Am I Eligible?

As a Baptist Health patient, you may become aware of a clinical trial because your physician or someone on our medical staff may consider you a potential fit for one of our studies. Or, you may hear about a trial that interests you, and inquire about it at a Baptist Health facility. In both cases, you will undergo an evaluation to determine eligibility.

Each clinical trial has criteria for determining who can participate. The document containing guidelines for the study, or the study protocol, lists these criteria. The guidelines are based on personal characteristics, such as age and sex, health status, family history, and the nature and progress of the medical condition. The Baptist Health clinical trial/study coordinator will review your medical record, ask you questions, and speak with your physician regarding your suitability.

Not everyone is eligible to participate in a particular trial. You may discover that you are ineligible during the evaluation process, or that you are eligible for a different trial than the one you first you considered. Standard medical treatments are available for anyone who is ineligible for a clinical trial.

Assessing Eligibility

Several individuals are involved in the evaluation process and are there to support you as we determine eligibility. Your physician will likely be the first person to discuss participation with you. He or she will lay out the potential benefits and possible risks of the trial. If, after this discussion, you are interested in pursuing the trial further, your physician will contact a Baptist Health research coordinator to continue the evaluation.

The research coordinator works closely with the treating investigator (physician) and is the person responsible for the day-to-day activity of a trial, including educating and enrolling new participants. The coordinator will:

• Meet with you one or more times, as needed
• Provide you with detailed information about the clinical trial
• Review the consent process and make sure you understand everything you need to know before you decide whether to commit
• Request your medical records to verify your eligibility for participating in the trial
• Answer any questions you may have

The Baptist Health study coordinator will complete your evaluation and contact you or your physician with the decision on your eligibility. If you are selected for the trial, he or she will schedule a meeting to finalize your consent and arrange any necessary tests or procedures to begin your participation.

Learn more about Clinical Trials at Baptist Health.

What Is a “Protocol,” Anyway?

A protocol is the document that defines a clinical trial. Its goal is to answer specific research questions and protect the health of participants. It contains the following information:

• The reason for conducting the study
• Who may participate in the study (the eligibility criteria)
• The number of participants needed
• The schedule of tests, procedures, or drugs and their dosages
• The length of the study
• What information will be gathered about the participants
• ClinicalTrials.gov Web site U.S. National Library of Medicine