Moving Ahead on Expansion of Jefferson's Clinical Trials Activity
Increasing clinical trials activity at Jefferson is the next
step in the comprehensive plan initiated by Joseph S. Gonnella, MD, senior
vice president for academic affairs and dean, Jefferson Medical College
(JMC), to ensure Jefferson's future as a leading academic medical research
center. In appointing Gerald Litwack, PhD, associate dean for scientific
affairs, JMC, Dr. Gonnella has identified the person to put the clinical
trials phase of this plan in motion.
Dr. Litwack is also associate director of Jefferson's Kimmel Cancer Center,
deputy director of the Kimmel Cancer Institute, and professor and chairman
of the department of pharmacology.
"Jefferson's strategy has been to develop an infrastructure where teams
of basic scientists of outstanding reputation were recruited to complement
our outstanding clinicians," Dr. Gonnella points out. "And what
makes Jefferson unique is that we have developed a new breed of scientists
eager to work collaboratively in interdisciplinary teams." This collaboration
among basic scientists and clinicians will enable Jefferson to move quickly
in translating our research breakthroughs from "bench to bedside."
Jefferson's suitability as a clinical trials site is also enhanced by our
partnerships, such as the Jefferson Cancer Network, Jefferson Health System
and Medical Center of Delaware, through which we can access the large patient
populations necessary to conduct Phase III clinical trials.
Dr. Gonnella envisions that word of our new approaches will draw greater
numbers of patients seeking care and participation in trials. He believes
that marketing the strength of our outcomes will benefit clinicians as well
as the hospital.
Dr. Litwack chose expansion of clinical trials at Jefferson to be one focus
of activities in the Office of Scientific Affairs. He is now concentrating
on attracting to Jefferson private-sector pharmaceutical companies and contract
research organizations (organizations that act as intermediaries between
the pharmaceutical industry and people who conduct research).
Dr. Litwack believes that his objective to double Jefferson's clinical trials
activity is realistic. He says, "I think this is a realistic goal.
If I am selective, I can make a difference in Jefferson's interactions with
the pharmaceutical industry."
Jefferson has centers of clinical research excellence, such as the Kimmel
Cancer Center and many others, with academic clinicians and basic scientists
of the highest caliber and integrity interested in conducting clinical trials
in their areas of expertise," Dr. Litwack says. "I need to match
our centers and scientists with pharmaceutical companies and contract research
organizations (CROs) who are ready to conduct clinical trials of innovative
drugs and devices. This will expand Jefferson's opportunity to cure and
treat disease as we strengthen cooperation with industry. It will bring
increased revenue to Jefferson to offset the price and cost controls that
accompany managed-care and the diminishing support from federal agencies."
How will this matchmaking occur?
Dr. Litwack has already developed an information-gathering questionnaire,
which was sent to clinical faculty early this year, surveying their interest
in conducting clinical trials. He encourages volunteer faculty members who
have an interest in conducting clinical trials and would like to receive
this questionnaire to contact Tom Murray, Office of Scientific Affairs,
M-77, Jefferson Alumni Hall, at 3-0204. So far, approximately 170 clinical
scientists have responded.
In development is a handbook highlighting Jefferson's centers of excellence
and clinical faculty, their research interests, past experience or potential
experience in testing new drugs or devices with patients in clinical settings.
"The handbook will launch our campaign with the pharmaceutical companies.
It will reveal the depth and the breadth of Jefferson's expertise and capabilities
in conducting clinical trials," Dr. Litwack says. Each company Jefferson
contacts will receive the handbook and will be encouraged to use it to "match
their needs with Jefferson's extraordinarily capable clinicians and basic
In addition, Dr. Litwack has begun the process of budget preparation and
forecasting for development of a clinical trials office at Jefferson. He
has appointed John J. Schrogie, MD, assistant director, Office of Health
Policy and Clinical Outcomes at Jefferson, to be director of clinical trials
starting in July. The clinical trials office will deal directly with pharmaceutical
companies, answer their questions, address their concerns, and generally
become their facilitator in instituting clinical trials at Jefferson. Dr.
Schrogie, a clinical pharmacologist, was the founder and CEO of the Philadelphia
Association for Clinical Trials (PACT), a contract research organization,
and has spent his career in clinical research and development.
How will the office of clinical trials work?
"The interested pharmaceutical company or CRO would call the director
of clinical trials at 503-5573, explain their needs, and rapid negotiation
would begin. The director would do the footwork to line up the appropriate
investigator with the pharmaceutical company or CRO and bring the trials
to Jefferson," Dr. Litwack explains. "Essential to our success
will be reinforcing the fact that calling on Jefferson to conduct clinical
trials is not only an economically sound decision but also the most trouble-free
and beneficial way for a pharmaceutical company to proceed."
Patients who are interested in participating in clinical trials conducted
at Jefferson should contact 1-800-JEFF-NOW
What are the challenges ahead?
Creating smoothness of operation in the clinical trials office involves
countless hours of behind-the-scenes strategizing to identify any potential
difficulties and eliminate or polish them before the office becomes operational.
"Among our priorities is establishing fees that will be attractive
to industry," Dr. Litwack explains.
Still to be determined is the impact on the Institutional Review Board in
handling this expanding clinical trial activity. Being able to include the
growing number of Jefferson Health System institutions and clinicians who
are also interested in conducting clinical trials demands that our regulatory
efforts can adjust to handle increased activity.
In moving forward, Dr. Litwack says, "Jefferson must make our incredible
strengths in the area of clinical trials known to both the pharmaceutical
companies and CROs. It's a matter of educating them about our capabilities
in providing a site for their clinical trials and then being able to deliver
seamless service at competitive rates."
The support given Dr. Litwack's project by Jeffersonians has been enormous.
Dr. Gonnella spoke with the executive council to inform clinical chairs
and faculty about his commitment to this important venture. Alan L. Brechbill,
associate executive director and chief operating officer for the hospital,
has focused his efforts on coordinating the various hospital departments
that will play a role.
While the major office involved in this endeavor will be the Office of Scientific
Affairs, David B. Nash, MD, MBA, director, Office of Health Policy and Clinical
Outcomes, has shared his wealth of information and lent support to Jefferson's
development of contractual relationships with industry. Dr. Nash has recently
established the Office of Scientific Training and Education, also headed
by Dr. Schrogie, which will conduct training programs to support clinical
Clinicians and department chairs such as Jose´ F. Caro, MD, medicine;
Walter J. Curran Jr., MD, radiation oncology; James E. Fish, MD, pulmonary
medicine; S. Grant Mulholland, MD, urology; John L. Randall, MD, family
medicine; Richard H. Rothman, MD, PhD, orthopaedic surgery; Alan R. Spitzer,
MD, pediatrics, and their staff members have expressed willingness and eagerness
to cooperate and participate in expanding our clinical trials activity.
For more information about Jefferson's clinical trials' activity, call 3-6976.