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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
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.
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.
Serving Patients
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participate in cutting-edge research from pharmaceutical
industry, NIH and academic researchers
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assurance that study researchers are trained in and adhere
to Good Clinical Practices (GCP)
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availability of new drugs and devices at no cost prior to
their approval for marketing
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study, review and approval in cooperation with local,
not-for-profit, IRBs
Benefiting Private Physicians
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centralized administration: OCT negotiates all contracts,
budgets and arranges all site payments
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CTN brings clinical trial opportunities to sites not otherwise
available
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co-investigate studies with academic ‘thought
leaders’ and participate in professional publications
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studies attract new patients and make available new
therapies to existing patients
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Clinical Site Managers provide on-going training and back-up
for site personnel
Supporting Academic Investigators
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opportunity to place Investigator-initiated research in
Clinical Trials Network
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participate in clinical trials as advisors, without
obligation to enroll patients
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enter the drug development cycle early, with greater input in study
design
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access to large pool of potential study subjects
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promote clinical research conducted by non-profit
organizations
Connecting Sponsors
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large, diverse patient populations available through proven
clinical research sites
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speedy contract and budget negotiation leading to rapid
study initiation
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standardized training and quality assurance, ensuring
highest quality research data
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access to ‘thought leaders’ and intellectual
resources at two major academic medical centers for consultation and
protocol development
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coordinated IRB review throughout Clinical Trials
Network
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