The new Clinical Trials Office in the School of Medicine, along
with the Universitys new Office of Industrial Contracting
and Liaison, are transforming Emorys 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
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 officesboth created late last summerare 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
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
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
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, Childrens Healthcare and the V.A. Medical
As we move forward and focus our activities, we want to collaborate
on clinical research with all of our Emory colleagues, Watts
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 CTOs Adrienne
Tison at email@example.com.