Central Kentucky Research Associates founder Deborah Dyer has a simple guiding policy when deciding whether to accept a study: “I won’t take a study unless it’s something that I would do myself, or that I would enter my mother or my child into. I can’t talk you into doing something that I wouldn’t do myself.”
When it opened in 1991, CKRA was the first independent clinical research facility in Kentucky, and Dyer faced some obstacles. A trained nurse with a background in gastro-intestinal research at the University of Kentucky, she found that banks were wary of funding her business plan because she was female, she wasn’t a doctor, and they just didn’t know what a clinical research facility did. “Twenty years ago, no one understood clinical trials,” Dyer recalls. “They didn’t understand the business and so didn’t understand what risks they might be taking.” Luckily, she persisted and CKRA has grown into a highly successful business with two offices, and a database of more than 30,000 potential study participants.
Nine years ago, Dr. James Borders joined CKRA and moved his practice to their offices on Richmond Road. This has several benefits. It enables recruitment of his patients for any studies that might suit them (although he notes that he will not accept study patients in his medical practice). More importantly, a doctor is on site at all times, meaning that if a study participant has questions, qualified help is always at hand.
One of the benefits that CKRA offers over a university setting for clinical trials is speed. With a centralized Internal Review Board (IRB), CKRA can typically work through the regulatory process in a much faster manner, which keeps the study sponsors happy. On the other hand, some studies will always need to be done within a hospital or university setting. For instance, CKRA does not do inpatient studies.
Dyer also sees a strong benefit for some study participants at CKRA – the provision of medical care. “Some of our participants don’t have medical care because they don’t have insurance. Others might have a primary care physician but they never go.” If there is a study looking into, for example, arthritis, and someone doesn’t have medical insurance, by participating in a trial, that person gets access not only to drugs that might ease their condition, but also to a full medical examination with x-rays and lab work. CKRA is not a primary care facility. Nevertheless, there have been times when they have found evidence of an underlying condition and can then refer that person to get help for something they may have been unaware of.
How long does a study last? A simple flu vaccine study may last just a few weeks, whereas a more complicated vaccine study can last a year. Studies into long-term effects of medications might last as long as three years, which can make retention of participants more difficult. As for the number of participants, some trials are so specific as to only have a handful here in Kentucky, while another might have several hundred.
To learn more about Central Kentucky Research Associates and current studies, visit www.ckraresearch.com.
By Fiona Young-Brown, Editor, KY Doc Magazine