LEXINGTON, Ky. (Nov. 7, 2012) - The following column appeared in the Lexington Herald-Leader on Sunday, Nov. 4.
Every year, thousands of clinical trials are launched in the United States to evaluate new therapies. Volunteers, both those who are healthy and those who’ve been diagnosed with a disease, are needed for human testing of new drugs, procedures and devices. The purpose of a clinical trial is to determine the safety and efficacy of a potential new therapy.
Participating in a clinical trial offers access to cutting-edge therapies, treatment by leading health care providers and the opportunity to contribute to science. Clinical trials, which are supervised by review boards to minimize risk to participants, are carefully monitored studies that take place after a therapy has passed rigorous laboratory and animal testing.
Finding a clinical trial for which you may be eligible can be as simple as an internet search. Sites like Clinical-Trials.gov list available trials across the country. Institutions like the University of Kentucky also maintain their own registries of people interested in clinical trial participation, and contact potential participants when a trial matching their health needs and interests begins enrollment. Physicians may also be able to connect their patients with clinical trials.
Before enrolling , participants should ask several questions, including:
• What treatment will be provided as part of the study?
• Who will provide care to participants?
• How long will the study last?
• What will be required of the participants?
• What compensation, if any, will be offered for time and travel?
• What are the potential risks and benefits of participation?
• What type of long-term follow-up care is included?
The answers to many of these questions can be found in the informed consent document participants must sign before enrolling in a trial. It’s important to note that informed consent is not a contract — a participant may withdraw their consent and leave a study at any time.
Clinical trials may involve several visits to a health care provider, or even hospitalization, as participants are monitored closely for effects — positive or negative.
Every possible precaution is taken to minimize risk.
Participating in a clinical trial, whether as a healthy volunteer or as a person seeking the latest treatment, offers the opportunity to know you are contributing to science in a meaningful way. Research volunteers directly impact the development of emerging therapies and are the front line in fighting conditions from cancer to childhood illnesses. Development of new therapies hinges on the willingness of trial participants to accept some level of risk in exchange for the opportunity to experience the latest clinical advances.
Dr. Philip Kern is the Director of the University of Kentucky Center for Clinical and Translational Science.