Renton, Wash.-based Rainier Clinical Research Center (RCRC) has expanded its early stage operations with the launch of a large phase I specialty unit within its existing facility. The center created the unit to help RCRC bring in the special patient populations that sponsors are now clamoring for in early stage research.

About 15 years ago the practice was incorporated as a clinical research center and initially focused on phase III and IV studies. When the center moved into its new facility in 2003, it added two overnight beds for early stage endocrinology work. It has since seen a rise in sponsor requests for those types of trials. To date RCRC has conducted several hundred trials, the majority of which have been in phase III and IV.

One of the main benefits of the new RCRC facility is its capability of accommodating patients for longer duration trials. The phase I unit has six in-patient beds for overnight studies and outpatient care capabilities using day beds. It also has seven dedicated exam and procedure rooms, and a large patient lounge area.

The center was originally founded as a medical practice in 1989 by Leslie Klaff, M.D., Ph.D.; Ronald Brazg, M.D.; and Allen Sussman, M.D.—all board certified endocrinologists.

“We are creating more of a boutique site where we really look at the type of patients we already specialize in. The vast majority of our studies have been in the area of diabetes, obesity and many of the complications of those diseases. What we try to specialize in is short-term overnight studies in special populations, with pharmacokinetics being a big part of that,” said Klaff.

Klaff is also a clinical professor of medicine at the University of Washington.

He went on to say that sponsors are asking the center to run intent-to-treat type studies, and stated that that type of study is becoming more and more popular.

“These are the half phase I-half phase II scenarios, where you do some initial phase I studies in patients, send them out for two weeks on the drug and then bring them back in for additional phase II-like testing,” Klaff explained.

RCRC performs a lot of continuous glucose monitoring studies—where patients need blood draws every 15 minutes over a 12-hour period–to compare against a monitoring device. These types of studies are common for both the development of medical devices and insulin research.

Like many well-established medical practices, RCRC has built up a large database of patients, many of whom suffer from metabolic diseases that the drug development industry is now focusing on more. The unit is located in Renton, a densely populated area of the state near both downtown Seattle and Tacoma.