Clinical trials are research studies that evaluate the effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available. They are a critical component of medical research.

Participants are generally divided into two or more groups, including a control group that does not receive the experimental treatment, which receives a placebo (inactive substance) instead, or receives a tried-and-true therapy for comparison purposes.

Typically, government agencies, such as the Food and Drug Administration (FDA) approve or disapprove new treatments based on clinical trial results.

Usually volunteers are recruited, and in some cases research participants may be paid. Typically, participants must meet specific criteria and/or have been diagnosed with a specific disease in order to qualify for a clinical trial study.

There are many reasons to volunteer for a clinical trial study and the reasons vary for different people and their situations.

For some patients, clinical research trials represent an avenue for receiving promising new therapies that would not otherwise be available. Patients with difficult to treat or currently incurable diseases, such as AIDS or certain types of cancer, may want to pursue participation in clinical research trials if standard therapies are not effective.

For others, there may be a genetic disease in their family and by participating in a clinical trial they may help future generations by finding an effective medication or cure. Clinical research trials are sometimes lifesaving and help people around the world.

Yes, clinical trials are accomplished in four phases.

Phase I is the first phase of testing in which healthy volunteers participate. These are typically short-term and establish the safety and tolerance of the medication. In Phase I studies, the participant is usually treated as in-patient which means that they are kept on-site and very closely monitored.

Phase II studies are usually short to medium duration and utilize volunteers with specific criteria or disease. This phase is used to define the medication dosages.

Phase III are usually the last studies completed before the medication is submitted for approval from a government agency such as the FDA. Phase III studies vary in length from several months to several years and require many volunteers with the appropriate disease or symptoms for the medication being studied. These studies determine the medication’s safety and effectiveness with the selected dose in a large sample of participants and establish guidelines as to how the medication should be used. Phase III studies typically include a placebo (inactive substance), which means that some participants are not on active medication.

Phase IV studies are conducted after the medication has been approved. These studies are used to monitor the safety of the medication, as well as continuing to record information regarding side effects, in large groups of volunteers.

Aurora Care Clinic conducts Phase II, III, and IV studies.

Click here to submit a request for information. Or you may click here to complete a registration form and return it to our office either by fax or email. Either way, someone from our staff will contact you within 24 hours. You may also call our office at 714-285-9070 to submit a registration by phone. Click here to see a list of currently enrolling or upcoming studies.

Typically, there will be no cost to you or your insurance company for tests performed or for study related procedures and study medication during the clinical trial.

In the event that you qualify for and consent to a research study, you may be compensated for participation in that study in order to cover travel expenses and for time spent participating in the study.

Clinical trials consist of office visits similar to visits that you would make to your own doctor and may include ECGs, X-rays, pulmonary function tests, physical examinations, questionnaires and lab work. Each trial consists of procedures specific for that study. Typically, all study related procedures and study medication are provided free of charge. Each trial has its own specific requirements that must be met in order to qualify for the study. Trial participants are treated compassionately, professionally and with respect.

No. Tests will be performed based upon the requirements for each individual study. If we believe that you may qualify for a research study, you will be provided with a detailed consent agreement customized for the study in which you may be enrolled. Whether you are a good candidate for the study or not, you will be provided with your screening test results for your records and we will be happy to explain the results to you.

No. Participation in a clinical research study is not intended to substitute for medical treatment, evaluation or care from a personal physician. Aurora Care Clinic is a research facility and does not provide medical evaluation or medical care that might be offered from a personal physician.

Participating in a clinical trial does not substitute for a primary care physician or specialist and the test results are provided for your information only. If your test results are not within the normal range, please follow-up with a physician.

You will be required to read, understand and sign a consent form that will provide you with information about the study. The consent will describe the study, the schedule of visits, what is expected of you, procedures that will be done, the name and phone number for a person that you can contact with questions or concerns, the amount of monetary compensation, and a list of any potential risks and benefits. It is recommended and encouraged for you to show the consent form to your primary care physician so that your physician will be aware that you are participating in a Clinical Trial. We are available to answer all of your questions prior to signing the informed consent and no study procedures will be done before the informed consent is signed.

Your decision to participate in a clinical trial is completely voluntary at all times. If you decide not to participate in the study, or if you decide to withdraw from the study before it is complete for any reason, there will be no penalty to you. Doing so will not impair your ability to participate in other research studies in the future.

Different studies require multiple types of tests and may include the following:

• Medical and social history
• Limited physical examination, including height and weight
• Vital signs
• Electrocardiogram (ECG)
• Blood and urine testing
• Chest X-ray
• Pulmonary Function Test (PFT)

Yes. We will keep all records confidential, except as required by law. The medical staff and/or doctor will review your results and information in order to establish eligibility for possible participation in a research study as well as during the life of the Clinical Trial. Additionally, pre-screening records may be provided to regulatory agencies such as the United States Food and Drug Administration (FDA) or the study sponsor if you qualify for and participate in a research study. You will receive a specific research study authorization detailing the use and disclosure of your health information if you are enrolled in a study.

You may call us at 714-285-9070 or email us at info@auroracareclinic.com.