What is a clinical trial? Are they safe for cancer patients? Who can participate, and how does the process work?

Every advancement in cancer treatment begins its pathway to the patient in a laboratory. Researchers make observations and test their results for years before patients can participate in a clinical trial or study. Clinical trials are bridges that allow novel discoveries and therapies to reach patients and improve cancer treatment.

There are a variety of types of cancer clinical trials, including trials that focus on identifying safe and effective doses of approved medications, and trials that compare new therapies to an existing approach. The USC Norris Comprehensive Cancer Center offers a variety of clinical trials for patients with all types and in all stages of cancer.

Helping the cancer community

Clinical trials often are the only way to answer very important scientific questions that can affect the medical care, treatment guidelines and health of both current and future cancer patients. Clinical trial participants provide enormous contributions to advances in biomedical research and ultimately to the types and manners of medical care provided to the public.

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How do I know if I am a candidate?

Every cancer patient is a potential candidate for a clinical trial. “Trials are not only for patients who have no standard options available or have run out of options,” says says Anthony El-Khoueiry, MD, associate professor of clinical medicine at the Keck School of Medicine of USC, phase I program director and chair of the Clinical Investigations Support Office at the USC Norris Comprehensive Cancer Center.

There is a broad range of trial options that are designed to address different needs. A few examples include:

  • A trial may test the ability of a new drug to improve the odds of cure after cancer surgery.
  • Another trial may test the addition of a new drug to standard of care to see if it can make the existing standard therapy work better or longer.
  • A brand new drug may be tested in a trial to see if it is safe and determine the right dose in patients.

Current active clinical trials at USC Norris are testing important concepts, such as stimulating the immune system to fight the cancer or personalizing the treatment based on specific genetic changes in the tumor.

What should I know before volunteering?

Clinical trials have several levels of oversight to ensure patient safety. Every clinical trial in the U.S. is required to be reviewed and approved by an Institutional Review Board (IRB) — an independent committee of physicians, statisticians, community advocates and others who ensure a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that approves and periodically reviews the research.

Before enrolling in a clinical trial, a participant reviews what will happen in the trial, including possible side effects or risks, with the trial staff or investigators.

Patients should look at their participation in the trial as a partnership between themselves and the physician, with the doctor as a resource for information about the background of the study or its design.

By Melissa Masatani