Clinical Trials in Cancer

A Partnership Strengthened by Time: UCSF and ZSFG

The partnership between UC San Francisco and Zuckerberg San Francisco General Hospital and Trauma Center started in 1873. We work together on clinical care, research, and education. UCSF providers and researchers lead important studies and have earned major awards, including Nobel Prizes and National Medals of Science, for continuing to make improvements in health for patients from all communities.

Learning from the Past to Build Equity in Research

UCSF and ZSFG continue to make changes and study ways to address equity and anti-discrimination for research. It is important to acknowledge and learn from the inequities of the past to reach equity goals.

1700-1960s: Instances of segregation, exclusion, and unethical experiments in science, particularly with marginalized communities of color, low-income populations and other underrepresented groups.
1970-1990s: Start of Oversight and Inclusion. New laws and rules were created to make research safer and fairer with the National Research Act and Review Boards (IRB) checking studies to be sure they are following ethical/inclusivity requirements.
2020-Now: Ongoing study of potential inequities. Focusing on transparency, accountability, and trust-building with communities, especially those historically harmed by research.

What is Clinical Research?

Clinical research is the study of health and illness in people. It helps to find better ways to prevent, diagnose, and treat diseases, including cancer. These discoveries are only possible because volunteers participate in research studies.

Types of Clinical Research?

Clinical Trials: Most common type. Tests new treatments, devices, surgeries, or lifestyle changes (like diet or exercise) to see if they are safe and work well.
Observational Studies: Researchers watch and collect information without adding a new intervention. They look for patterns between health, habits, and environments.

Is it Safe? How Clinical Trials are Monitored for Safety

Institutional Review Boards (IRBs)

Before a clinical trial can begin, the IRB checks to make sure it is safe, fair, well-designed, and legal. They can change or stop a study if needed to protect participants. IRB ensures clinical trials do not involve unneeded risks and includes a safety plan for patients.

Data and Safety Monitoring Boards (DSMBs)

Some trials (especially Phase 3) use DSMBs to watch how the study is going. They make sure it stays safe and review if the treatment is working.

Office of Human Research Protections (OHRP)

Making sure participants are protected and that researchers follow important rules about consent and safety.

Food and Drug Administration (FDA)

Approves new drugs and treatments, making sure they work, are safe, and the benefits are greater than the risks.

The Four Phases of Clinical Trials:

You may see the word “Phase” used to describe a clinical trial. Phases are steps that a new treatment must go through to prove it is safe and effective before it can be approved for public use. Each phase has a different purpose and is designed to answer specific questions:

Phase 1: Is it safe?

Tests a new treatment on a small group of people (20-80) to check for safety and find the right dosage.

Phase 2: Does it work?

Involves a larger group (100-300) to see if the treatment helps and continues to monitor safety.

Phase 3: Is it better than usual care?

Tests the treatment on a large group of people (hundreds to a few thousand) to confirm it works, compares it to other treatments, and collects safety information. After Phase 3 shows that a treatment works and is safe, the Food and Drug Administration (FDA) reviews it for approval.

Phase 4: What else can happen (long term)?

After FDA approval and treatment is being used, continue to see how safe and effective it remains over time.