What are the benefits and risks of participating in a clinical trial?

Benefits to participants:

• Play an active role in their own health care.
• Gain access to new research treatments before they are widely available.
• Help others by contributing to medical research.

Risks to participants:

• There may be unpleasant, serious or even life-threatening side effects to experimental treatment- these will be described in the informed consent document.
• There is no guarantee that the experimental treatment may be effective for the participant.
• The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

What are side effects and adverse reactions?

• Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include a variety of physical problems such as headache or nausea. Experimental treatments must be evaluated for both immediate and long-term side effects.

What should people consider before participating in a trial?

People should feel well informed about the clinical trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

• What is the purpose of the study?
• Who is going to be in the study?
• Why do researchers believe the experimental treatment being tested may be effective?
• Has it been tested before?
• What kinds of tests and experimental treatments are involved?
• How do the possible risks, side effects, and benefits in the study compare with my current treatment?
• How might this trial affect my daily life?
• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the experimental treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow up care is part of this study?
• How will I know that the experimental treatment is working?
• Will results of the trials be provided to me?
• Who will be in charge of my care?

What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?

• Plan ahead and write down any questions you wish to ask. Ask a friend or relative to come along for support and to hear the responses to the questions. Bring a tape recorder to record the discussion to replay later. Every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that 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 initially approves and periodically reviews the research.

Can a participant leave a clinical trial after it has begun?

• Yes. A participant can leave a clinical trial at any time, for any reason.

What is a placebo?

• A placebo is an inactive pill, liquid or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment. Many oncology studies do not have placebo arms to the study as this would be unethical.

Meet Our Research Team

Our dedicated research team is experienced and committed to research. We, along with our Physician/Investigators, work compassionately with our patients to ensure they are educated about clinical trial participation and their treatment options.

• Arthur Loussararian, MD - Medical Director of Clinical Research
• Sonia Cummings, CCRC
• Emilie Fien, CRC
• Carrie Mirza, CCRC - Supervisor of Clinical Research

Information for Patients

Why participate in a Clinical Trial?

There are a variety of reasons for why participants get involved in a clinical trial or research study. For example, some patients volunteer to receive new treatments that are not yet available to the general population because of the potential benefits. Others choose to participate because they want to contribute to the advancement of medicine in order to benefit others with similar illnesses. Whatever the reason, volunteers participating in clinical research are the driving force behind the medical advances that improve the lives of millions of people.

Each clinical trial has specific criteria or guidelines that are used to identify appropriate participants-and ensure their safety. These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

What else do I need to know about clinical trials?

It's important that you have enough information to make a well-informed decision before participating in a clinical trial. To do this, we provide what's called an informed consent document that outlines all the information you need to know about the study. We'll go over the details of the study with you and want you to ask questions. You should only join a clinical trial if you feel you have enough information about the possible risks and benefits involved.

Joining a clinical trial is always voluntary and you may leave a study at any time.

How do I join a clinical trial?

If you are interested in learning how you might benefit from participating in a clinical trial, ask your doctor for more information or contact one of our certified clinical research coordinators at (949) 364-3612.

Information for Providers

As providers, we know you want to be informed about your patients. It is our goal to work in partnership with you to not only provide opportunities for your patients, but maintain their eligibility for participation while simultaneously caring for these individuals. Provided your patients elect to keep you informed as part of the consent process, we are glad to share their progress, any study related restrictions and any results received based on study related procedures. Likewise, we are available to answer questions both study and patient specific.

Ultimately we’d like for you to consider participation in a Clinical Trial as an option for your patients that might qualify. Participating in a study often requires more frequent follow up visits than standard of care affords. It’s been our experience that given the opportunity, we are able to help build healthy habits and compliance with patients that needs a little extra encouragement through regular and on-going interaction.

Information for Sponsors Regarding Our Clinical Trials Program

Mission Heritage Medical Group offers a complete and integrated approach to patient care. As part of that care team, we have a dedicated Clinical Trials & Research staff that is experienced in multiple healthcare indications and have successfully enrolled and retained study participants in both long and short term clinical trials. As part of a multi-specialty health system, we have a large population of patients that we not only treat on an on-going basis with, but also established physician/patient relationships that contribute to confidence in participation and compliance.

Within our facilities, we are able to meet the needs of many study-related procedural needs and diagnostic testing. Listed below are some of our many in-house resources available to provide study assessments.

• Clinical Lab
• Coumadin Clinic
• Nuclear Cardiology Diagnostics
• Nutrition Services
• Bone Density Center
• Sleep Center
• Vascular Department
• Vein Center

Our physicians are all on staff at Mission Hospital, located just 500 yards from our facility, and have engaged in Clinical Trials and Research there as well, with patients often completing trial participation/follow-up in the clinic setting.

Local IRB oversight is provided by St. Joseph Health (Insert hyperlink to their page) when trial involvement requires hospital based activities, but in most cases we are able to use a Central IRB identified by the study sponsor.

If you are a sponsor or CRO, we welcome your inquiries and the opportunity to work collaboratively on your upcoming projects. For more information about Clinical Trials & Research at Mission Heritage Medical Group, please call us at (949)364-3612.

How Can I Join A Trial?

If you are interested in learning more about clinical trial participation, or a study opportunity that might be right for you please contact our staff for more information. We are committed to helping you, your family and your physician make an informed choice in deciding whether an opportunity is right for you.

Thank you for your interest in Clinical Trials and Research!

Connect with us:

Mission Heritage Medical Group
Clinical Trials & Research
26800 Crown Valley Parkway, Suite 120
Mission Viejo, CA 92691
Phone: (949) 364-3612
Carrie.Mirza@stjoe.org