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March 4, 2002

New offices streamline clinical trials research

By Holly Korschun

The new Clinical Trials Office in the School of Medicine, along with the University’s new Office of Industrial Contracting and Liaison, are transforming Emory’s entire clinical trials process into a model of efficiency and best practices, with the ultimate goal of identifying the University as an academic health center of choice for industrial-, government- and foundation-sponsored clinical research.

From contracting with outside institutions to budgeting, working with institutional review boards, recruiting and managing patients, data processing and compliance with government regulations, the two new offices—both created late last summer—are dedicated to providing clinical trials investigators and coordinators with the education, tools, guidance and management required to create a streamlined process of conducting clinical trials from start to finish.

Ray Watts, A. Worley Brown Professor of Neurology, directs the new Clinical Trials Office (CTO), and Victor Lampasona directs the new Office of Industrial Contracting and Liaison (OIC). Both bring years of successful experience with clinical trials to their roles.

The two offices will work in tandem, with the CTO developing and implementing operational and management processes and the OIC negotiating external contracts and agreements and helping investigators navigate the processes of contracting, budgeting and management.

“These two offices will serve as catalysts to bring together all the Emory entities involved in clinical trials,” Watts said. “More than 200 investigators are conducting clinical research at Emory, sponsored by the pharmaceutical industry, medical device companies and biotechnology companies, in addition to government agencies. We want to streamline the clinical trials process and help our faculty and departments navigate all the regulatory, financial and operational issues expeditiously. At the same time, we want to ensure that all the proper checks and balances are in place so that we maintain the highest clinical and ethical standards for our patient volunteers.”

In the next five years, Watts said, Emory is poised to be a national leader in clinical research as well as discovery laboratory research. For patients, that means that in most, if not all, major disease categories, Emory will have physician-investigators on the leading edge of clinical investigations, with access to the newest and most innovative therapies. If a University investigator not only participates in clinical trials but also develops and leads multicenter trials, that will place Emory at the forefront of clinical research.

The benefits for Emory are threefold, Lampasona explained. “First, we create opportunities for our physicians and scientists to be intimately involved with the drug development process, perhaps influencing the way a drug is developed and ensuring its best use in the patient population,” he said. “This gives us the ability to provide the most innovative medicines to our patients, especially for diseases that lack effective treatments, and to bring those drugs to the forefront.

“Contracting with private industry gives us the ability to cover our direct costs and a small part of our indirect costs for clinical trials,” Lampasona continued. “By creating a separate office of industrial contracting, we recognize that corporate research needs to be handled differently than publicly funded research. Our staff has expertise in contracting as well as conducting clinical trials.”

The two new offices also expect to work closely with the Rollins School of Public Health and Nell Hodgson Woodruff School of Nursing, and with the Winship Cancer Institute, as well as Crawford Long and Grady hospitals, Children’s Healthcare and the V.A. Medical Center.

“As we move forward and focus our activities, we want to collaborate on clinical research with all of our Emory colleagues,” Watts said.

At least twice each year the offices will hold one-day symposia for new and experienced investigators, coordinators and clinical trials administrators. The sessions will address all aspects of conducting successful clinical trials and will form the basis for a procedure manual that assimilates best practices.

The first symposium, on “How to Conduct Clinical Trials Successfully at Emory,” will be held Thursday, March 28, from 9 a.m.–4:30 p.m. in the Emory Hospital Auditorium. It is aimed at experienced as well as new investigators, coordinators and administrators.

The symposium is free, and lunch will be served. Seating is limited to 200; participants can register by e-mailing the CTO’s Adrienne Tison at