At any one time, between 250 and 300 clinical trials involving thousands of patient participants are ongoing within the Emory Healthcare system. The trials are important for many reasons, but just because something is important doesn’t make it simple to administer—in fact, simplicity and importance often are inversely related qualities. That’s where Emory’s Clinical Trials Office (CTO) comes in.

CTO is a mechanism to facilitate the conduct and development of clinical trials at Emory. Not only does the office help investigators deal with the regulatory process, it assists Emory health care administrators in tracking the trials and their participants. CTO connects the two ends of the medical research bureaucracy (research and administration) and helps them communicate.

CTO Medical Director Peter Block is quick to stress that CTO does not run clinical trials at Emory, nor does it ever want to. Rather, the office is a tool which both researchers and administrators can use to make the entire clinical trials process easier for all involved.

“Our job, as I see it, is to lubricate the difficult gears and machinery of putting clinical trials through the Emory system and also make the Emory system more attractive to vendors and other sponsors of clinical trials,” said Block, director of interventional cardiology. He took over as CTO medical director July 1 and is moving quickly to ensure that all research staff remain fully knowledgeable and up-to-date on the often fluid regulatory requirements of clinical trials.

A research oversight committee, Emory’s Institutional Review Board (IRB), is responsible for approving and monitoring each clinical trial and its informed consent—a written document describing the clinical trial in detail that must be signed by participants before entering into the study.

CTO was founded in November 2001 as a unit of the School of Medicine. Although the office is small (just four people), it is capable of churning out an impressive workload.

“The volume [of current trials] is considerable,” Block said. “But not as much as it could be. There is no reason that the Emory system couldn’t support more than 500.”

While CTO works with both researchers and administrators, the tasks it performs for each are different. Investigators want to bring patients together for their studies and have those studies approved by Emory’s IRB and contracts office quickly. CTO works to make this process easier.

The hospital wants to keep track of patients. For instance, patients in clinical trials are billed differently than those who are not. If a clinical-trial patient comes into the hospital for a follow-up treatment or for an event unrelated to the trial, the billing process is different. It is the goal of the CTO to step in as a tracking mechanism.

Since the medical school’s divisions and the investigators working in those divisions often had their own internal ways of operating, and the communication between administration and investigation sometimes needed some streamlining, the CTO was created to make everything easier.

One of the ways CTO accomplishes this is through its SiteWorks web-based software information system which, once it is fully rolled out, will cover the regulatory, financial and administrative management of the nonclinical aspects of clinical trials. SiteWorks could be described as a new way of doing things—except for one factor.

“There really was no ‘old way’ [to track trials],” said SiteWorks system manager Missy Douglas. “Some people set up Excel spreadsheets; others used pencil and paper.”

SiteWorks is for research coordinators, financial managers and other financial people—all told, the system will have about 400 users, Douglas said. It provides a framework for the management of regulatory documentation, patient recruitment, financial planning, fiscal reconciliation and timely completion of trials.

Come Jan. 1, SiteWorks should be the default mechanism for tracking all new and current trials initiated within the School of Medicine. There are no plans to transfer information retroactively. Block said the goal isn’t to eliminate the tracking mechanisms of individual divisions, but it is necessary for all clinical trials to follow one format administratively.

Several trials are utilizing SiteWorks now, and managers not yet familiar with the system will have several opportunities to learn about it; more than 15 training sessions are scheduled between now and the end of 2003. For more information on CTO, visit www.emory.edu/WHSC/MED/RESEARCH/CTO/.