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BERD and CTSA: Biostatistics, Epidemiology and Research
Design within the Clinical and Translational Science Consortium
Christopher J Lindsell, PhD
Chair, BERD KFC Co-Director, CCTST BERD
Vice Chair for Research, UC Emergency Medicine 24 May 2012
Agenda
• Structure of the national CTSA • NCATS • The BERD KFC • The local BERD • Opportunities for engagement
Structure
Structure
NCATS Creation National Center for Advancing Translational Sciences (NCATS)
Established on December 23, 2011 Part of Consolidated Appropriations Act 2012 (HR 2055)
To catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions
Led by the National Center for Research Resources, the CTSA program supports a national consortium of medical research institutions that work together and share a common vision to:
www.ncats.nih.gov
NCATS Mission
• Clinical and Translational Science Activities – Clinical and Translational Science Awards
• Rare Diseases Research and Therapeutics – Therapeutics for Rare and Neglected
Diseases – Office of Rare Diseases Research
• Reengineering Translational Sciences – Molecular Libraries and Imaging Program – Bridging Interventional Development Gaps – Toxicology in the 21st Century
NCATS Programs and Initiatives
CTSAs Support Spectrum of Translation
Assembling a Consortium: Recent Milestones
• 2011 June – consortium coordinating center “C4” funded at Vanderbilt
• 2012 March – CCEC meeting held at Vanderbilt to review CTSA mission and vision within NCATS
• 2012 March – RFI issued requesting responses on priorities for CTSAs
• 2012 ??? – New RFA
CTSA Consortium Website
www.ctsacentral.org
Challenges to the CTSAs Moving Forward
• Establish a consortial infrastructure that makes completion of multisite clinical studies faster, better, and cheaper
• Take national leadership in implementation of a new era in the protection of human subjects, to improve oversight and minimize burden/delays
• Facilitate an enriched pipeline of novel therapeutics and diagnostics moving from the laboratory into clinical testing
• Provide national leadership in development of clinical research informatics standards
• Develop better methods to engage patients and communities in the research process
The BERD KFC
Organization
Operations group
Reproducible research
Online resources
Ethics in statistical practice
CTSA C4
Data management and quality
Evaluation
Online journal club CTSpedia Education Professional
development Survey
Communication
• Bimonthly operations groups calls
• Bimonthly KFC calls
• Monthly / bimonthly working group calls
• Annual face-to-face meetings
• Ad hoc meetings/calls as required
Andrew Cucchiara University of Pennsylvania Online resources
Maintaining Educational Material/Updates: UCSF, Rochester, Vanderbilt, UCDavis, Mayo, Chicago, Rockefeller...
Encouraging Contributions of Materials from our Colleagues in Federal Agencies and from Industry
Reviewing the ASA’s Teaching of Statistics in the Health Sciences for Complementary Resources
Liaising with Education & Career Development KFC to Collaborate on Overlapping Activities
Maintain CTSACentral webpage
Education Bob Oster UAB
Provide a BERD Forum for Selection, Presentation and Discussion of Thought Provoking or Controversial Issues from the Biostatistical Literature
Maintain a Repository of Recorded/Transcribed Sessions to Allow Asynchronous Review and Forum Exchanges
Curate Exchanges to Produce a High Quality Document to Summarize the Review for BERD Members et al.
The first Online Journal Club May 24, 2012 “Principles for the Ethical Analysis of Clinical and Translational
Research” by Jonathan Gelfond et al.
Online journal club Peter Bacchetti Frank Harrell UCSF Vanderbilt
Provide a Forum for Ethical Guidelines in the Practice of Biostatistics in the Clinical & Translational Sciences
Compile a Bibliography of Biostatistical Ethics Articles
Maintain a Calendar of Previous and Upcoming Events Addressing the Ethical Practice of Biostatistics
Create a Repository of Recordings, Proceedings and/or Slides from Past/Future Presentations at Ethics Events
Webinars to address Ethical Controversies
Produce educational materials based on case studies of ethical issues, including suggestions of solutions
Ethical practice of biostatistics
Shelley Hurwitz Harvard
Creating Materials for Teaching Research Methods to Medical Residents which include REDCap use
Collaborating with FDA and Industry Statisticians on Best Practice for Treatment Trial Safety Graphics
Compiling Statistical Tools & Graphical Templates to Promote Best Practices for Analysis and Display
Producing video tutorials for R Studio, GitHub et al. Expanding Content to Include Comparative Effectiveness
Research Encouraging Ports of Contributed Statistical Code and Graphics
to Popular Programming Languages
CTSpedia Mary Banach, Laurel Beckett UC Davis
Reproducible research • Pushing RR as being critical to sound research • Identifying RR as a focus for biostatistics, epidemiology,and other quantitative methodologic disciplines
• Equipping methodologists with technical RR solutions • Recognizing the experimental method, sound design, and analysis as key to RR
• Motivating routine use of pre-specied statistical analysis plans
• Building content on CTSpedia.org • Compiling horror stories
Frank Harrell Vanderbilt
Data Management and Quality
Brad Pollock UT San Antonio
Rationale: • Data management operations are often a
pivotal component of biostatistics units conducting clinical and translational research
• Heterogeneous approaches are used • Opportunities to learn from each other as well
as from experts in informatics, clinical research management and other disciplines to improve the quality and efficiency of our BERD units
Data Management and Quality
Brad Pollock UT San Antonio
Goals • Improve processes related to the organization,
collection and retrieval of data used for hypothesis-driven clinical translational research
• Identify best practices and new methodological approaches to improve both the quality and efficiency of data operations managed by BERD units
Data Management and Quality
Brad Pollock UT San Antonio
• Highly multidisciplinary • Bridge for interactions with other KFCs
– Informatics KFC – Clinical Research Management KFC – Comparative Effectiveness Research KFC
• Bridge to other organizations – Standards groups (CDISC, cPath, caBIG) – Professional organizations (SoCRA, SCT,
ASA, AMIA)
Data Management and Quality
Brad Pollock UT San Antonio
• Data management and data quality are extremely important aspects of BERD units. – Strategic Goal 1: Build National Clinical and
Translational Research Capability • Increases national clinical and translational capacity through
the development of high quality databases and data-related processes.
– Strategic Goal 3: Enhancing Consortium-Wide Collaborations
• Improves the ability to conduct collaborative, inter-institutional clinical and translational research through the development of standardized database structures, platforms, and data management procedures.
Evaluation
Goal 1: Define national standards for BERD evaluation
Goal 2: Implement standardized assessment of
impact of consortium BERD units Goal 3: Facilitate dissemination of BERD
performance and “Success Stories”
Rickey Carter Mayo Clinic
Evaluation - metrics Chul Ahn UT Dallas
• BERD Metrics – 2011 and 2012 Survey:
• 100% response rate • NCRR administrative supplement
Evaluation Metrics Goals
• Measure contributions of BERD (within and across institutions)
• Facilitate strategic planning (institutions and nation-wide)
• Identify trends – annually
How should we improve professional environment?
Create a Centralized Academic Home
StronglyAgree
Agree
Disagree
StronglyDisagree
Provide Institutuional Funds
StronglyAgree
Agree
Disagree
StronglyDisagree
Integrate BERD Leadership
StronglyAgree
Agree
Disagree
StronglyDisagree
Implement Promotion & Tenure Guidelines
StronglyAgree
Agree
Disagree
StronglyDisagree
How should we improve professional environment?
Dedicated Time for Professional Activities
StronglyAgree
Agree
Disagree
StronglyDisagree
How should we improve professional environment?
BERD Activities
ConsultingEducation/mentoringBERD ResearchNon-BERD ResearchScientific ReviewCTSA Consortium
How many projects supported annually with consulting
0%5%
10%15%20%25%30%35%40%45%50%
Nottracking
0 1-100 101-200 201-300 >300
Educational activities
0%10%20%30%40%50%60%70%80%90%
100%
AcademicCredit Courses
Lectures,Workshops or
Seminars
Onlinecourses
Ccontinuingeducation
courses
Workshopson software
None of theabove
BERD research
# of proposals submitted with BERD personnel as PI, Project, Program or Core Director
Not Tracking<55-1011-2021-30>30
BERD Research
# of manuscripts published with BERD personnel as the first or corresponding author
Not Tracking01-1011-2020-30>30
Non-BERD Research
# of proposals supported
Not Tracking<2020-5051-100>100
Non-BERD Research
# of requests for funding of biostatisticians
Not Tracking<2020-5051-100>100
Scientific Review, Oversight, and Professional Services
0%10%20%30%40%50%60%70%80%90%
100%
NIH StudySections
Non_NIHExternal
StudySections
EditorialBoard forJournals
InternalStudy
Sections
ExternalAdviosry
Committee
PRMC/SAC
Future Directions for Evaluation
• Analyze, analyze, analyze • Humanize with Success Stories • Support the growth and development
of our specialty
Evaluation – Professional development
Leah Welty Northwestern
Biostatistics Units in AHCs
• Need for Biostatisticians in Academic Health Centers (AHC) is expanding
• However, many biostatistics units in AHCs are fragmented
• Biostatistics is considered ancillary, not an academic discipline
• We need to raise awareness for management of biostatistics in AHCs
Strategies for Developing/Managing Biostatistics Resources in AHC
1. Recruitment and retention 2. Centralization of Biostatistics Resources 3. Institutional Support 4. Using Biostatistics resources efficiently 5. Improving science through biostatistics
consultations
Recruitment and Retention
• Optimal for a senior biostatistician to direct recruitment of biostatisticians. – Can evaluate skills and knowledge – Have professional networks to identify candidates
• Create attractive environment – Need an academic home that values growth and
methodologic contributions – Path for promotion for statisticians – Collaborate with other statisticians – Strong leader and mentors
Centralization of Biostatistics Resources
• Better environment for the statistician • Statisticians can assist and educate each
other • Allows investigators to subscribe to a
portion FTE • Critical mass of statisticians to handle
fluctuations
Institutional Support
• Budget required to handle funding fluctuations, recruitment costs, training and transition time for new statisticians
• Fund education and unfunded collaborative projects
Building Efficiency
• Specialization in statistical and clinical areas
• Availability of students and staff to handle data management, programming and analysis
• Hardware and software support • 10% Rule: Never less than 10% on
project?
Improving Biostatistics Contributions
• Continuing education (conferences, seminars) and professional activities (grants, manuscripts, journal reviews, presentations) requires protected time
• Collaboration vs. consultation • Literacy and education of investigators
CTSA Recommendation
• Centralize biostatistics resources in a unit with strong leadership rather than fragmented units dispersed across clinical departments
• Advantageous to biostatisticians as well as investigators
• Start a dialogue with senior leadership about organization of biostatistics
What role can the CTSA have?
– Provide mentorship and career development support
– Provide the cohesion for diverse quantitative disciplines (CER, bioinformatics, statistics) and non-centralized environment
– Help to balance consultation/collaboration – Provide a framework for supporting
institutional service
CCTST BERD Aim 1: Create a unified core for providing research
methods, study design, analysis and clinical research ethics support to clinical and translational researchers across the AHC.
Aim 2: Integrate research methods, epidemiology, biostatistics, and ethics in clinical and translational research with other CTSA core services.
Aim 3: Generate innovative methodological research in biostatistics, research methods, and clinical research ethics that advances the science of clinical and translational research.
BERD • 2011
– 6 Biostatisticians/Epidemiologists – 2 Ethicists – 1 Postdoc – 3-4 Masters-prepared staff – 2 experienced investigators – 2 CTRC nurse coordinators
Consultation request
Triage
Intake
Support plan
Consulting capacity
• Increased focus on use of Master’s and post-doctoral level support
• Careful tracking of effort through documentation and bi-weekly report cards
• Distribution of new intakes as required to balance workload
• Maintaining at about 1,800 hours of direct support to investigators each year
Jan-Sep 2011 – 275 new projects
• 164 projects assigned for BERD • 111 projects direct-to-service
– 1,600 hrs provided by BERD • 768 Faculty hours • 832 MS/Post-doctoral hours
– Peak activity in spring and fall – Lowest activity in winter
Consulting capacity (cont.)
CCTST BERD initiatives
• Research record • Education modules on Bayesian trial
design, funded with a supplement award • Intersession with Hughes STEM high
school • Standardized intramural grant reviews • Created methods-specific grant
mechanisms
• Seminars/Webinars now coordinated jointly
• Methods-based CCTST Grand Rounds series, including GIS, ‘omics’, epigenetics, Bayesian adaptive trial design, ethics in online research, propensity scores, reproducible research, heterogeneity of treatment effects
CCTST BERD initiatives (cont.)
Ongoing Strategies
• Generate a “who’s who” and use it to engage methodologists from every corner of the AHC
• Implement/further develop ARPT criteria and career development pathway across the AHC
• Continue expanding continuous professional development activities across campus
• Implement mentorship program for methodologists
Getting engaged
• Join a BERD working group (Start a BERD working group!)
• Develop an innovative BERD program
• Attend workshops and seminars
• Join the “who’s who”
• Submit a proposal for a methods grant
• Help plan the resubmission
Questions / Comments?