Clinical Trials

What is a clinical trial?

A clinical research study or trial is a scientific study evaluating a new treatment that has shown promise in laboratory studies. It is a scientific study of how a new medicine or treatment works in people. Through clinical studies, doctors find new and better ways to prevent, detect, diagnose, control, and treat illnesses.

A clinical research study is undertaken through volunteers who would like to participate in advancing medicine. Careful oversight and patient care steer the trial toward meaningful outcomes.

The Food and Drug Administration (FDA) requires clinical trials to be performed on all new and improved medications before that new treatment becomes available for public use. Prior to a new drug reaching a clinical research trial, many years are spent testing medications in a laboratory to determine the medication’s safety and usefulness. That means every medication you’ve ever received went through this same process.

A study sponsor is the pharmaceutical company, research institution, or other health organization that funds a clinical research study and designs its protocol. Every trial is sponsored by one of these organizations.

A clinical investigator is a medical researcher in charge of carrying out a clinical research study’s agenda. This person is usually a doctor or pharmacist but can be a nurse or other health care professional. He or she follows a carefully designed and detailed study plan created by the study sponsor.

The clinical research coordinator is a health care professional you will meet with during a study. They are under the supervision of the clinical investigator and maintains all research documents throughout the study process. They also coordinate tests and procedures, so all study visit requirements are scheduled and implemented.

Why Volunteer?

Volunteering as a patient has many benefits, both for the volunteer and the entire community. Participants may receive medical care related to their studies at no cost. Volunteering may help you better understand your condition and may potentially reduce the cost of health care. Volunteers are compensated for their time and travel.

Our patients are a vital part of developing future medications to manage, prevent, and cure diseases that make significant impacts in our communities and our country.

What to Expect

If you are new to clinical research, we realize that this process may be confusing. Don’t worry, we will walk you through it and provide any explanations you need during each step of the process.

Please realize that each study has a very specific set of qualifications. These criteria must be met in order to participate. We’ll discuss these qualifications with you by phone or in-person and help determine if you’re a candidate for a study.

If selected, you will receive care related to the study at no cost, and we will take the time to get to know you and your medical conditions.

If all other requirements are met, you will have ample time to review the informed consent document. You will meet with both the Research Coordinator and Physician to answer any of your questions prior to signing the Informed Consent Document. The time frame and requirements of the trial are explained, and all questions are answered.

During a trial, you can expect to be given the investigational drug, a placebo, or a currently available treatment. You can also expect to be seen by the research coordinator at each visit.

At the end of each trial, you should expect to return any unused study drug and you will be asked to complete a short questionnaire about your experience.