What is a clinical trial?
A clinical trial is a research study intended to answer specific questions involving medications, medical devices or new ways of using known treatments. Carle Clinic Association conducts clinical trials to determine whether new drugs, devices or treatments are both safe and effective. All research conducted at Carle Clinic is reviewed and approved by an Institutional Review Board.

What is the purpose of a clinical trial?
Most clinical trials provide short term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the patient's healthcare provider work with the research team, the patient can ensure that other medications or treatment will not conflict with the protocol.

What are the benefits of a clinical trial?
Participants play a more active role in their own health care, can gain access to new research treatments before they are widely available and will help others by contributing to medical research. Consult your physician for advice on weighing the benefits and risks of participation.

Are there any participation guidelines?
All clinical trials have guidelines about who may or may not participate. These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before enrolling a clinical trial, a participant must qualify for the study. No one is ever enrolled in a clinical trial without previous knowledge and written consent.

How is Carle Clinic involved in a participant’s care in a clinical trial?
Our clinical research team (doctors, nurses and other healthcare professionals) assesses the health of the participant, provides detailed instructions for participant, monitors the participant carefully during the trial and stays in touch after the trial as needed. Occasionally, a trial may involve additional tests and doctor visits. While in a clinical trial, participants are seen regularly by the research staff to monitor their health and determine the safety and effectiveness of the treatment.

Who regulates the clinical trial process?
The Food and Drug Administration (FDA) and the Office of Human Research Protection (OHRP) develop the policies and guidelines for all medical research. An Institutional Review Board reviews and approves all study-related documents, such as protocols, informed consent forms, physicians’ credentials and eligibility and patient recruitment materials.