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February 13, 2002


New Emory Clinical Trials Office and Office of Industrial Contracting and Liaison (OIC) Work to Streamline Clinical Research

The new Clinical Trials Office in the Emory University School of Medicine, along with Emory University's new Office of Industrial Contracting and Liaison, are well underway with executing plans to transform the entire clinical trials process at the university into a model of efficiency and "best practices." The ultimate goal of the two offices is to identify Emory 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 L Watts, M.D., the A. Worley Brown professor of neurology, directs the new Clinical Trials Office, and Victor Lampasona, Pharm.D., directs the new Office of Industrial Contracting and Liaison (OIC). Both bring many years of successful experience with clinical trials to their new roles. The two offices will work in tandem, with the Clinical Trials Office developing and implementing the operational and management process and the OIC negotiating contracts and agreements outside the university and helping investigators navigate the processes of contracting, budgeting and management.

The Health Sciences Center Strategic Plan for Research identified clinical trials as a critical area for improvement and future growth.

"These two offices will serve as catalysts to bring together all the Emory entities involved in clinical trials," said Dr. Watts. "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, said Dr. Watts, Emory is poised to be a national leader in clinical research as well as discovery laboratory research. For Emory 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 an Emory investigator not only participates in clinical trials, but also develops and leads multi-center trials, that will place Emory at the forefront of leading edge clinical research.

Corporations, government agencies and foundations seeking partnerships with academic medical centers look for investigators with the expertise to conduct clinical trials that incorporate the highest standards, within medical centers that have access to patients and the resources to assess and initiate trials expeditiously and efficiently.

The benefits for Emory are three-fold, Dr. Lampasona explains: "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. 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. 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 Schools of Public Health and Nursing and with the Winship Cancer Institute, as well as Crawford Long Hospital, Grady Memorial Hospital, Children's Healthcare of Atlanta and the Veterans Affairs Medical Center. "As we move forward and focus our activities, we want to collaborate on clinical research with all of our Emory colleagues," Dr. Watts said.

At least twice each year the Clinical Trials Office and the OIC 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. Drs. Watts and Lampasona believe the symposia will lead to improved communication among all the entities involved in clinical research.

Participants in the symposia also will be introduced to Siteworks, the new web-based clinical trials management software tool recently purchased by the School of Medicine. Siteworks will allow investigators and coordinators to smoothly negotiate all the steps involved in clinical trials, including building a budget, submitting IRB forms electronically, submitting contracts electronically, tracking patient recruitment and managing the entire process online. Eventually, all clinical trials at Emory should be developed using the new software over the next two years.

"Navigating the IRB process and the contractual and budgeting process can be a complicated task," says Dr. Watts. "We want to help investigators learn to promptly assess the scientific importance of a trial, its fiscal soundness and patient availability, along with techniques such as parallel processing of the IRB application and budget/contract negotiations simultaneously that can expedite the trial. If you have the expertise and the patients and you can conduct a trial expeditiously and efficiently, corporations and agencies not only will return to you the next time, they will spread the word about your expertise."

The first day-long symposium on "How to Conduct Clinical Trials Successfully at Emory," will be held Thursday, March 28, from 9:00 a.m. until 4:30 p.m. in the Emory University 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, so registration is required. Participants can register by emailing Adrienne Tison in the Clinical Trials Office (

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