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. Other studies have a more focused requirement such as having a certain disease.
NO! Participating in a research study is voluntary. A subject can drop out of a study at any time. Refusing to participate in a study will not result in a penalty or loss of any benefits to which you are entitled.
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 the foreseeable risks of being in the study before you decide whether or not to participate.
Not everyone who participates in a research study will benefit personally. Sometimes, your participation in the research study will be of benefit to society by helping researchers to learn more about a certain disease or condition. In some studies, however, you may personally benefit from medication that aids in your recovery or from any needed counseling.
The Principal Investigator (PI) leads the research study. The PI is responsible for the overall conduct of the research study. The PI is also responsible for assuring the safety of the subjects. PIs are often faculty, physicians, or students.
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 research study 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 process begins when the research staff explains the facts about the research study to you. The research staff will assist you with the “informed consent form” that goes over these facts so you can decide whether or not you want to take part in the study. These facts include details about the study, tests, or procedures you may receive, the benefits and risks that could result, alternatives available should you decided not to participate, and your rights as a research volunteer.
Before you decide to volunteer for a research study, you need to know as much as possible about it. If there are any issues that concern you, be sure to ask questions. The following is a list of important questions. Not every question applies to every study, but you have every right for answers to all you ask.
Will I benefit from this study?
Who is doing this study and what question might it answer?
Will this research help me to understand my condition? If so, how?
Will I miss out on any “normal care” by participating in this study?
What tests or procedures will be done?
What alternatives are available if I decide not to participate in the study?
Is it possible that I will receive only a placebo (inactive substance)?
What could happen to me, good or bad, if I take part in the study?
How long will the study last?
What will happen to specimens I give?
Who has reviewed/approved this study?
If I have a condition, could it get worse during the study?
Will I be charged anything or paid anything to be in this study?
If I decide to participate in this study, how will it affect my daily life?
What will happen to me at the end of the study?
Will I be told the results of the study?
Who will find out that I am taking part in this study?
How do I end my participation in this study if I change my mind?
Whom do I contact for questions and information about the study?
USC Complaints, Concerns, or Reports of Violations Website
This website provides info on how to report a complaint, concern, or violation (anonymously if you prefer). You can also contact the offices listed below.
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
The majority of clinical trials are “therapeutic” — offering new treatments to those who have advanced diseases such as multiple sclerosis or heart disease. Some are “adjuvant,” such as those testing hormones to prevent recurrence of breast cancer. “Prevention” trials test agents that may help reduce the likelihood of developing diseases for those at high risk. In “translational” trials researchers examine a patient’s own genes to determine what genetic makeup responds best to particular treatments.
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?
Clinical trials are divided into four “phases.” Which trial is offered to an individual patient depends upon the stage of their disease, prior treatment and the specific eligibility criteria of the trial.
A Phase I trial is a new treatment that has not been tested, and researchers are looking for the best way to administer the treatment and how much can be given safely. Phase I trials are usually offered only to patients with advanced disease who would not be helped by other known treatments. Some patients are helped by these treatments, although in this early stage physicians don’t really know if the treatment will be effective.
A Phase II trial takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn’t usually preclude the patient from getting the standard treatment after they’ve received the investigational agent. At best they are allowed to get a new drug they wouldn’t be able to get otherwise that may turn out to be better for their disease.
If a treatment has shown activity against a particular disease, it is moved up to Phase III, where it is either added to existing treatment or compared to the standard treatment.
Phase IV refines the treatment to become part of standard care.
How are clinical trials monitored?
Clinical trials are rigorously regulated. As with any new medication or surgical procedure, treatments are first studied thoroughly in the laboratory. Many represent simply a new approach, such as dosing or schedule changes, or addition to existing standard treatments, such as a medication that may enhance the effectiveness of a standard drug or reduce a toxic side effect. If basic research establishes that a new method or chemical seems likely to succeed safely and effectively in patients, it can be submitted for approval for a clinical trial.
Not only must the submission meet regulatory guidelines established by organizations such as the National Cancer Institute (NCI) and the Food and Drug Administration, but it must be first reviewed for scientific merit by the Hospital Clinical Investigations Committees. It is then submitted to the USC Health Sciences Institutional Review Board (IRB), a panel of 36 scientists, researchers and others in the community who additionally approve the proposal for safety and ethical issues.
Aside from reviewing the science and safety and efficacy, the IRB gives serious consideration to the proposed trial’s “informed consent” — the document that physicians will give to patients explaining the trial and its potential risks.
Once approved, clinical trials are monitored through the hospitals’ Clinical Investigations Support Offices, where research nurses follow patients closely and where data managers track their progress.
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