GCRC Biostatistical Resources
Overview
Georgetown's General Clinical Research Center provides consulting services in the areas of study design and biostatistics for clinical investigators at Georgetown and throughout the MedStar system. The Biostatistics Core endeavors to facilitate the flow of clinical research through the GCRC and to encourage and enhance research activities by providing high quality statistical support to GCRC investigators.
GCRC Biostatistical Staff
Nawar
Shara, PhD, is the Director of Georgetown's GCRC Biostatistics Core.
Dr. Shara and other consulting biostatisticians are readily available
for consultation on development of GCRC protocols. Investigators
are encouraged to utilize the GCRC Biostatistics Core in planning
their research activities.
How to access GCRC Biostatistical Support:
Investigators
seeking study design or biostatistics support for GCRC- related
activities are encouraged to contact the biostatistical staff at
Biostatistics@MedStar.net
as early as possible in the design of new research activities.
Email is a convenient method to establish contact with the GCRC
Biostatistics Core. The consulting biostatisticians can also be
reached by phone at 202.444.8748 at the Biostatistics Core office
which is located on the GCRC unit. Telephone consultations are useful
in securing the exchange of critical information between investigators
and Biostatics Core Staff. In-person meetings are also available
and can be arranged onsite at the GCRC unit once protocol development
is underway.
GCRC Biostatistics Core Services:
The GCRC Biostatistics Core staff provides statistical consultation and collaboration for GCRC investigators in all stages of the clinical research process. Services provided by the GCRC Biostatistics Core fall in 4 general categories:
1. Provision of statistical consultation during the development
of protocols that will be conducted at the GCRC.
Investigators
who are planning to submit protocols to the GCRC are advised to
contact the Biostatistics Core early in the protocol development
stage. At this stage, the Biostatistics Core provides collaboration
for problem formulation to ensure that study hypotheses are clear
and testable. The Biostatistics Core also provides consultation
on appropriate study design, the tradeoff between sample size and
power, and planning for study implementation and statistical analysis.
Consulting with the GCRC Biostatistics Core prior to protocol submission
to the GCRC Advisory Committee (GAC) often facilitates the scientific
review and approval by the GAC since many of the statistical and
study design issues discussed during protocol evaluation will have
been addressed by the investigator prior to submission.
2. Provision of statistical reviews for protocols that are being
considered by the GAC for support with GCRC resources.
GCRC
Biostatistics Core staff are also members of the GAC, which meets
monthly to review all submitted protocols. Biostatistics Core statisticians
review each submitted protocol for clarity of purpose, appropriateness
of study design, sample size and power considerations, data collection
and data management strategies, implementation (e.g., randomization,
handling of missing data, reproducibility and validity of measurement
tools) and plans for data analysis. Each protocol submitted to the
GAC receives a recommendation to approve, defer, or disapprove.
The statistical review is one aspect of this recommendation. 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 and move the
project forward. 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.
A simple web-based sample size/power calculation tool can be found
at the following link: http://calculators.stat.ucla.edu/powercalc/.
GCRC Biostatistics Core staff encourages investigators seeking sample
size/power consultation to visit this website and become familiar
with its content prior to discussing sample size calculations with
the Biostatistics Core.
3. Provision of statistical analysis and assistance with manuscript
preparation for completed GCRC protocols.
The Biostatistics
Core provides consultation and limited support for statistical analysis
of data collected from GCRC approved studies. The Core also provides
limited consultation for the analysis of data from pilot studies
that are supported by the GCRC. At times when analytic support is
not available, the Biostatistics Core can refer investigators to
additional resources for data analysis that are available on a fee-for-service
basis.
4. Provision of educational materials and interactions/opportunities
to improve the quality and interpretability of research conducted
at the GCRC.
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.
Nawar
Shara, PhD
Director of Biostatistics Core
nawar.shara@medstar.net
Tel: 301.560.7314 |
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