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Industry-Academic Initiative Sets Clinical Trials In Motion

Columbia University Medical Center has been selected by Wyeth Pharmaceuticals to join its Early Clinical Development Center (ECDC) Initiative, which includes a group of clinical sites selected to conduct early phase drug development clinical trials across a broad range of therapeutic areas. CUMC is among the initial 10 centers invited to join the worldwide ECDC Initiative and the first academic center in the United States. Wyeth expects that the ECDC Initiative will expand to approximately 15 sites. The unique arrangement allows investigators to participate actively in the development of new drugs to benefit patients.
   The therapeutic areas include women’s health, cardiovascular and metabolic diseases, inflammatory diseases, oncology/hematology, anti-infectives, neurosciences, and vaccines.
   “As the NIH dollar shrinks, collaborations with pharmaceutical companies enable our physicians to conduct the research they would like to do but might not otherwise have the opportunity to do,” says Eileen Enny Leach R.N., M.P.H., director of the Clinical Trials Office, (CTO), a joint operation between CUMC and NewYork-Presbyterian Hospital that facilitates and initiates clinical trials at the medical center and supports patient-oriented research. The CTO negotiated the agreement with Wyeth. Already, physician-investigator interest has been high across the therapeutic areas. All principal investigators who participate in the trials will be at the associate professor level or higher.
   “In these early Phase 2 trials, investigators can help the company decide which compounds have the most promise and which have little efficacy,” says Ms. Leach.
   The CTO provides wide-ranging investigator support: negotiating contracts; reviewing and approving budgets; sponsoring a searchable clinical data warehouse containing data from inpatient and ambulatory patients; a research pharmacy; and, together with the Irving Center for Clinical Research, a Hispanic Translation Center. In addition, the CTO supports investigator-initiated clinical trials through pilot and infrastructure awards. These awards have exceeded $3 million over the past 10 years.
   In the past, most trial designs called for a single treatment allocation scheme. In a departure from the norm, the FDA has recently explored the concept of “adaptive designs,” that is, the treatment allocations may be adjusted in a pre-specified way to allow the sponsor and the physician-investigator to understand a compound’s profile sooner. Some of Wyeth’s trials in this collaboration will fit this design model. Investigators will also have publication opportunities and, as usual, the responsibility to report any adverse events to the regulatory authorities.
   “For a pharmaceutical company to come to an academic medical center with a project of this magnitude is unique. The trend has been for sponsors to go to a private clinical research organization to conduct trials,” Ms. Leach says. “A contract like this reverses the downward slope that some medical centers have experienced in sponsored clinical trials. We expect real advances for both patients and investigators to result from this association.”