For many patients with cancer, participation in a clinical trial is an important part of their treatment. In Orange County, City of Hope is transforming cancer care by expanding access to leading-edge research and groundbreaking clinical trials. These trials evaluate the safety and effectiveness of new treatments, paving the way for advancements years before they become standard care.
What approaches are driving innovation in cancer research and treatment, and what types of trials are being conducted at City of Hope Orange County?
Clinical trials 101
Clinical trials are carefully designed research studies that evaluate the safety and effectiveness of new medical treatments. Many physicians at City of Hope Orange County have open clinical trials for cancer treatments they have designed.
"Our research team is committed to unlocking new possibilities in cancer treatment,” said Stephanie Casal, the executive director of clinical research at City of Hope Orange County. “We are poised to expand our impact on patients' lives and push the boundaries of medical knowledge.”
There are typically four phases that make up a clinical trial.
- Phase 0: While not always included, a small number of participants may be involved in gathering initial data. This phase includes initial data on whether the new drug is working as expected.
- Phase 1: This phase typically involves 15-30 people and focuses on assessing the treatment's safety and dosage. More than 74% of open trials at City of Hope are in this stage.
- Phase 2: A larger group of participants is involved further to evaluate the treatment's effectiveness and side effects.
- Phase 3: This is the final stage before potential approval. It involves hundreds to thousands of participants to confirm the treatment's benefits, monitor side effects, and compare it to existing treatments. This phase helps researchers gather essential data to determine whether a treatment is safe and effective for widespread use.
- Phase 4: In this phase, studies look at drugs that have already been approved by the U.S. Food and Drug Administration.
Using biomarkers as the signposts in clinical trials
Biomarkers are biological indicators that can be measured and used to assess various aspects of health and disease in living organisms, including humans. These indicators can be found in different biological materials like blood, urine, tissues, or even genetic information.
Biomarkers provide valuable information about the physiological processes occurring within the body. They can signal the presence of a particular disease, track its progression, and monitor the response to treatments. In essence, biomarkers act as "signposts" that help researchers, doctors, and scientists understand the health status of an individual, identify potential diseases, and develop personalized approaches to health care.
Due to their significance in diagnosing and managing diseases, biomarkers play a critical role in medical research, clinical trials, and improving patient outcomes. They pave the way for early detection and targeted treatments, leading to more effective and efficient health care strategies.
Matching drugs to patients based on molecular features
Precision medicine, also known as personalized medicine, revolutionizes disease prevention and treatment by considering individual variations in genes, environments, and lifestyles. When it comes to cancer, this leading-edge approach utilizes precise data about a person's tumor to aid in diagnosis, treatment planning, monitoring treatment effectiveness, and predicting outcomes.
The Precision Medicine Initiative (PMI) is a groundbreaking effort by the National Institutes of Health (NIH) to accelerate biomedical research and provide clinicians with new tools for personalized treatment approaches. Precision oncology, the initial focus of the initiative, utilizes genetic insights to identify effective therapies for cancer treatment. With the potential to revolutionize healthcare practices, the PMI aims to expand this individualized approach to other disease areas, heralding a new era of personalized medicine.
What types of research is City of Hope Orange County conducting?
City of Hope Orange County is expanding its portfolio, conducting research at its regional network clinics and in a specially designated Clinical Research Unit (CRU) for Phase 1 and high-complexity trials. Located at City of Hope Orange County Lennar Foundation Cancer Center — the most advanced comprehensive cancer center in Orange County — the CRU offers a separate area for infusion chairs and research beds specifically designed to allow monitoring of patients in a controlled environment for each trial.
The diverse range of trials include City of Hope-sponsored trials that feature new treatments:
- Developed by City of Hope physician scientists in a bench-to-bedside model. Findings in the lab are sped to the patient, and effects on the patient are sped to the lab for testing.
- Sponsored by pharmaceutical companies, trials involving industry investigational drugs (IIDs), and cooperative group trials.
This extensive research effort highlights City of Hope Orange County’s commitment to exploring new treatment options and providing patients with cutting-edge therapies.
A legacy of breakthrough cancer research
One of the largest cancer research and treatment organizations in the United States, City of Hope offers more than 800 clinical trials each year, more cancer-focused clinical trials than anywhere else in California.
Many trials that start at City of Hope have gone on to make a global impact. Numerous breakthrough cancer drugs, such as Herceptin, Erbitux, Rituxan, and Avastin, are used by more than 100 million people globally and are based on technologies developed at City of Hope. These pioneering treatments underscore City of Hope’s role as a global leader in cancer research.
First in research. First in treatment. First in survival. When it comes to cancer, it’s Hope First. Call (888) 333-HOPE (4673).