Clinical Trial Design and Innovation

This service is provided by Biostatistics, Epidemiology, and Research Design (BERD).

Overview

The Irving Institute encourages all researchers at Columbia University Irving Medical Center (CUIMC) to take advantage of the clinical trials expertise in our group in adaptive clinical trial designs to provide guidance on the following:

• Clinical Trial Design for all phases of drug development
• Adaptive Trial Designs
• Protocol Development
• Clinical Trial Data Management
• Clinical Trial Data Coordination
• Clinical Trial Implementation and Conduct
• Clinical Trial Data Analysis and Manuscript Preparation

The statistical and data management team will collaborate with the investigators to decide on the most appropriate, innovative, and efficient design for the trial, participate in grant applications, protocol developments, data management and analysis plans, as well as, in the implementation, conduct, analysis, and publication of the trials. 

Starting in March 2020, we are also providing consultations for COVID-19 research. 

Eligibility

The Clinical Trial Design and Innovation resources are available to all faculty and officers of CUIMC. Students are not eligible for this service.

When to Request This Service

We encourage researchers to submit a request as early as possible and at least eight weeks before a grant is due.

Cost

• Initial consultations and limited follow-up are free of charge.
• With our consulting to collaboration model it is expected that the statistical and data management team will be included as collaborators on any grant applications as determined by the team. 

Cite it, Submit it, Share it!

If your research has benefited from one or more Irving Institute resources, please remember to:

• Cite our CTSA grant, UL1 TR001873, in any relevant publications, abstracts, chapters, and/or posters.
• Submit your publications to PubMed Central (PMC) for compliance with the NIH Public Access Policy.
• Share your research updates with us by sending an email to: irving_institute@cumc.columbia.edu