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 scientists."

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 trials activity.

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.