Clinical Trials
Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc, (“SacENT”) believes that an uncompromising commitment to safety and quality is the hallmark of ethical research. SacENT’s physicians and staff are committed to putting the safety of our clinical research participants first.

Safety is one of the largest concerns for most participants. The Pharmaceutical Companies that are affiliated with our studies have written Protocols that the on-site Physician Principal Investigator (one of our SacENT physicians) extensively reviews. The Food and Drug Administration oversees each process of the Clinical Trial, and an Institutional Review Board validates each Protocol and ensures the rights and safety of each study volunteer.

Currently, SacENT participates in only Phase III and Phase IV studies, which means we only test drugs that have already been proven safe and effective.

The Center for Information and Study on Clinical Research Participation ( http://www.ciscrp.org ) has provided the following useful information for patients and their families to help answer questions they may have regarding participation in a clinical trial.

What are clinical trials?

A clinical trial is a research study involving human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people and new ways to improve health.

Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set by the protocol.

Why are clinical trials conducted?

Many clinical trials are done to see if a new drug or device is safe and effective for people to use. Clinical trials are also done for other reasons. Some compare existing treatments to determine which is better. The current, approved treatments are called the "standard treatments." Sometimes, clinical trials are used to study different ways to use the standard treatments so they will be more effective, easier to use, and/or decrease side effects. Sometimes, studies are done to learn how to best use the treatment in a different population, such as children, in whom the treatment was not previously tested.

What are some of the possible benefits of my participation?

• Gain access to potentially new research treatments
• Receive expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied.
• Help others by contributing to medical research and treatment advances.

What are some of the possible risks of my participation?

• There may be unpleasant, serious, or even life-threatening side effects resulting from the treatment.
• The treatment may not be effective.
• Participation in the trial may be demanding and time consuming.

Key Questions to Ask Before Participating in a Trial:

• What is the main purpose of this study?
• Does the study involve a placebo or a treatment that is already on the market?
• How will the treatment be given to me?
• How long is the study going to last and what will I be asked to do as a participant?
• What has been learned about the study treatment and are any study results published?
• Do I have to pay for any part of the study? Will my insurance cover these costs?
• Will I be able to see my own doctor?
• If the treatment works for me, can I keep using it after the study?
• Can anyone find out whether I'm participating in the clinical trial?
• Will I receive any follow-up care after the study has ended?
• What will happen to my medical care if I stop participating in the study?
• Ask yourself - Are you comfortable with the doctor and study staff as they will be medical care providers during the study?

Current Clinical Trials:

ACCENTIA   ACC-05-01 Amphotericin B Suspension in Refractory Chronic Sinusitis PHASE 3 – A prospective, randomized, double-blind, placebo-controlled, multi-center, parallel-group study of intranasal amphotericin B suspension in patients with refractory, post-surgical chronic sinusitis. If you have had sinus surgery, are still having reoccurring sinus problems and are between 18 and 85 years old, you may qualify for this study

If you are interested in one of the Clinical Trials that SacENT is participating in, contact Debora at 916-736-6607 or dbasore@sacent.com