Title: CTSI newsletter
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Permanent Link: http://ufdc.ufl.edu/UF00090016/00007
 Material Information
Title: CTSI newsletter
Series Title: CTSI newsletter
Physical Description: Serial
Language: English
Creator: Clinical and Translational Science Institute, University of Florida
Publisher: Clinical and Translational Science Institute, University of Florida
Place of Publication: Gainesville, Fla.
Publication Date: February 2009
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Bibliographic ID: UF00090016
Volume ID: VID00007
Source Institution: University of Florida
Holding Location: University of Florida
Rights Management: All rights reserved by the source institution and holding location.


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From the Director

RDAP: Connecting
Investigators and
Methodologists to
Improve Health

Meet the RDAP

CTSI Seminar Series


Volume 2, Issue February 2009

Volume 2, Issue 1 February 2009

The CTSI Newsletter has returned from a brief hiatus after recovering from the
holidays and the excitement of yet another NCAA Championship. This month's
edition has two features of importance for all CTS investigators. The first is a
description of a key institute program: The Research Design and Analysis Program
(RDAP) headed by Keith Muller and Jon Shuster from the Division of Biostatistics in
the Department of Epidemiology and Health Policy Research. Drs. Muller and Shuster
and their colleagues have generated an outstanding resource for assisting faculty mem-
bers and trainees in the early stages of the design of clinical or translational research
studies, particularly as it relates to various alternatives in study designs (such as, for
clinical trials) and biostatistical considerations, data management and data analysis.
Use the RDAP resource early in the process of crafting your research protocol and
maximize your chance of developing a mature research plan that rigorously addresses
proper power analysis, randomization, blinding, etc. Don't let yourself be your most
confounding variable!

The second section of this Newsletter summarizes an important new means of
communicating additional CTSI resources to the Institute's community, researchers
and trainees. Chris Batich, Chief Operating Officer of the Institute, has spearheaded
the development of a lecture series designed to provide knowledge about cutting-
edge scientific and educational resources here and globally through four major CTSI
programs: Translational Technologies and Resources (directed by Jesse Gregory);
Training and Professional Development (directed by Marian Limacher); Community
Engagement and Research (directed by Betsy Shenkman) and Biomedical Informatics
(directed by Mike Conlon). I'll be kicking off this series on February 18 with an
overview of the CTSI, its goals and programs. Subsequently, we anticipate having a
weekly lecture on alternate topics provided by outstanding UF and outside speakers.
We actively encourage your input in suggesting speakers and topics for the lecture
series, so please contact Dr. Batich with your ideas.

Finally, don't forget that next month we will reissue the RFA for internal funding of
Pilot and Collaborative Projects. As always, our emphasis will be on stimulating new
multi-disciplinary and inter-disciplinary research, so start thinking creatively and
collaboratively. Good luck!

Peter W. Stacpoole, PhD, MD
Director, General Clinical Research Center
Director Clinical and Translational Science Institute
Associate Dean Clinical Research and Training

Clinical and Translational Science Institute University of Florida Gainesville, FL 352.273.8700

Volume 2, Issue 1 February 2009

R s ea ch Ds ig n A n yi s Pro ra m BY PA LARAe

Despite the complexity of putting its vision into
action, the idea behind the CTSI is simple:
The synergy generated by bringing together
researchers from different fields, colleges, depart-
ments, and institutes campuswide creates a host of
new possibilities that were previously unforeseen for
curing disease and providing better care to patients,
and bringing those advances to fruition more quickly.

CTSI "will be a point of contact and conduit to creat-
ing interdisciplinary teams to reach everything on the
NIH roadmap," said Keith Muller, Ph.D. Muller serves
as director of the CTSI Research Design and Analy-
sis Program (RDAP), which will be instrumental in
fulfilling the institute's mission.

Single point of reference
The Program has several goals, according to Muller
and co-director Jonathan Shuster, Ph.D. First and fore-
most, the program functions as a single point of con-
tact and support for investigators throughout UF using
both quantitative and qualitative research methods.
RDAP brings together for the first time methodolo-
gists from different disciplines, areas of expertise, and
colleges in order to provide coordinated and integrated
services that can assist researchers improve their CTS
research studies. In the past, despite significant exper-
tise universitywide, coordination was often lacking.
This created barriers to scientists seeking methodolog-
ical expertise and prevented experts from interacting
as a team to develop the best strategies for designing
studies and analyzing data gaps the Program will

Describing RDAP as "inclusive, eclectic, and ecumen-
ical," Muller calls it "a statistical yente a matchmak-

er," that brings together multi- and interdisciplinary
researchers and methodologists in order to better ad-
dress the complexities of CTS. This includes biostatis-
ticians; epidemiologists; and experts in health services
research, quality of life studies, focus groups, and
other methodologies who provide intellectual diversity
and a strong foundation for the Program.

Faculty experts with RDAP provide a variety of re-
search design guidance, including framing of hypothe-
ses, sample size selection and randomization, variable
specification and measurement, and implementation
of appropriate statistical methodologies for analyz-
ing data. RDAP also collaborates with other CTSI
programs, including the Community Engagement and
Research Program and the Biomedical Informatics
Program to carry out a host of tasks. These include
maintaining recruitment and tracking databases; moni-
toring participant accrual and retention; setting up sys-
tems for ongoing safety analysis; ensuring appropriate
database designs, and developing standardized forms,
web-based interfaces, and other data capture tools;
monitoring data collection and quality; and dissemi-
nating information about potential collaborators.

Methodological cooperation and
RDAP will focus on helping investigators develop
strong research teams. This will be accomplished by
linking investigators to potential methodology col-
laborators who are best suited to meet the demands of
their studies in terms of design and analysis and who
share an interest in the principal investigator's content

Clinical and Translational Science Institute University of Florida Gainesville, FL 352.265.273.8700

Volume 2, Issue 1 February 2009

Rsearc Deig alnd Anti Proram

The collaborations developed through the Program
will not only improve individual studies, but they also
can promote the development of new methodologies
through the discovery that comes from people work-
ing together, Muller said. Key advances will arise by
developing adaptive designs, which allow the features
of a study to be changed in a planned way while still
following a set of rules. This work stresses defining
adaptive methods that will be accurate in small sam-
ples, a constant statistical challenge and which many
RDAP experts' work has emphasized.

The Program's diverse functions will be self-sustaining,
supported primarily by fees, and portions of research
funding it receives when investigators write RDAP
services into their grants. Experts provide grant-writing
help at no cost to investigators who request in their pro-
posals funding to cover the Program's services.

Input from Colleges of Dentistry,
Liberal Arts & Sciences, Medicine,
Nursing, Pharmacy, Public Health
and Health Professions in Key
Disciplines of:



Health Services &
Outcomes -

Health Economics

Problem-solving partnerships
RDAP represents an advance not only with respect to
bringing together previously disparate methodologies
and researchers, it also provides a greater opportunity
to anticipate and manage potential issues before they
become unsolvable problems. In a worst-case scenar-
io, such problems could lead to data that is unusable
or cannot be analyzed. The technological innovations
of the past decades have significantly increased that
likelihood, according to Shuster. These innovations
have made once impossible data collection not only
possible, but relatively easy. However, the ability to
analyze the data once it is collected has lagged. Com-
plicating matters further is that it is not uncommon to
go through the time, effort, and expense to collect and
analyze data, but not to be able to separate the effects
of scientifically interesting variables from other vari-
ables known as confounders, making it impossible to
tease out the real cause of an outcome.

Output of
support provided to all
CTSI Investigators in
areas of:
Research Design
S Preclinical to
Community Trials


Data Analysis

Clinical and Translational Science Institute University of Florida Gainesville, FL 352.273.8700

Volume 2, Issue 1 February 2009

RserhDsg and Anyis Program:*

One simple example of this occurred when an investi-
gator wanted to show that pain scores improved four
months after an experimental intervention. The answer
was yes, but because the intervention involved an
acute condition, these data could not be used to infer
that it was the intervention, and not the natural healing
process or a combination of the two, that was respon-
sible for the patients' longer-term improvement.

Another instance occurred when an investigator got re-
sults close to significance after completing a trial with
an initial set of participants and asked for an extension
to accrue more patients. However, the investigators
had already spent their entire nickel and had no more
to extend the study. Had the investigators planned the
study differently, undertaking interim looks at reviews
of its efficacy at preplanned timing points, the study's
monies could have been spent at varying time points.
It was too late to do this after the fact.

These examples highlight the importance in getting
guidance from an appropriate methodology expert
early on so any potential issues can be worked out
before these problems arise, Shuster said. If a study is
planned well up front, it can be accomplished, Muller
said. "Small changes can make a big difference."

CTS-specific training
The Program also provides training courses specifi-
cally designed for researchers across the CTS con-
tinuum from preclinical studies to community engage-
ment. Several excellent programs exist for training
UF graduate students pursuing careers in statistics,
biostatistics, epidemiology, and health services re-
search. However, methods courses available to CTS
investigators are limited. As a result, a series of six-

week modules were developed for CTS researchers on
topics including research design, data acquisition and
management, and analysis concepts and techniques.

Muller and Shuster say they are excited about the
ability of the CTSI and RDAP to establish connections
between scientists in previously disparate research
areas because of the significant advances in research
that will result. More important are the improvements
in health care and people's health these interactions
can generate.

"I really think we're at the beginning of a revolution,"
Muller said.

Clinical and Translational Science Institute University of Florida Gainesville, FL 352.273.8700

II New slette

Volume 2, Issue 1 February 2009

Keith Muller, Ph.D. and Jonathan Shuster, Ph.D., will co-direct RDAP.

Keith Muller, Ph.D., is a professor and director of the Division of Biostatistics in the College of
Medicine's Department of Epidemiology and Health Policy Research. He came to UF after 28 years
in Biostatistics at the University of North Carolina, where he is an Emeritus Professor. Muller also
provides design and analysis review as part of the internal preparation process for research grants at
the Malcom Randall Veterans Administration Medical Center. In addition to serving as RDAP director,
he functions as its primary mentor for faculty teaching the applied biostatistics and selected methods
courses, and chairs its Laboratory and Translational Science Subcommittee, which conducts initial
review of all laboratory-based, preclinical and Phase 1 clinical trial proposals.

Muller's research centers on developing more efficient designs and methods for selecting sample size in study planning, espe-
cially for medical imaging research, and he has been working to develop novel methodologies in this area. Muller's work has
emphasized developing methods accurate in small samples, and he has been a leading contributor to the theory and practice of
adaptive designs, with internal pilot designs as a special case. He has co-authored three textbooks on linear models, the most
widely used statistical methods. The latest text provides the first fully integrated treatment of the univariate, multivariate and
mixed linear models, an approach that provides access to many small sample properties for special mixed model classes that
would not be available otherwise, including better estimation, inference, and sample size selection. Contact: Keith.Muller@

Jonathan Shuster, Ph.D., is a research professor in the Department of Epidemiology and Health
Policy Research, and the biostatistician for UF's General Clinical Research Center (GCRC). A mem-
ber of the UF faculty since 1969, Shuster is internationally recognized for his work in clinical trials
and translational science, has nearly 300 peer reviewed publications, and has been awarded more than
$30 million in grants from the NIH and other federal agencies as a principal investigator or co-PI. In
October 2008, he completed a four-year term as a member of the Cardiovascular and Sleep Epidemiol-
ogy Study Section for the NIH, his fifth term on an Institute study section. He also is a member of the
Editorial Board of the journal SequentialAnalysis. In addition to serving as RDAP's co-director, Shus-
ter chairs its Clinical Research Subcommittee, which conducts initial review of all mechanism-based,
patient-oriented research and Phase 2 and 3 proposals.

Shuster's expertise is in group sequential designs for clinical trials, sample size determination, clinical epidemiology, and
meta-analysis. He has written a suite of study design programs that have been made widely available to biostatisticians. He
has made important contributions to estimating statistical power for re-randomization tests and exact inference, which is vital
in clinical and translational research projects having small to moderate sample sizes. His numerous successes have resulted
in him being recognized by peer reviewers as "an active developer of statistical methods to handle unconventional needs or
measures." His reviews of externally funded multicenter GCRC studies that have been presented to the UF GCRC Advisory
Committee (including major NIH peer-reviewed studies and pharmaceutical trials) have resulted in numerous design changes
at the central office for these external studies. One example was a study to prevent maternal transmission of HIV to their
babies, a three-arm trial of 3,000 mothers nationwide in which the safety monitoring plan underwent a major change resulting
from Shuster's redesign of the study. Contact: jshuster @biostat.ufl.edu

Clinical and Translational Science Institute University of Florida Gainesville, FL 352.273.8700 5

II New slette

Volume 2, Issue 1 February 2009

Chris Batich, Ph.D.
CTSI Chief Operations Officer
One of the key parts of the CTSA now being reviewed by NIH is the establishment of a regular CTSI
seminar to bring in outstanding outside speakers to UF and to use talks by our own excellent speak-
ers to learn about each other's work. With that goal in mind, we have organized a seminar series that
will highlight a different one of the four key components of the CTSI once each month. The four
groups are: Community Engagement (CE), Translational Technologies (TT), Biomedical Informat-
ics (BMI) and Professional Development or Training (PD). For this semester, we plan to have a talk
each week in room LG 110A/B (in the McKnight Brain Institute) from 9-10:30 a.m. (to allow time for discussion).

Our Director, Dr. Peter Stacpoole, will present an overview of the new opportunities and ambitious goals for the CTSI at
our first talk set for February 18. This will be followed by a talk by Dr. Hartmut Derendorf on "Modeling and Simulation
to Streamline Drug Development" as the first TT talk. The next week, we will have a BMI talk, followed by a PD talk
and then a CE talk. This pattern will roughly repeat through the semester (skipping Spring Break), and begin again in the
Fall Semester. We plan to video record the talks, and to provide them as an archive on the CTSI web site. Some of the
talks will be linked to a distant audience as a webinar. Individual announcements will also be sent before each talk, and
they will be announced in the newsletters. We welcome suggestions for potential speakers or topics.

Did you know that there are multiple venues through which both internal and external jobs are posted?

For Job Seekers
https://jobs.ufl.edu University of Florida jobs postings.
http://www.union.ufl.edu/jobs/ Reitz Union student job listings.
http://www.sfa.ufl.edu/programs/workstudy Federal Work-Study Program.
http://www.sfa.ufl.edu/programs/ops.html Other Personnel Services jobs.
http://www.sfa.ufl.edu/programs/oce.html Off-Campus jobs.
http://www.sfa.ufl.edu/programs/vaworkstudy.html Veteran's Affairs Work-Study.

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