About the Phase 1 Clinical Trials Program
Huntsman Cancer Institute at the University of Utah is a national leader in cancer discovery and innovation. Phase 1 clinical trials are the foundation of progress in oncology, transforming scientific breakthroughs into safe and effective therapies. Nearly every cancer treatment in use today began in a clinical trial. As the largest Phase 1 clinical trials program in the Mountain West, Huntsman Cancer Institute delivers cutting-edge care through a rigorous, patient-centered approach that advances science while prioritizing safety and outcomes.
Making Innovation Accessible
The Phase 1 clinical trials program increases patients’ access to novel research by bringing it closer to their homes. Distance should never stand between you and the latest medical breakthroughs. As the only NCI-designated Comprehensive Cancer Center in the Mountain West, we have reimagined cancer care. We serve patients throughout Utah, Nevada, Wyoming, Idaho, Montana, and beyond, bringing groundbreaking cancer treatments closer to you.
Expertise in First-in-Human Clinical Trials
Early-phase (Phase 1 and Phase 2) clinical trials offer patients access to some of the most advanced cancer therapies available anywhere in the world. Our multidisciplinary team has deep expertise in first-in-human studies, enabling the safe and precise evaluation of novel agents. Through innovation and discovery, we are redefining what is possible in cancer treatment.
A Network of Excellence
In addition to being a world-class comprehensive cancer center, we are also an integral part of University of Utah Health, a robust health care system. Cancer treatment requires a team approach, and our patients benefit from collaboration between oncologists, surgeons, researchers, and more. We tailor your care to address your unique needs—treating you, not just the cancer.
From the Lab to the Bedside
The Phase 1 clinical trials program brings scientific discoveries to our patients through a dynamic partnership between doctors and scientists. Our researchers study how to best diagnose, treat, and cure cancer in labs right here on our campus in Salt Lake City. These discoveries benefit patients by becoming new therapies and cancer treatments. Our cancer experts are committed to offering patients the latest advancements in cancer care.
Training the Next Generation
We take pride in being a teaching institution, serving as a training ground for the next generation of doctors and researchers. Our dedication to education ensures that innovation continues on the path to a future free from cancer.
Frequently Asked Questions
What is a Phase 1 clinical trial?
Phase 1 clinical trials are the first tests that include people to assess new drugs or treatments. The purpose of Phase 1 trials is to determine a safe dose of the treatment. Phase 1 trials also help to see how the drug affects the body. These studies may include newly developed drugs or new combinations of existing therapies.
Phase 1 trials typically include a small number of people with different types of cancer. Some patients might benefit from the new therapy. The main goal of the trial is to monitor patients for serious side effects. Inactive treatments known as placebos are rarely used in Phase 1 trials.
What is a Phase 2 clinical trial?
Once Phase 1 trials establish a safe dose of the new drug, a Phase 2 clinical trial is done to confirm its safety in larger groups of people. The primary goal for Phase 2 trials is to determine the therapy’s efficacy. Blood and tissue samples may be collected to help determine how well the cancer responds to the treatment.
Are Phase 1 clinical trials safe?
Phase 1 trials include a small number of patients at a time. Our team monitors each participant very closely to make sure the doses they receive are safe. Patients in Phase 1 trials are seen more often than patients receiving standard treatments, and we conduct tests to evaluate the safety of the treatment. The process is carefully monitored to ensure patient safety.
How long are patients enrolled in Phase 1 clinical trials?
Phase 1 trials typically last about two years. All phases of clinical trials are voluntary. Patients can stay in the clinical trial as long as they benefit and tolerate the therapy, but they can leave the trial at any time.
Available Clinical Trials
Patients with a variety of cancer types can take part in our Phase 1 program. Learn more about open clinical trials and eligibility.
Find a Phase 1 Clinical Trials Doctor
Your care is tailored to you and includes a team of medical professionals in addition to your oncologist. From compassionate nurses to skilled clinical trial coordinators, your doctor works hand in hand with many dedicated experts to provide support during your treatment.
Leadership
Naren Epperla, MD, MS, FACP
Rachel Kingsford, MS, CCRP
David Samuel, BA CCRP
Clinical Research Nurses
Clinical research nurses (CRN) specialize in oncology and have analytical skills and expertise for the clinical trials they are working on. They explain the details about the clinical trial to the patients. CRNs work closely with the treating physician, assisting and providing care for their patients during visits in clinic. CRNs also work closely with the study team to share important information about how patients respond to the study drug and the care they are receiving.
Phase 1 Clinical Research Coordinators
Clinical research coordinators (CRC) work closely with the principal investigator (PI), the expert who is conducting the clinical trial. The CRC is a liaison between clinical staff and study staff. They ensure everyone is properly trained on the protocol for the clinical trial. CRCs screen patients to determine who might be eligible to participate and collect pertinent safety information while the patient is on trial. They have administrative duties and work closely with the sponsor to ensure proper documentation is obtained to remain complaint.
Research Data Coordinators
Research data coordinators (RDC) oversee the clinical data obtained for trials. RDCs have thorough knowledge of the clinical trial’s protocols and regulatory rules such as patient treatment procedures, reactions to therapy, lab procedures, and results. They specialize in information gathering and share findings with study sponsors, PIs, and regulatory authorities.
Clinical Trials Navigator
Navigators assist the patient by explaining complex clinical trial protocols and health care systems. This role is focused on helping clinical trial patients by establishing and maintaining communication between their health care teams. They can work out eligibility concerns and offer essential information to patients when they face important choices about their treatment and care.
Clinical Research Program Manager
The clinical research program manager oversees the clinical research study team. They work closely with all PIs, sub-investigators, and study staff to ensure the protocols are being followed. Program managers also focus on maintaining patient safety, providing quality care, collecting needed documents, and communicating with other program managers and leadership.