Plan COnDUCT

advertisement
Pl an
Study design • Sample size needs
Analyze pilot data
Proposal preparation
CON DUCT
Interim analyses • DSMB support
Monitoring
Analyze
Data QA/QC • Data analysis
Interpretation
UC Davis CTSC
Biostatistics
Pu blish
Manuscript preparation
Response to reviewers
Enhancing clinical and translational
research by providing statistical expertise
to investigators
Contact Us
For more information about biostatistical
services available through the CTSC contact:
Statistical consultation
Grant proposal preparation
Sandra Taylor, Ph.D.
Study design/protocol development
Senior Statistician
916-703-9171
Statistical analysis plan preparation
sltaylor@ucdavis.edu
www.ucdmc.ucdavis.edu/ctsc
Data analysis and interpretation
DSMB participation
or visit our website:
www.ucdmc.ucdavis.edu/ctsc/area/
biostatistics/index.html
The UC Davis CTSC is a member of the national CTSA consortium and
supported by award TR000002 from the National Institutes of Health’s
National Center for Advancing Translational Sciences. The Clinical and
Translational Science Awards (CTSA) is a registered trademark of DHHS.
www.ucdmc.ucdavis.edu/ctsc
Getting
Assistance
Services Offered
Weekly Biostatistics Office Hours
Overview
Study Design/Protocol Development
Successful investigators recognize the benefits of
including statisticians in their research projects.
Statisticians help ensure that the study design is
powerfully and cost-efficiently matched to study
objectives, that necessary data to address those
study objectives are collected, and that appropriate
statistical analyses are conducted and reported.
These conditions are vital for successful research.
Input on study design and protocol development,
including:
The CTSC Biostatistics group provides statistical
support for all phases of research from designing
the study and analyzing the data through
publishing the results. We serve a wide range of
clinical and translational researchers across
disciplines and all sizes and types of projects, from
simple data analyses to large, multi-center clinical
trials.
Biostatistical Consultation
Statistical advice on specific statistical issues or
preliminary discussion to determine the scope and
needs of a specific project.
Grant Proposal Preparation
Assistance with grant proposal preparation, including:
Refining study specific aims
Developing the study design
„„ Determining sample size requirements
„„ Preparing a statistical analysis plan
„„ Crafting proposal sections related to statistics
„„
„„
Determining study structure/approach
(e.g., two-arm study, case-control study)
„„ Defining control population
„„ Establishing randomization procedures
„„ Developing matching criteria and/or strata
„„ Specifying interim analysis procedures
„„ Conducting sample size calculations
„„
Statistical Analysis Planning
Consultation on appropriate statistical methods
for analyzing a data set to address the specific
aims of a study.
Data Analysis and Interpretation
Statistical analysis of data using state-of-the-art
methods and software. Our highly skilled
statisticians work closely with investigators to
understand their research objectives and conduct
appropriate and meaningful analyses.
DSMB Support
Biostatistician participation on the DSMB for
your clinical trial and conduct of statistical
assessments defined in the study protocol for
the DSMB.
Tuesday, 12 :00 – 1:30 p.m. at the CTSC
Receive input from a statistician about the design,
analysis or presentation of your medical research in
a friendly, informal setting. Reserve a time at
https://ctscbiostatisticsworkshop.acuityscheduling.
com/schedule.php
Request Services
Investigators can request more in-depth biostatistics assistance through the CTSC, and one of our
statisticians will be assigned to work with you individually. To request assistance go to www.ucdmc.
ucdavis.edu/ctsc/ and submit a request for services.
Investigators who only need statistical advice are
encouraged to attend the weekly office hours rather
than to submit a formal assistance request.
Rates for Services
The Biostatistics group is supported in part by funding from the CTSA NIH grant and the UC Davis
School of Medicine. This funding allows us to
provide some services without charge. Grant proposal preparation and analysis of preliminary data
in support of grant applications receive highest
priority for unfunded efforts. For other biostatistical
assistance (e.g., data analysis), unfunded support is
limited to 10 hours. In all cases, projects supported
by extramural funding must provide salary cost
recovery for professional statistical services at a
level commensurate with the available funding and
level of effort.
Download