CTSA U54 (RM-06-002) Application – Dan Byrne’s additions (revised 12/21/05)
Timeframe:
Feb 27, 2006
March 27, 2006
Sept 2006
– Letter of Intent
– Application due
- Funding
Outline of the grant:
I) Overall Integrated Approach and Governance
25 pages
G. Bernard/D. Robertson
II. Program Functions
1) Development of Novel Clinical and Translational Methodologies
15 pages
Group
2) Pilot and Collaborative Translational and Clinical Studies
15 pages
G. Bernard/D. Robertson
3) Biomedical Informatics
15 pages
D. Masys/P. Harris
4) Design, Biostatistics and Clinical Research Ethics
15 pages
F. Harrell/D. Byrne
a) support provided
b) resources available
c) approaches to prioritize research topics or projects
d) educational topics
e) chargeback systems
F. Harrell/J. Manning
f) integration of clinical research ethics
L. Churchill
5) Participant and Clinical Interactions Resources (PCIR)
15 pages
D. Robertson/L. Lane
6) Community Engagement
15 pages
TBD
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7) Translational Technologies and Resources
15 pages
TBD
8) Research Education, Training and Career Development
25 pages
N. Brown/others
9) Public health Implementation and Evaluation
10 pages
B. Dittus
10) Research Initiation and Conduct Administrative Support
10 pages
J. Pulley
11) Other program function (?)
10 pages
TBD
12) Other program function (?)
10 pages
TBD
III. Evaluation and Tracking
20 pages
G. Bernard/D. Robertson/R. Chalkley/team
IV. Implementation Phase and Milestones
10 pages
L. Lane/G. Perez/T. Yarbrough/team
V. Tables
50 pages
L. Lane/G. Perez/T. Yarbrough/team
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Current draft of section II-4
Design, Biostatistics and Clinical Research Ethics
15 pages, F. Harrell/D. Byrne
Overall Vision, Approach, and Goals (1 page)
Although Vanderbilt is widely regarded as a leader in clinical research, the CTSA will
provide valuable resources to enable research that is more efficient and addresses specific
concerns of the American public. These resources will also provide support for research
and improvements in advanced experimental designs, such as adaptive designs, which
can significantly raise the level of clinical research ethics.
Like many General Clinical Research Centers (GCRCs), Vanderbilt’s GCRC has
traditionally been hindered by an outdated model with a disproportionately small amount
of biostatistical support. Over the past decade, this has grown into a rate-limiting step in
the research process. To correct this problem, we propose a Clinical & Translational
Biostatistical Core of 5 FTEs of biostatistical support and 1 FTE of administrative
assistant support. We will recruit 4 additional, experienced, applied biostatisticians, who
will have faculty appointments in the Department of Biostatistics but will focus their
efforts on functioning as catalysts in clinical and translational research in the capacity of
study design planning, research into efficient designs and analysis, analysis, consultation,
and teaching.
This additional support will enable the biostatisticians to apply modern, efficient study
designs that will not only improve the efficiency of the research but also create an
environment in which the research is conducted at the highest ethical level possible – in
that the question is answered while placing the fewest participate at risk. This support
will also allow us to implement and teach advanced statistical methods using modern
statistical software.
A major problem in modern medical research is that often the research is not reproducible
and the results are often overstated. The Department of Biostatistics is a leader in the
area of reproducible research and reproducible reporting. Another common problem
regarding biostatistics in clinical research is poor communication and inadequate teaching
of biostatistics. Vanderbilt has been a leader at improving the quality of teaching of
biostatistics and has several innovations, such as a project to measure and improve longterm retention of statistical skills. The CTSA will support a major expansion of the
teaching activities to help fellows and investigators learn modern methods of analysis.
The Department of Biostatistics is currently developing an innovative Masters and PhD
training program in biostatistics that will emphasize experimental design, and state-ofthe-art statistical analysis and software. Since this program is not limited by tradition or
resistance of current faculty, it will fit ideally into the innovative CTSA model.
Vanderbilt has a novel Biostatistical Collaboration plan in which biostatisticians develop
long-term relationships with investigators in a discipline and become co-investigators.
The biostatisticians in the CTBC will complement this arrangement and provide
continuity to the translational research teams as they move the discoveries from bench to
bedside and then to the community. For more on the Department of Biostatistics at
Vanderbilt see: http://biostat.mc.vanderbilt.edu/twiki/bin/view
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Background/Situation Assessment (2 pages)
Vanderbilt has a long history of translational research. In fact, the building in which the
GCRC currently resides was specifically designed to foster collaboration between basic
scientist, clinical scientists, medical students, and clinicians. In many respects,
Vanderbilt has been moving in the direction described in the CTSA request for some
time. This funding will help increase the rate of this transformation.
Currently, there are numerous barriers for translational research, including:
Physical
Financial, budgets
Different goals
Different languages
Current GCRC guidelines
Current funding of NIH grants
Cultural
Administrative
Artificial
We proposed the following solutions to dissolve these barriers:
Establish a match-making mechanism (Clinical & Translational Think Tank) to
include a basic scientist as a co-investigator on every GCRC protocol.
Encourage clinical investigators and basic scientists to collaborate and co-author
papers with one another.
Invite basic scientist as speakers and attendees at clinical grand rounds.
Develop interdisciplinary translational research teams.
Support continuous quality improvement projects addressing novel ways to
reduce these barriers.
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Existing Services, Programs, and Resources (3-4 pages)
Vanderbilt’s GCRC Biostatistics Clinic.
Biostatistics Clinic is an innovative educational service that Vanderbilt’s GCRC
biostatisticians provide to clinical researchers and fellows. The Clinic has been offered
every Thursday from noon until 1 PM for the past two years. The purpose is to provide a
free, drop-in forum in which investigators, their fellows, or medical students can bring
data for statistical analysis or questions about analysis, study design, graphics, etc. A free
lunch is offered to encourage attendance.
Each week between 10 and 15 people attend. The GCRC biostatisticians lead the clinic
by demonstrating how to analyze the data using statistical software projected on a large
screen in the GCRC conference room. Participants learn practical skills regarding how to
set up a spreadsheet for analysis, how to screen data for errors, how to perform
descriptive and inferential analyses, and how to conduct modern, state-of-the-art
modeling. These clinics are also valuable in teaching fellows how to convert the analysis
into graphs, tables, and text suitable for publication in a medical journal.
On a typical week 2-3 participants will bring data or questions. The biostatistician uses
the examples to teach practical aspects of data analysis and also demonstrate how to
avoid common problems. These sessions provide a method of raising the level of
statistical skills so that investigators add more modern statistical tools to their toolbox
without having to enroll in a graduate course.
Biostatistics Clinic has been so successful that the Department of Biostatistics at
Vanderbilt has embraced the ideas and offers similar clinics during the noon hour on the
other 4 weekdays. See the following web site for details:
http://biostat.mc.vanderbilt.edu/twiki/bin/view/Main/Clinics
[The following will be described in more detail in the next draft.]
GCRC Research Skills Workshop
Research efficacy.
Efficacy of teaching.
GCRC Data Analysis and Publication Seminar Series.
Continuing Education.
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Development of Novel Programs and Functions (4-6 pages)
The 6 Key Novel Programs are:
1- Clinical & Translational Biostatistics Core
2- Clinical & Translational Research Teams
3- Think Tank for Clinical & Translational Research.
4- Publication Core
5- Research Nurse Training Program
6- Advanced Degree Program in Biostatistics.
1- Clinical & Translational Biostatistics Core (CTBC)
[Use subheadings for each novel approach that will transform scientific innovation into
health gains for the nation.]
The CTSA will solve the rate-limiting step in the current GCRC structure by expanding
the biostatistical support. We will develop a new Clinical & Translational Biostatistical
Core with 5 FTEs of biostatistical support. The GCRC currently has 1 FTE (2
biostatisticians at 0.5 FTE support). Four full-time, experienced applied biostatisticians
will be recruited.
This support will be used to provide additional biostatistical training and in-depth
analysis and study design consultation to investigators and the expanded network of
translational research teams. The current underfunding of biostatistical support creates
several problems. Without proper biostatistical assistance many protocols are never
translated into publications and many are published in less prestigious journals than the
importance of the findings indicate. In addition, many protocols could produce more
than one publication, if there was sufficient biostatistical support.
Experienced biostatisticians understand that minimizing bias and strengthening study
design are much more important than complex statistical methods. This expanded
support will provide resources and time to invest in planning research. It will also allow
the biostatisticians time to develop study designs and analysis plans for studies of unique
populations or very small numbers of subjects.
These biostatisticians will study what works and what does not work by comparing
protocols that are published with those that are not published (cold protocols) and
evaluating the impact of these publications on the practice of medicine in the community.
Resources will be devoted to measure return on investment and assessing productivity.
Biostatisticians will study, teach, and implement more efficient study designs. One task
will involve review of approved protocols over the past 5-10 years to assess the success
and obstacles. The accuracy of sample size estimates will be analyzed. This information
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will provide value in planning future projects. Thus, there will be a feedback loop to
apply what is learned about clinical research efficiency.
The CTSA will also provide biostatistical support to basic researchers. Many basic
researchers continue to use primitive, and often inappropriate, statistical methods wasting
valuable information from their experiments. While advanced statistics have not been
required for success in publishing in the basic sciences, this is changing rapidly. The
editor of Nature Medicine (ref x) recently wrote an editorial describing steps he was
taking to raise the level of statistical sophistication. This came after a review of papers
published in his journal found an alarming number of statistical flaws.
The CTBC will develop a high-tech data analysis conference rooms for a
multidisciplinary team of investigators to analyze and visual research data with state-ofthe-art graphical, statistical, and informatics tools. This room will also be used for
“extreme collaboration” in which the biostatistician analyze data during the meeting with
investigators to provide for efficient analysis. This avoids the common problem of long
delays at each point in the analysis when the biostatistician or investigator have questions
that must be answered. These rooms will resemble a “situation room” will multiple large
screens and a central conference table to provide real-time answers to questions.
The CTBC would also provide 1 FTE of administrative assistant support. This will allow
the biostatisticians to be productive by having an assistant help with routine tasks.
The biostatisticians from the CTBC will also provide support to Vanderbilt’s Institutional
Review Board on a rotating basis. The purpose of this assignment will be to continuously
raise the level of sophistication of investigators with respect to efficient study designs and
analyses to ensure the highest level of ethical research.
[Justification for the 5 FTEs will be added here]
The CTBC will establish a standing DSMB (0.5 FTE) in the Center. This will give
investigators ready access to such a panel when the GAC deems it necessary. It will
ensure proper and ethical conduct of clinical trials. Statisticians can play a role in this
effort.
With the added resource (5 FTEs) in biostatistics, it would make it possible for
statisticians to developed novel statistical methods, e.g. adaptive study design, for studies
with non-conventional design and analyses. That would enhance professional
development for statisticians in the Center, as well as helping investigators.
The biostatisticians will research methods of increasing the pace at which scientific
discoveries are translated into practical solutions that benefit patients. The value of
various endpoints, for example tumor size vs. survival time, will be evaluated. The goal
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will be increase the advances in the development process, the study designs, and analysis
to keep pace with the advances in science.
Novel Approach 10 – Research and apply the most efficient statistical tools. Clinical
research questions can often be answered more efficiently, with fewer patients by
applying statistical tools that they may not initially consider. The additional biostatistical
support will help investigators in this area. For example, many investigators fail to use
survival analysis in research evaluating time to event, when the event is something other
than death. Yet, these methods provide such increased efficiency that the question can
often be answer with a fraction of the patients required for methods that do not consider
censoring.
Novel Approach 11 – Integrate the biostatistical core, bioinformatics, and bench-tobedside laboratories to promote study design innovation.
Novel Approach 12 – Train investigators and research nurses how to create clean,
complete, and accurate spreadsheets and databases for optimal analysis. Clinical
and translational research could be greatly improved by training those who enter data
how to format the data set for statistical analysis. Much time is wasted by having to clean
and reformat data that was entered improperly. This will require integration with the
bioinformatics core and training at the appropriate point.
Budget money to pay a recruiter to find experienced applied biostatisticians who are
excellent communicators.
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2- Clinical & Translational Research Teams (CTRT)
Although the GCRCs have been highly effective at helping investigators address specific
clinical research problems, the rules and structure imposed on GCRCs have not
encouraged research with broader aims. The CTSA will allow us to restructure and
expand resources to address problems that are important to taxpayers and require this
broader perspective.
For example, taxpayers are concerned about the medication errors that occur during
hospitalization. An important component of our CTSA will be Translational Research
Teams designed to address such problems. In the first year, we will develop 5-10 such
teams. One team will study ways to reduce medication errors and adverse drug events in
the Vanderbilt Hospital. The CTSA award will allow us to form a team of pharmacists,
clinical pharmacologists, biostatisticians, informatics specialists, continuous quality
improvement experts, safety experts, and hospital administrators. This translational
research team (CTRT) will develop improve methods of tracking these events and assess
patterns and trends. The team will develop interventions to avoid ADE and track the
effectiveness of these interventions. Vanderbilt has already invested extensively in this
project, however, the CTSA and TRT will ensure that there are sufficient resources for
success.
See Figure 1.
Table 1. Thematic Areas for Clinical & Translational Research Teams.
Reducing Medication Errors and Adverse Reactions.
Improving Safety and Ethics in Clinical Research
Assessing Alternative Medicine and Treatments.
Issues in diseases with limited treatment options.
DNA databank
Assessing long-term safety of most commonly used prescription medications.
In addition, there will be teams focusing on the following leading health indicators:
Physical Activity
Overweight and Obesity
Tobacco Use
Substance Abuse
Responsible Sexual Behavior
Mental Health
Injury and Violence
Environmental Quality
Immunization
Access to Health Care.
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We will devote sufficient funding to address the translational research needs of the
community. For example, pharmaceutical firms often stop researching a treatment once
approved. Translational research would provide long-term safety information on the
most commonly used drugs.
In addition, many Americans use alternative medicines or treatments that are untested or
tested under biased conditions. Fair, unbiased research on the most commonly used
alternative medicines would be an important application of translational research.
[The following are suggestions for additions to this section.]
Novel creative programs. Innovative and creative research programs.
Limiting Risk to Study Participants:
[Reference H. Murff’s work here.]
Informed consent – testing whether participants actually understand.
Good example of translational research is reducing ADE. Also, good example of the
need to improve the quality of data and speed of converting the data into useful
information. Need for dashboard, control charts, etc. Need to invest in biomedical
informatics in this area and cross-train in biostatistics and quality improvement methods.
Develop an admission predictive modeling computer system to alter the hospital staff to
the probability of complications and ADE. Improving the hospital quality indicators will
require coordinated efforts and applied translational research.
Develop and study prevention strategies.
Pilot translational projects.
“catalyze the development of a new discipline of clinical and translational science.”
Clinical Research Ethics
How we will bridge these areas with other CTSA activities.
“encourage the development of novel methods and approaches to clinical and
translational research”
“partnerships in the CTSA are strongly encouraged between schools of medicine,
dentistry, nursing, pharmacology, osteopathy, public health, engineering, and other
clinically related institutions and clinical research entities.”
One of the Clinical & Translational Research Teams will be devoted to preparing for
efficient research of the next epidemic or sudden major health problem facing our
country. Approximately 5% of the CTSA budget will be reserved for this project.
A metric that will be used to assess this core is the percent of projects that address one of
the Health People 2010 goals.
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3- Think Tank for Clinical & Translational Research.
This program will have 2 primary functions:
1) Adding a translational aspect to GCRC Projects before GAC
2) Serve as an incubator for innovative research tools and information
technologies.
For each GCRC protocol, we will require three additional collaborators: 1) a basic
scientist, 2) a practicing physician/translational scientist, and 3) a medical student in the
Emphasis program. We will also help new fellows by matching them up with
investigators that have unexplored data.
Before projects go to the GCRC GAC, they are reviewed by this team, which provide
consultation on including a translational aspect to the project. There will be support for
protocol preparation, IRB issues, and data management. This team will also advise
investigators on additional biomarkers that might be added to the project.
Researchers will also be encouraged to create comprehensive registries to capture
appropriate data rather than simplistic spreadsheets of a single predictor variable and a
single outcome variable. Investigators will be encourages, taught, and supported in
collecting a vast array of biomarkers on research participants and hospital patients with
certain conditions.
The Think Tank will also be used to link to other GCRCs, CDC, and industry. Efforts
will be made to synergize partnerships with industry, foundations, and community
physicians.
This think tank will be used to improve the translation of information in both directions –
not only from basic science to clinical science but also from clinical science to basic
science. It will also work to improve the flow of information in both directions between
clinical science and the community.
Clinical scientists have much to learn from basic scientists regarding reproducibility and
enhanced scientific method. Basic scientists have skills and knowledge in optimizing
scientific process design that would be useful to apply in clinical science. Likewise,
basic scientists have strengths that they can share with basic scientists. Vanderbilt has an
excellent culture of cooperation. The Think Tank will be the catalyst to reduce barriers to
future cooperation to enhance translation research.
Investigators will be encouraged to demonstrate how their research supports progress
toward the Healthy People 2010 goals.
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4- Publication Core
Although Vanderbilt’s GCRC has long been considered one of the most productive with
respect to publication of medical journal articles, the CTSA will allow us to significantly
improve publication impact and productivity. This will be accomplished by creating a
Publication Core, which will be a catalyst to help investigators publish results more
efficiently. In addition, this Core will help communicate findings to the general public.
The core will support 3-5 medical writers, editors, and graphic artist. These will be
recruited from medical journals or from the American Medical Writers Association.
Another mission of the PC will be to translate the latest medical discoveries into a
general medical advice book for the lay public, similar to the Mayo Clinic health books
series (ref x).
This core would also be responsible for tracking and analyzing key metrics of the CTSA.
These would include:
Total number of publications related to CTSA support
Number of publications citing the CTSA grant number
Publications per protocol.
Total impact factor of these publications.
Total prestige factor (impact factor x circulation of journal)/1,000,000).
Time from approval of the protocol to publication.
Total dollars of NIH funding resulting from CTSA pilot projects.
Publications supporting the Health People 2010 goals.
Return on investment (cost/publication, cost/impact factor).
The publication core would build and maintain a modern web-based database of the
Vanderbilt research projects and publication metrics.
The publication core would also provide continuous quality improvement support to
assess factors related to publication and barriers to publication.
1. Offer a service of internal "study section" review of NIH grants.
Inform investigators that only 1/2 will be randomly selected to receive
this review, the others will be returned to the investigator who can
then work on it for another month.
2. Grants must be completed and submitted to your group 1 months prior
to the NIH deadline.
3. If the grant is not considered complete, it is returned without
consideration.
4. If the grant is considered complete, it is logged into a database.
The next envelope in the stack it opened which will determine whether
the grant receives the internal review or not. The envelopes contain
50% "review" and 50 "no review".
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5. Those that are randomized to review, are assigned to 4 Vanderbilt
reviewers who function as a study section. Each reviewer is paid $750
and must report in 1 week a 2 page report of recommendations for
strengthening the grant. These are similar pink sheets but provide
more detail about improving the grant. The 4 reviewers remain
anonymous. The reviewers are 1) subject matter expert, 2) medical
writer/editor, 3) very senior scientist, 4) an experienced
biostatistician.
5. At the end of the week the 4 reviewers meet to discuss the grant for
1 hour and compile a report that is sent from your office to the
investigator.
6. The investigator then spends the next 3 weeks making the changes and
strengthening the grant.
7. At the end of the year you evaluate the success rate of the 2
groups. The return on investment can be easily calculated.
8. If the program works, continue, otherwisee discard. Also, the
database would collect factors to assess factors associated with
success in funding. The database also contains feedback from
investigators on the value of various reviewers, so that money is not
spent on noneffective reviewers. Reviewers are only identified as
Reviewer #101, etc.
A similar program could be set up for investigators who want to submit
manuscripts to the New England Journal of Medicine.
First your group would evaluate whether the ms is reasonable to submit
there. If so, randomize and evaluation the ROI.
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5- Research Nurse Training Program.
Provide additional support and training for research nurses to allow for career growth.
An MS and PhD program in research nursing could be developed.
Partner with the nursing school to develop this training.
GCRC nurses will receive ongoing training and be involved in translating findings of
research into the community.
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6- Advanced Degree Program in Biostatistics.
The Department of Biostatistics at Vanderbilt, although relatively young, has already
begun evidence-based biostatistics and innovative projects and initiatives in several
areas.
Promoting state-of-the-art statistical methods and software.
Implementing extreme collaboration
Biostatistics Clinic every weekday
Reproducible research
Reproducible reporting
Continuous Quality Improvement projects for department operations
Collaboration plan
Although Vanderbilt has excellent biostatistical training programs in the MSCI and MPH
programs, many investigators cannot afford the time or tuition to participate in these
programs. The Clinical & Translational Biostatistics Core will provide courses and
workshops to train these investigators in applied biostatistics.
Increase the training and investigation into stronger experimental designs, reproducible
research.
[Tatsuki Koyama can write a section on more efficient designs, such as two-stage
adaptive procedures. Developing design and analysis plans for studies of unique
populations or very small numbers of subjects.
http://biostat.mc.vanderbilt.edu/twiki/bin/view/Main/TatsukiKoyama]
[Reproducible reporting – Frank Harrell can write this section.]
Expand biostatistics training to 100 fellows per year using the GCRC Data Analysis and
Publishing Seminar format.
One initiative will explore the factors related to publication and time to publication. This
information will be useful in improving efficiency and prioritizing resources.
Minimizing bias – discuss the issues in healthier than average participants in the GCRC.
Expand the teaching of biostatistics and writing papers. Fund a course on how to teach
biostatistics to physician-scientists.
Provide training and coaches on continuous quality improvement methods.
Make the academic home of biostatistics training in the CTSA.
“improve training and mentoring to ensure that new investigators can navigate the
increasingly complex research system”
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Expand the successful MSCI program. Provide MSCI training to those who cannot take
courses in the current schedule.
The CTSA will provide support for students in the Biostatistics MS and PhD program to
work as research assistants providing data management and data analysis services to
investigators in with CTSA projects.
The CTSA will be the academic home of the new MS and PhD graduate programs in
Biostatistics. This will be a unique program that will provide training in applied
biostatistics, using modern methods and software. Having the CTSA as the academic
home will provide benefit to investigators, instructors, and students. One of the major
weaknesses of graduate training programs is biostatistics is a lack a experience with
actual data and study designs. The challenges of these will be useful as teaching
examples and student projects. As the biostatistician-faculty members research the
effectiveness of study designs and analytic methods, they will incorporate this knowledge
back into their teaching. The integration of the training program into the CTSA will
foster this feedback loop.
Many clinical investigators and biostatisticians fail to include modern statistical methods
into their work. In fact, we have found that there are large gaps in knowledge for
physician-scientists in the statistical methods that have moved into common usage in the
past 20 years. This is evidence that the curriculum of many MPH and other training
programs are in need of modernization.
To address the continuing education needs of biostatisticians, we propose a structured
approach to identifying and teaching the latest statistical methods.
Pyramid of biostatistical skills – See Figure 6.
MSCI 14/yr
Workshops
Clinics
Short Courses
All 2500/yr
A metric that will be used in assessing this core is the number of researchers that pass a
biostatistical literacy test.
List of Novel Courses that will be offered in the MS and PhD program in Biostatistics:
1. Experimental Design and Clinical Research Ethics.
2. Clinical Trials.
3. Teaching and Communicating Biostatistics Effectively
4. Reproducible Research and Reproducible Reporting.
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5. Introduction to R.
6. Regression Modeling Strategies.
The biostatistics training program will also consist of links to industry, WHO, NIH, and
the CDC. Internships in both directions will provide valuable training and experience.
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Management and Integration (1 page)
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Benefits of Plan (to Translational Research, Researchers, and/or the Research
Process) (1 page)
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Performance Measurement against Transformational Objectives (1-2 pages)
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a) support provided
b) resources available
c) approaches to prioritize research topics or projects
d) educational topics
e) chargeback systems
F. Harrell/J. Manning
f) integration of clinical research ethics
L. Churchill
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References:
1. FH book
2. DB book
3. WD book.
4. Teaching paper.
5. ADE paper.
6. Genetics Medicine paper. Nat Med. 2005 Jan;11(1):1.???
7. Murff H. General Clinical Research Center Staff Nurses Perceptions and Behaviors
Regarding Informed Consent: Results of a National Survey.
8. Murff H. Research Participant Safety and Systems Factors in General Clinical
Research Centers.
9. Zerhouni E. The NIH Roadmap. Science 2003;302:63-72.
10. Elias A. Zerhouni. Translational and Clinical Science — Time for a New Vision
Volume 353:1621-1623 October 13, 2005 Number 15
http://www.ncrr.nih.gov/clinicaldiscipline.asp
http://www.csueastbay.edu/JERHRE/
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Figure 1. Diagram of a Translational Research Team for Avian Flu Pandemic. Unlike
the slow R01 process, the TRT could quickly respond and transform into a SWAT-like
team to address an urgent problem.
Infectious Disease
Basic Science
Publication Core
Community
Translational Research Team
Informatics
Biostatistics
Epidemiology
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Figure 2. The 2 bottlenecks will be removed.
Bench
Bedside
Trenches (practice)
CTSA
Community
Figure 3.
Basic Science
Figure 4.
Bench
Bedside
---------GCRC----
------------------------------------CTSA------------------------------------------------
Figure 5. Increase in GCRC Publications.
Figure 6 – pyramid of biostatistical skills.
Figure 7 –
scientific innovations
Transforming novel approaches
health gains
for the nation
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Appendix:
Questions to answer:
Will CTSA pay for instructor time, student tuition, or both?
Why is this proposal transforming?
Why is the implementation of biomedical discoveries so slow and so low?
What barriers between disciplines currently exist and how can they be lowered?
How can we be the catalyst of change?
How are we demonstrating significant institutional commitment?
Should we have a biostatistician on the IRB as part of the CTSA?
Do we want to have a statistician designated to the long-term drug
safety study team if we decide to have such a team in the Center? From
the Vioxx lesson, it seems this is an area that the industry, FDA, and
NIH did not pay enough attention, but it is of great importance to
public health. Maybe we can ask Wayne Ray and Patrick Arbogast to see if they want to
write a section on this. Vanderbilt is viewed without a
school of pharmacy and a school of public health, it might help to write about what we've
done in this area and what we plan to do in the future. Plus, every dollar spent on this
effort will get a lot back directly to the taxpayer.
The CTSA may provide an environment to expedite transfer of research
results from "a research setting" to the clinics, e.g. to promote
collaboration with the industry to move a new medication to the patients in a timely
manner. (To foster collaboration between the academic and the industry was mentioned
by the roadmap). Frank Harrell has been active with FDA and the industry and I can help
too if we decide to include a section on this. It may also help to include Oates Institute's
visions to emphasize this point.
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Jill’s comments:
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o There is some overlap with other areas (which is expected
and helpful to show the ideas everyone believes in). In one
instance, Lynn Hutchinson in the Office of Research is also
proposing a writing service, and my inclination would be to
incorporate the medical editing component that she can
provide (she was an editor of a pharmacology textbook) into
the broader service that Dan addresses (and wrote a book on!).
o The section overall is mainly about
*infrastructure/resources* and other support services which
is appropriate. But the RFA specifically says we are
"encouraged to develop innovative and creative research
programs" within biostats, which, might mean something else
needs to be added. i.e. are there limitations of current
methodologies or study designs which hinder translational
research, and which we need to address with exciting
biostats innovations? Just a thought.
o That notion might fit better in the "Development of Novel
Clinical and Translational Methodologies" function.
o An idea we have been working on is enbedding some "use
cases" throughout the proposal, which show how a new
research project would work its way through -- and be
improved by -- Vanderbilt's new system. Dan, you have some
topic areas for the development (e.g. "Reducing Medication
Errors and Adverse Reactions) for 'research teams" to focus
on... we might select one or two to blow out the use case
concept.
o Remember that in the CTSA world, there is no more GCRC!!
o I am very interested in your evaluation criteria, just curious.
o We all need to touch base with Larry Churchill regarding the
optimal incorporation of research ethics, which is required
as a part of this key function.
Jill Pulley’s comments:
>
* What types of support and resources will be in place to ensure
all
>
clinical and translational research designs are sound and that
>
statistical analyses are appropriate and rigorous?
>
* Will this training include conflict of interest, federal codes
>
requirements, guaranteeing privacy and safety of research
>
participants, especially as pertaining to vulnerable
populations?
>
* Are there plans for creation and innovation in developing the
>
application of these topics to clinical research?
>
* As applicable, will this resource be sufficient for intra- and
>
inter-institutional operations?
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Other additions:
Integrating the School of Nursing.
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