Location: 6035 Shallowford Road
Owner: Wake Research Associates, L.L.C.
Founder: Dr. Richard Krause, a retired gastroenterologist
Staff: 11 employees
Services: The company tests new drugs and medical applications on volunteer patients for pharmaceutical companies
Bringing drugs to market
The path a drug travels from the lab to your medicine cabinet usually takes years and involves three phases. ClinSearch helps conduct work on three of the four trial phases:
Phase 1 Usually involves 20 to 80 volunteers, watched overnight to determine what the drug’s most frequent side effects are and, often, how the drug is metabolized and excreted.
Phase 2Usually involves a few dozen to about 300 volunteers to obtain preliminary data on whether the drug works in people who have a certain disease or condition. For controlled trials, patients receiving the drug are compared with similar patients receiving only a placebo or a different drug.
Phase 3Involves up to 3,000 volunteers to evaluate the drugs effectiveness at different doses and with different drugs among differing populations.
ClinSearch has information about ongoing drug trials and how to participate on its web site at clinsearch-us.com/volunteer-info/
At age 70, Richard Krause is still on the cutting edge of new medical treatments.
Dr. Krause retired from his own medical practice more than a decade ago, but the drug trial and testing business he started in 1996 — ClinSearch — has grown into Chattanooga's biggest clinical drug trial business.
Krause has been a medical pioneer of sorts in Chattanooga since he came to town in 1977 as one of the city's first gastroenterologists after serving internships and working at Grady Hospital in Atlanta, Yale University in New Haven, Connecticut, and University of Massachusetts in Worster, Massachusetts. Dr. Krause helped open GI labs at both Memorial and Parkridge hospitals and went on to help bring the first ERCP (Endoscopic Retrograde Cholangiopancreatography) and papillotomy to town. He later opened one of the region's first physician-owned endoscopy labs.
ClinSearch is another venture Dr. Krause launched, in part to give patients access to new medicines and to help Chattanooga participate in testing new treatment technologies and drugs.
The drug testing company conducts its clinical trials for most major pharmaceutical manufacturers and advertises regularly on radio and television and in the newspaper to recruit volunteers with particular ailments or diseases to help test out new drugs. The volunteers don't know if they are getting the real drug or a placebo, but they are monitored closely during the trial to assess their health and any impact from the new drugs. ClinSearch patients are paid for their travel and expenses, along with a small stipend.
"Some people volunteer because they want to try out new drugs and help new medical treatments, and others do it because they like the idea of getting no-cost drugs and medical assessments, as well as getting a small payment," Krause said during a recent interview at the company's Shallowford Road storefront facility.
The Volunteer State lives up to its name, Krause said, and the Chattanooga area is big enough and ClinSearch's facility accessible enough for ClinSearch to get the dozens — or in some instances hundreds — of volunteers needed for each of its drug trials.
"We usually do about 20 studies at a time," Krause said. "We look for patients who are not responding to other medications and are willing to volunteer for our tests. We can help people who couldn't otherwise afford their medication."
Every clinical trial is carefully designed to answer certain research questions. A trial plan called a protocol maps out what study procedures will be done, and even ClinSearch's staff doesn't know whether those being tested are getting the actual drug or a placebo. The clinical trial team includes doctors and nurses, as well as other health care professionals. ClinSearch forwards all health data to the primary care or treating physician for each volunteer.
"Some people think we use "Guinea pigs," but I prefer to call them "Guinea people" because our volunteers are free to drop out of the study at any time," Krause said. "Over time I think we've developed a great reputation, both for our volunteers and the drug companies for which conduct our trials. That has helped to limit the number of those who leave our trials early."
ClinSearch was recently recognized for the INC Clinical Research award for 2016 from among facilities that were testing a new treatment for migraine headaches. ClinSearch was recognized based upon the quality, compliance and accuracy of its clinical trials.
Last year, Krause sold his company to Wake Research Associates, L.L.C., a Raleigh, North Carolina-based network of clinical research sites in about a dozen cities across the South. Wake Research conducts clinical trials in all major therapeutic areas with particular experience in internal medicine, dermatology, women's health, metabolic diseases, gastroenterology, men's health, neurology, pulmonology, rheumatology, vaccines and women's health trials.
Krause continues to oversee ClinSearch for Wake Research.