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The GCRC Biostatistics Core members provide statistical consultation
and collaboration to GCRC investigators in all stages of the clinical
research process for approved protocols. The process starts with protocol
development and protocol review and continues throughout the conduct,
analysis, and reporting of results for GCRC approved protocols. The
members of the Biostatistics Core also serve as statistical members
of Data Safety Monitoring Boards for GCRC approved protocols.
Protocol Review:
Members of the GCRC Biostatistics Core are members of the GCRC Advisory Committee
(GAC) which meets monthly to review all submitted protocols. The Biostatistics
Core statisticians review each submitted protocol for clarity of the objectives,
appropriateness of study design to meet the stated objectives, sample size
and power considerations, data collection and management procedures, implementation
issues (e.g., randomization, potential for missing data, reproducibility and
validity of measurement tools, etc.) and plans for statistical analysis.
For each submitted protocol, a recommendation to approve, defer, or disapprove
the protocols is provided to the GAC. For those protocols that are deferred
or disapproved on the basis of the statistical review, the investigator is
provided with a written statistical review. If the protocol is considered by
the GAC to be scientifically acceptable, the investigator is invited to contact
the reviewing statistician to discuss the protocol. The statistician then collaborates
with the investigator to address the specific issues and to prepare the revisions
to the protocol including the statistical considerations sections of the study
for resubmission to the GAC.
Protocol Development:
Investigators who are planning to submit protocols to the GCRC are advised to
contact the Biostatistics Core during the protocol development stage. At this
stage, the Biostatistics Core provides collaboration for problem formulation
to ensure that the hypotheses are clear and provides guidance with respect
to the choices of study designs, sample size and power considerations, and
plans for implementation and statistical analysis. This process generally facilitates
the submission to the GCRC and subsequent scientific review and approval by
the GAC since many of the statistical and study design issues have already
been considered.
Statistical Analysis:
The Biostatistics Core provides consultation and limited collaboration for statistical
analysis of data from supported GCRC approved studies. The Core provides limited
consultation for the analysis of data from pilot studies that are supported
by the GCRC. In particular, in collaboration with the Functional Genomics Core
and Bioinformatics Core, statistical analysis of microarray data will be carried
out for supported, approved projects. The Core also provides consultation for
GCRC investigators to enable investigators to conduct complex data analysis
that includes identification of approaches to handling missing data, longitudinal
data, outlier detection, adjustments for multiplicity, and selection of appropriate
software for analysis, among other issues.
Grant Proposal Development:
Biostatistics Core statisticians also collaborate in the preparation of proposals
for peer reviewed funding by GCRC investigators. It is expected that the collaboration
of Core members in the development of funded research proposals leads to a
request for funding of the biostatistics collaboration through the grant mechanisms
at the appropriate level of support estimated by the Core Director.
Informatics Collaboration:
The Biostatistics Core members collaborate with the Informatics Core and the
investigator to provide guidance in the data collection, data management, and
data processing for GCRC approved protocols. This collaboration includes the
review of data collection forms and procedures. Drs. Goldberg and Belitskaya-Levy
are members of the Informatics Advisory Committee.
Functional Genomics:
The Biostatistics Core members also collaborate closely with the new Bioinformatics
Core, a component of the Informatics Core, and the new Functional Genomics
Core, a component of the Core Laboratory. Drs. Goldberg and Belitskaya-Levy
are members of the Functional Genomics Committee that oversees the Functional
Genomics activities and allocates resources to identified projects. Requests
for statistical analysis are reviewed and prioritized based on recommendations
from the GAC and the Functional Genomics Subcommittee based on estimated resource
requirements and priorities.
Training:
The Biostatistics Core provides training for GCRC investigators, fellows, house
staff and medical students, and other clinical research staff. The Biostatistics
Core investigators serve as a resource for the training of investigators in
the statistical concepts and methods used in the design of research studies
and the evaluation of results obtained from these studies.
Biostatistics Core faculty give four lectures on statistical concepts in
the GCRC Clinical Research Training Course each year. These lectures
are:
- Issues in Study Design (Goldberg)
- Descriptive Statistics and Inference (Belitskaya-Levy)
- Analysis of Continuous Data (Belitskaya-Levy)
- Analysis of Categorical Data (Belitskaya-Levy).
Introduction to Biostatistics (G48.2303) in the Department of Environmental
Health Sciences in GSAS is given each fall semester by faculty in the Division
of Biostatistics at NYUSOM. Advanced courses are also available through the
Division of Biostatistics Graduate Program in Biostatistics.
For more information, see the Biostatistics
Web Site
Contact: Division of Biostatistics Administrator
Tel: 212-263-0314
Email:
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