Clinical Trials Give Participants Access to Advanced Care

As a research institution, the University of Kentucky is able to offer people in and around the Central Kentucky region the opportunity to access cutting-edge health care - while furthering the advancement of scientific knowledge - through participation in clinical trials.

A clinical trial evaluates - in humans - a drug, device or mode of therapy for a disease. All therapies put into use in the U.S. go through a rigorous process of testing, culminating in evaluation of the treatment in human research participants. In order to test new treatments, clinical trial investigators at research institutions like UK must recruit participants willing to contribute to science, while often reaping the benefits of advanced treatment for themselves, and gaining access to top clinicians and the latest medical information.

"The purpose of a clinical trial is to learn something new about people, about diseases and about treatments," said Dr. Leslie Crofford, chief of the UK Division of Rheumatology, and director of theUK Center for the Advancement of Women's Health, home to the Kentucky Women's Health Registry.

Participating in a clinical study contributes to medical knowledge. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative or diagnostic products or interventions. Clinical trials provide the basis for the development and marketing of new drugs, biological products, and medical devices.

Clinical trials may be interventional, wherein a treatment or medication is administered to an experimental group.  Or, it may be observational where no intervention is performed, but participants are observed and monitored to learn more about their conditions. A variety of clinical trial designs means that some studies may specifically recruit people with a certain condition, while others may recruit healthy volunteers.

"I would tell anyone who has a condition and is thinking about becoming part of a clinical trial that it is one of the most empowering things that people can do. It allows you to learn about a condition that may afflict you or a family member. It allows access and contact with investigators that are very knowledgeable about the condition. It allows a sense that you are doing something active to help not only yourself, but other people with the condition," said Crofford.

Some may have reservations about participating in a clinical trial, including concerns about safety, privacy and oversight.

"I think the most important thing for the public to understand is that clinical trials are very carefully thought through and very carefully supervised for safety, and there has to be a point to it, there has to be a reason for doing the trial," said Dr. Philip Kern director of the UK Center for Clinical and Translational Science (UK CCTS) and director of the Barnstable Brown Kentucky Diabetes and Obesity Center.

There are several ways to connect with clinical trial opportunties. UK maintains a database of potential research participants who self-refer, and contacts participants when a study matching their interests and health needs opens for enrollment. The university also maintains the Kentucky Women's Health Registry - a survey-based instrument used to track the health of Kentucky's women, while also allowing interested participants to be matched with pertinent clinical trials. Anyone can view currently available clinical trials at the university at any time viahttp://www.UKclinicalresearch.com. Participants may also connect with clinical trials through their physician, or through national listings like those at http://clinicaltrials.gov/.

However a participant connects with a clinical trial, it's important that they understand the trial methodology, purpose and procedures. The UK CCTS has put together a helpful list of questions for clinical trial participants.

"I view participation in clinical research as a form of empowerment for anybody who has a health concern, not only for themselves, but for their families," said Crofford.