Mission Statement
The Division of Biostatistics was formed in order to provide leadership in the design,data
management, and statistical analysis of clinical, laboratory and epidemiologic studies
for the School of Medicine. This mission has been extended to include other schools
working in the health sciences including the Schools of Nursing and Dentistry. The
total mission is carried out through teaching, research, and service activities
related to biostatistics.
The biostatisticians and data managers of the Division of Biostatistics play a collaborative
role in the research studies in which they participate. As true collaborators their
main goal is the successful completion of each project. Ideally, this role begins
when the idea for the research project begins to take shape. The biostatisticians
can then have immediate input on the optimal
study design. An efficient experimental design can save money, time and
subjects (animal or people).
Sample size/power calculations early in the process can lead to an efficient
design and eliminate study hypotheses for which meaningful results cannot be obtained
within the constraints of the available sample. The study design also leads directly
to a preliminary statistical analysis
plan drafted by the biostatistician. The design stage of the study is also the appropriate
time for the data managers to begin to collaborate on the creation of the data collection
forms and to devise the appropriate
data management plan.
When the study begins, finalizing the data collection forms and sorting out the
details of the protocol are the first priority. The second priority is creating
the study database management system.
The database will mirror the collection forms and often include additional tables
to be used by the research laboratories. They also form a part of the comprehensive
data collection and management system that can include data entry via multiple methods,
quality control,
report generation and even randomization and subject scheduling. This type
of complete data system is crafted to fit the needs of each individual study and
to minimize data collection and entry as well as protocol violations. Timely report
generation is also a key component for tracking the progress of the study and keeping
the principal investigator and other personnel updated on any problems or concerns.
The statistical analysis of
research data is the task most closely associated with biostatisticians. In the
current environment where statistical analysis software is readily available to
all and easily implemented by anyone, the ability to run t-tests and regression
analyses is not a major contribution. However, current research in the health sciences
often involves the generation of data from study designs that violate many of the
assumptions of traditional statistical analysis. Correlated data from longitudinal
and clustered study designs are commonplace. Missing data patterns must be carefully
scrutinized before an appropriate data analysis method can be chosen. Huge amounts
of data are now routinely generated with new tools in areas like bioinformatics
and genomics. Observational studies based on huge clinical or claims databases must
correct for inherent biases. An understanding of the requirements for the traditional
methods and current knowledge of new areas of statistical analysis is required in
research to compete for funding and to publish results of completed studies. New
computationally intensive methods are often needed when assumptions are violated.
Only a professionally trained biostatistician can evaluate these issues, choose
a correct technique and even devlop new methodology to handle specific problems
in a research project.
Methodological development may be extensive and require the biostatistician to obtain
additional funding as PI of his or her own grant or it may require a smaller extension
of existing methods that can be developed within the initial analysis. In either
case, it will improve the analysis and maximize the information obtained from the
study data. A strong methodological publication record is a key component in many
new areas of research.
Biostatistics also plays an important role in preparing study results for both presentations
and papers. Concise presentations of descriptive and inferential results using graphs
and tables are part of our training. After all, a graph is worth a thousand words,
and a key statistic is worth at least a thousand data points. The biostatistician
also contributes the statistical methods section and often is a key player in the
interpretation of the results. Authorship
for members of the biostatistics team should be based on the accepted criteria of
most journals. These criteria generally cite both study design and statistical analysis
as intellectual input sufficient for authorship. Monetary support, either as salary
support on grants or reimbursement for time, does not preclude or replace authorship.
For a comprehensive review of HIPAA regulations and how they affect research on
this campus, please refer to
http://www.iupui.edu/~resgrad/hipaa/hipaa_menu.htm. Although the primary
investigator is ultimately responsible for ensuring HIPAA compliance, the Division
of Biostatistics plays an integral role in the proper storage and use of PHI. Our
data management experts are here to help you with ideas for data collection systems
and transfer. In addition, all staff members have received basic HIPAA training
and can help you identify problem areas both at the
Grant/Protocol Development stage and once the project begins in the
Collaboration in the Research Process stage.
Often investigators would like to conduct analyses using data collected from studies
that have been closed (i.e. IRB approval has been terminated). These studies most
often will need to be re-opened before we can access the data. Please se
Conducting Analyses on Retrospective Data to determine whether or not your
study will need to be reopened.
It is absolutely essential that investigators include Biostatistics as early as
possible in the development process. This should be well before the grant/protocol
deadline to take full advantage of the available expertise in designing the study.
As R.A. Fisher noted way back in 1938, "To consult a statistician after an experiment
is finished is often merely asking him to conduct a post mortem examination. He
can perhaps say what the experiment died of."