Clinical Trials Overview

Patient care and research specialists at the University of California, San Francisco (UCSF) are committed to finding new ways to prevent and treat disease in people, and these efforts involve a form of clinical research called clinical trials.

A clinical trial directly involves a person or group of people. After a proposed treatment, drug therapy or device is found to be helpful and safe in animals in laboratories, it must also prove to be safe and effective in humans. This evaluation period is known as a clinical trial. A clinical trial also can study human behavior.

As a leading health sciences university, UCSF is actively involved in about 1,000 clinical trials. All trials are conducted in coordination with UCSF Medical Center, which serves as UCSF’s academic medical center and is ranked as one of the nation's top 10 hospitals by US News & World Report

Peter R. Carroll, MD, MPH, chair of the Department of Urology, talks with patient Richard Crisman in a clinic at UCSF.

Finding a Clinical Trial

To review a list of clinical trials available at UCSF, see “Find a Clinical Trial.” For a summary of clinical trials throughout the United States and the world that is maintained by the National Institutes of Health (NIH), see “NIH Clinical Trials.”

People who participate in clinical trials do so voluntarily and are known as research volunteers. Some trials are for adults only, while others are open to children, who may participate if permission is provided by an appropriate parent or guardian. The length of a clinical trial varies according to the questions it is trying to answer, and ranges from a few hours to several years.

While clinical trials are considered the fastest way to determine if a proposed intervention is safe and effective, they include both potential benefits and risks. A trial participant has the chance to receive a potentially promising treatment that is not available to the general public and to receive care at the nation’s top academic medical centers and research institutes.

Laura Esserman, MD, MBA

Laura Esserman, MD, MBA

However, those participating in clinical trials face the chance that their disease or condition will not improve with the experimental treatment, and they could experience adverse side effects, among other possible drawbacks.

Empowering Patients

What is most important for patients is knowledge about and access to clinical trials, so they have the opportunity to participate if they choose, emphasizes Laura Esserman, MD, MBA, director of the UCSF Carol Franc Buck Breast Care Center.

In 2009, the Buck Center joined with QuantumLeap Healthcare Collaborative and the Safeway Foundation in launching the nation’s first clinical trial matching service dedicated exclusively to breast cancer:

“Our aim with this site is to empower patients with information about the best treatment options available today and to spur new discoveries that will inform breast cancer care in the future,” Esserman says. “Most women who get a breast cancer diagnosis today will survive – and every advance has come as a result of a clinical trial.”

Rules on Approval and Adherence

The details of a clinical trial, including all tests and procedures used in the trial, are outlined in a research plan, usually called a protocol. Before a clinical trial can begin, the protocol must be approved by an institutional review board. At UCSF, this group is called the Committee on Human Research (CHR).

After a clinical trial is approved by the CHR, a UCSF team of researchers, clinicians and other patient care specialists oversees the trial and all interactions with the research volunteers. This team follows strict rules set forth by the US Food and Drug Administration and other government agencies regarding clinical trial processes. The rules ensure that people who participate in clinical trials are treated as safely as possible.

A clinical trial is paid for by the organization that sponsors the research, which may be a drug or medical device company, as well as by private foundations, gifts to UCSF, faculty members on the trial team or the departments of the UCSF faculty members.

More Information

More information about clinical trials and participating in a trial at UCSF is available at Volunteers for Clinical Research at UCSF.