The goal of our Clinical Research Center is to find new and better treatments for our patients. We study and test new drugs before the FDA (Food and Drug Administration) decides whether to approve or disapprove them for general use. Your involvement as a volunteer in a clinical study could aid in the developing new treatment options in the care of conditions such as asthma, nasal allergy (rhinitis) and chronic obstructive pulmonary disease (COPD).

Each year thousands of people volunteer to participate in clinical drug studies at our Center. Benefits to you as a volunteer may include:

• Medical care and study related medications during the time you participate.
• Learning about your medical condition from an experienced team of clinical research professionals.
• Financial compensation for time and travel if you are qualified to participate in the study.

What is a clinical research study?

A clinical research study is carefully designed to test the effects and safety of medications, medical treatment, or device on a group of volunteers. The goal of the clinical study is to test the drug’s ability to effectively treat a condition as well as its overall safety including assessing any possible side effects.

How is a drug approved for testing?

The U.S. Food and Drug Administration (FDA) typically must authorize a drug company’s plans on how they intend to conduct a clinical study. Drug companies must do years of laboratory research of new investigational medicines before testing is allowed in patients.

Who can participate in a clinical research study?

To qualify for a study, volunteers must not only have the disease being studied, but have the patient characteristics that are spelled out in the written study plan, or protocol. The physician conducting the study will review each volunteer’s medical history and determine if he or she meets the study requirements. If a patient volunteer is eligible to participate, known risks and possible discomforts of the study treatment will be carefully explained by the clinical research team.

What is Informed Consent?

Informed consent is the process designed to give study volunteers complete information about the potential benefits and risks of a study and the drugs being tested before they decide if they are interested in participating. This process allows the volunteer to ask questions and to exchange information freely with the clinical study team and the investigator. The clinical investigator (physician) is responsible for ensuring that the informed consent form is read, understood and signed by each research volunteer who agrees to participate in a research study. Research volunteers are permitted to participate in one clinical research study at a time. Each study participant will receive a copy of their signed informed consent form .

What is the Institutional Review Board (IRB)?

The IRB is a group of healthcare professionals and members of the local community which must review and approve a clinical study before it begins. The IRB carefully reviews study activities because its primary responsibility is to protect the safety and rights of the study participants.

How can I become a clinical research study volunteer?

Bernstein Clinical Research Center is continuously recruiting patient volunteers for various clinical studies. If you are interested in any of our ongoing clinical research studies:

1. Click here to e-mail us and complete a brief medical history questionnaire. Upon receipt, we will call you to discuss our current and upcoming clinical studies.

OR

2.Call 513-931-0775 extension 2 (suggest a phone box) to speak to a clinical research coordinator. The friendly staff of the Bernstein Clinical Research Center welcomes the opportunity to speak with you about our current and upcoming studies.