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What is a clinical trial?
A clinical trial is a planned experiment designed to
assess the efficacy of a treatment in humans by comparing the outcomes
in a group of patients treated with the test treatment with those
observed in a comparable group of patients receiving a control
treatment, where patients in both groups are enrolled, treated, and
followed during the same time period.
What is the Clinical Trials Office?
Established in 1992, the Clinical Trials Office is the main
administrative arm of clinical research for the Columbia University
Medical Center at New York Presbyterian Hospital. Since its
inception, the CTO has negotiated over 1,600 contracts representing
over 500 sponsors.
Our mission is to:
- provide patient access to clinical trials
- support investigators in every aspect of protocol development,
contract execution, and trial maintenance
- serve as the contact point for industrial sponsors to access
sufficient numbers of patients in an efficient manner
What is the value of a clinical trials office?
The Clinical Trials Office is the center for coordinating
every aspect of clinical research, from contract negotiations
to budget solutions, from protocol development to protocol
maintenance. As such, this office provides the necessary tools
for conducting innovative and safe clinical testing in compliance
with required financial and regulatory guidelines.
The Clinical Trials Office ensures that our trials are in
accordance with the Food and Drug Administration's required
qualifications. More information about FDA required commitments
can be found at the FDA
Center for Drug Evaluation and Research Web site.
How does our Clinical Trials Office meet these required
qualifications?
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