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
(atison@emory.edu).
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