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The Clinical Trials Network


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The Clinical Trials Network

A cooperative program that links sponsors and investigators with academic physicians, clinicians and an enormous diversity of patients

Finger pointing at computer In the complex world of medicine, the ultimate goal is to transform theory into practice, hope into cure. The challenge is to unite the resources necessary to solve the puzzle of human illness and treatment. That challenge is being met every day by The Clinical Trials Network (CTN).

CTN is an innovative clinical trials organization formed by Columbia University, Cornell University and the New York Presbyterian Hospital and Health-care System. It is managed by the Office of Clinical Trials (OCT) and offers an extraordinary richness and depth of resources. Our Network connects over 15,000 excellent physicians and a diversity of patients to the exceptional facilities and intellectual capabilities of our academic medical centers and affiliated hospitals. CTN supports all aspects of the management and conduct of clinical trials and protects the highest standards of medical science and the ethical treatment of participating patients. This unparalleled combination of resources has created a remarkably powerful research network. In our case, the sum is truly greater than the individual parts.

CTN is organized around five therapeutically focused groups: Cardiovascular (CCTN), Liver (LCTN), Neurology (NCTN), Oncology (OCTN) and Primary Care (PCCTN). These specialty groups, guided by a Medical Director and an Advisory Council, consist of expert clinical investigators drawn from practice sites within our healthcare system.

The outcome of any clinical trial hinges upon the accurate and timely collection of research data. Clinical Site Managers, a unique feature of CTN, enable our participants to meet the highest standards of excellence in clinical research through training and quality assurance. The Clinical Site Managers (CSMs) provide day-to-day support and work with sponsors on site selection, consent form development and study initiation. For the investigators, they are an invaluable resource responsible for training the staff in Good Clinical Practices (GCP), supporting the work of study site coordinators, and preparing for important monitoring visits. CSMs assess the progress of studies, the quality and performance of team members, and serve as a vital link to the Medical Directors and practice sites.

CTN joins sponsors with academic researchers and skilled physicians who manage patients throughout the tri-state area. But the coordination and organization of such a vast system requires superior centralized management—The Office of Clinical Trials.

Collage of hospital images

A collective of people dedicated to investigative research and 
the ethical treatment of patients

Allowing Doctors to Be Doctors

The growth of managed care has placed an enormous burden on our doctors. In order to simply maintain their current incomes, they must work longer hours, see more patients and spend valu-able time filling out insurance forms. The Office of Clinical Trials (OCT) is a centralized administrative organization for clinical investigations that lifts the non-medical obligations from the physicians—allowing doctors to be doctors.

Created in 1992 as a partnership between Columbia University and the former Presbyterian Hospital, the Columbia University/New York Presbyterian Hospital Office of Clinical Trials has negotiated more than 700 clinical trial agreements with a value in excess of $170 million. It has worked with more than 190 corporate sponsors and virtually all of the Institutes of the NIH, as well as numerous charitable organizations and foundations across the United States. Representing the coordinating centers for large multi-national clinical trials, OCT has entered into subcontract agreements with more than 250 hospitals, medical centers and practice sites in North America.

In support of the clinical research process, OCT’s various facilities include a dedicated research pharmacy, the Hispanic Research and Recruitment Center, a core research computer and a sophisticated Data Warehouse. Consistent with the mission of our academic medical centers, OCT has invested in teaching and training programs. As a result, Columbia University’s Schools of Nursing and Public Health now offer Master’s degree programs in clinical research for doctors and nurses. Fundamental training is essential for all participants in clinical research, and accordingly OCT has conducted, for over five years, regular courses in Good Clinical Practices (GCP) and published a training video and textbook to advance training ‘in the field’.

Strict adherence to standardized procedures is critical in any successful study. So as a primary requirement for participation in all trials, we insist that our site staff members undergo GCP training. The Site Managers guarantee that research is executed according to the GCP guidelines, federal regulations and institutional policies. The Managers monitor the status of each trial for patient recruitment, study the trial progress and oversee punctual reimbursement from study sponsors. OCT Site Managers are the direct connection from our office to investigators and site personnel.

The Network

15,000 physicians

2 Ivy League medical schools:

    Columbia University College of Physicians and Surgeons and the Joan and Sanford I. Weill Medical College of Cornell University

30+ university and community hospitals

70 hospital or community-based ambulatory care sites

Several single and multi-specialty physician practice groups

For investigators, private practice sites, primary and affiliated hospitals and our sponsors, OCT offers a full array of managerial services. Our administrative department excels in budgetary preparations and negotiations, contract execution, fiscal services and data management. We will identify and place trials into the network and manage accounts payable for the sponsors. No matter how many sites there are in a given study, there is one contract with OCT and one payment for the sponsor. And we understand the IRB approval process. Our close association with the Columbia Presbyterian and New York Weill Cornell Center Review Boards, as well as the IRBs at all our affiliated hospitals, has made it possible to ensure a rapid response.

CTN is a collective of people dedicated to investigative research and the ethical treatment of patients. Through OCT we have all the pieces in place to create tremendous opportunities for the advancement of medical science. We have already begun.

Recruiting for CABG Patch Trial

Serving Patients

  • participate in cutting-edge research from pharmaceutical industry, NIH and academic researchers
  • assurance that study researchers are trained in and adhere to Good Clinical Practices (GCP)
  • availability of new drugs and devices at no cost prior to their approval for marketing
  • study, review and approval in cooperation with local, not-for-profit, IRBs

Benefiting Private Physicians

  • centralized administration: OCT negotiates all contracts, budgets and arranges all site payments
  • CTN brings clinical trial opportunities to sites not otherwise available
  • co-investigate studies with academic ‘thought leaders’ and participate in professional publications
  • studies attract new patients and make available new therapies to existing patients
  • Clinical Site Managers provide on-going training and back-up for site personnel

Supporting Academic Investigators

  • opportunity to place Investigator-initiated research in Clinical Trials Network
  • participate in clinical trials as advisors, without obligation to enroll patients
  • enter the drug development cycle early, with greater input in study design
  • access to large pool of potential study subjects
  • promote clinical research conducted by non-profit organizations

Connecting Sponsors

  • large, diverse patient populations available through proven clinical research sites
  • speedy contract and budget negotiation leading to rapid study initiation
  • standardized training and quality assurance, ensuring highest quality research data
  • access to ‘thought leaders’ and intellectual resources at two major academic medical centers for consultation and protocol development
  • coordinated IRB review throughout Clinical Trials Network
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