In the battle against devastating diseases such as cancer, stroke and heart disease, a major effort is the development and testing of new tactics: surgeries, drugs, radiation therapies, preventive therapies and more that might lead to a cure. Clinical trials — help us discover new and innovative ways to treat disease. For example, a trial may test the effectiveness of blood pressure medication or whether a certain drug can lower cholesterol.
Keck School of Medicine of USC faculty members lead and participate in many of the nation’s largest multi-center clinical trials, as well as in many unique smaller trials. Although participating in a clinical trial is not the right choice for everyone, many patients receiving care in one of USC’s affiliated medical facilities have chosen to become involved in clinical trials.
Hundreds of clinical trials take place on the USC Health Sciences Campus each year, giving select patients access to therapies not available elsewhere. If you are interested in participating in one of our clinical trials, please visit the following websites for more information:
Most research studies have certain requirements that must be met in order for a subject to participate. These requirements are designed to ensure the safety of the subjects and the usefulness of the research. Some studies have broad requirements such as being over 18 years old. Other studies are specific to illness, age, or lifestyle.
Research may involve different types of risk. A study that asks you to fill out a survey has only minor risks, such as questions that may make you uneasy. For other studies, such as taking an experimental drug, the risks can be much greater (e.g. having a bad reaction to the drug). The research team is required to explain to you any expected risks of being in the study before you decide whether or not to participate.
Not everyone who participates in a clinical trial will benefit personally. Sometimes, your participation in the clinical trial will be of benefit to society by helping researchers to learn more about a certain disease or condition. However, in studies using an experimental drug or device, there is a chance that you may benefit but this cannot be guaranteed.
Typically, a medical doctor leads a clinical trial aided by nurses and other study personnel. The person in charge of a study is called a Principal Investigator (PI). The PI is responsible for the overall conduct of the clinical trial. The PI is also responsible for assuring the safety of the participants.
Principal Investigators often rely on a research team to assist them in their study. The research team can be made up of research assistants, research nurses, data coordinators, statisticians, and other people with special skills needed for the study.
An IRB is a committee of scientists and non-scientists who review projects submitted by researchers. The University of Southern California has four IRBs; one on the University Park Campus, and three on the Health Sciences Campus. The IRB’s purpose is to protect the rights and welfare of the research subjects in a study.
Like your medical record, the information in your research record will be confidential. Information will be given only to the researchers who carry out the study or to those who make sure the study is safe and carried out the way it was planned.
Children, pregnant women, and prisoners can all be participants in research studies, but are considered potentially “vulnerable populations.” There are special rules to protect participants who fall into one of these groups.
Research studies can involve a wide variety of procedures, ranging from filling out surveys and questionnaires to taking experimental medicines or using experimental devices. Some research studies last only a few minutes, while others last for several years. The research team will describe to you all of the procedures that you will be asked to undergo before you agree to be in the study.
Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to volunteer. Your agreement to volunteer should be based upon a clear understanding of what will take place in the study and how it might affect you. The consent includes details about the study, tests, or procedures you may receive, the benefits and risks that could result, alternatives available should you decide not to participate, and your rights as a research volunteer.
Before you decide to volunteer for a clinical trial, you need to know as much as possible about it. If there are any issues that concern you, be sure to ask questions. You have every right to get answers to all you ask before deciding to participate in a trial. The following booklet (in English and Spanish) can help you prepare your discussion about whether a clinical trial is right for you.
Institutional Review Board
Darcy Spicer, M.D., Chair
Sandra Jean, CIP, IRB Director
General Hospital, Suite 4700
1200 North State Street Los Angeles, CA 90033
Tel: (323)-223-2340 Fax: (323)-224-8389
E-mail: email@example.com http://oprs.usc.edu/hsirb/
Institutional Review Board
Richard John, Ph.D., Chair
Kristin J. Craun, MPH, CIP, Director
Credit Union Building (CUB), Suite 301
3720 S. Flower Street
Los Angeles, CA 90089
Tel: (213)-821-5272 Fax: (213)-821-5276
E-mail: firstname.lastname@example.org http://oprs.usc.edu/upirb/
For copies of the “Should I participate in research” brochure, contact email@example.com
Test new treatments, new drugs, innovative surgical procedures or radiation therapy, new combinations of treatments, or new methods such as gene therapy.
Test new approaches, medicines, vitamins, minerals, or other supplements that doctors believe may prevent or lower risk of illness.
Study designed to evaluate and improve methods for disease diagnosis or disease progression.
In an observational study, investigators assess health or behavioral outcomes in groups of participants without assigning them to a specific study group. Participants continue to receive routine care.
What are the benefits of participating in a clinical trial?
Aggressive Treatment – For patients with advanced disease, clinical trials offer some of the most aggressive options for treatment.
Early Access to Treatments – When an agent being tested in a clinical trial proves superior, patients benefit by having received a treatment they wouldn’t have been able to receive otherwise.
Close Monitoring – Because clinical trial treatments are experimental, the patient is closely observed, both by the physician and a research nurse. Each trial has a “protocol” that specifies how and when patients are seen, given their medication and monitored with blood and other diagnostic tests.
Advancing Medicine -Although the main motivation to enter a clinical trial is the possibility of obtaining the best treatment, participants are also advancing the war on cancer and other diseases.
What are the phases of clinical trials?
Trial phases categorize clinical trials by study goal, stage in drug development and number of subjects.
Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug’s most frequent and serious adverse events are and, often, how the drug is metabolized and excreted.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). Safety continues to be evaluated, and short-term adverse events are studied.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages or by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing. These studies gather additional information about a drug’s safety, efficacy, or optimal use.
How are clinical trials supervised?
Researchers who conduct clinical trials are required to have a plan that describes how the trial will be conducted. Various people will be responsible for seeing that the study will be conducted in a safe manner according to the research plan. This can include the research team which may include your doctor, a nurse or coordinator, institution, and agency or company sponsoring the study. Clinical trials with experimental drugs or medical devices can also be inspected by the Food and Drug Administration (FDA). The FDA has strict guidelines and regulations that help ensure the safety of clinical trials.
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