97-11-07 Trustees: Center Established for Clinical Trials

NEW CENTER ESTABLISHED TO CONDUCT CLINICAL TRIALS OF NEW DRUGS

     COLUMBUS -- The Ohio State University Board of Trustees
today (11/7) agreed to help establish a new research company that
would conduct clinical trials on new drugs for the pharmaceutical
industry.

     The new organization, the Clinical Trial Management and
Coordinating Center, would be an independent, nonprofit
corporation which would contract with pharmaceutical firms to
conduct clinical trials.

     Before any drug can be approved for use with patients, the
federal Food and Drug Administration requires manufacturers to
test the drug on humans.  These tests, known as phase 1, 2 or 3
clinical trials, gauge a new drug’s safety and efficacy and
compare it with other drugs now in use for specific diseases.

     The new CTMCC would contract with Ohio State for the use of
university facilities, researchers and physicians to conduct
these trials.  It also would contract with physicians at other
institutions and in private practice in the United States and
throughout the world, as well.

     Trustees agreed to loan the CTMCC up to $2.5 million to help
establish the new program.  The loan would be repaid with
interest by the year 2001 and once the loan is paid back, the
university would share in the excess funds generated by the
center.

     The corporation would have nine directors, four of whom
would be nominated by the university to represent Ohio State’s 
interests in this new venture.

     University officials said that participation with the CTMCC
meshed well with the mission of the university, the Ohio State
University Medical Center and the James Cancer Hospital.

     “This Medical Center initiative represents a positive step
toward enhancing our research agenda and increasing funding for
research conducted here,” said Manuel Tzagournis, vice president
for health sciences.  “The corporation is beneficial to the
university because it will make it easier for companies to
contract with Ohio State University for clinical trials.  That,
in turn, will prove to be beneficial to our patients in the long
run.”

     Conducting these trials would increase university
researchers’ ability to study the latest drugs while at the same
time offer patients in Central Ohio, and in the areas of
participating physicians, better access to new, potentially
better treatments.

     The establishment of the center will provide opportunities
for all university departments that conduct clinical research,
explained Dennis Smith, director of administration for the James
Cancer Hospital.

     “Specifically in the area of cancer, this new arrangement
provides an opportunity for the James Hospital and the
Comprehensive Cancer Center to bring more promising new
investigational drugs to our patients, and thereby enhance their
care,” Smith said.

     Creation of the CTMCC follows a growing trend toward the
utilization of contract research organizations (CROs) to conduct
such trials.  In 1996, the pharmaceutical industry spent more
than $16 billion in research and development on new drugs -- $3
billion of that amount specifically to contract research
organizations.

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Contact:  Thomas Baxter, interim CEO, CTMCC, (614) 293-2585;
Baxter-1@osu.edu
Written by Earle Holland (614) 292-8384; Holland.8@osu.edu


[Submitted by: Von Vargas  (vargas.12@osu.edu)
               
Fri, 7 Nov 1997 16:44:58 -0500 (EST)]
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