the beginning of a formal process called “informed consent.”
Your doctor or study coordinator will discuss the study with you. A written consent form will then be available for you to take home to read and discuss with your family and friends. The consent form will include:
- The study approach
- The intervention (such as a new drug or treatment) given in the trial
- The possible risks and benefits
- The tests you may have
If you decide to take part in a study, you will sign a consent form, but this is not the end of the informed consent process.
You can change your mind and leave the study whenever you want. It will not affect your access to other treatments.
Your research team has a duty to keep you informed, help you understand the information, and answer your questions.
ResearchMatch: Everyone benefits when you volunteer
UC San Diego participates in
ResearchMatch. Anyone can join. ResearchMatch can help "match" you with any type of research study, ranging from surveys to clinical trials. You decide which ones interest you.