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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

BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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Page 1: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

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Agenda

• Structure of the national CTSA • NCATS • The BERD KFC • The local BERD • Opportunities for engagement

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Structure

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Structure

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NCATS Creation National Center for Advancing Translational Sciences (NCATS)

Established on December 23, 2011 Part of Consolidated Appropriations Act 2012 (HR 2055)

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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

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• 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

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CTSAs Support Spectrum of Translation

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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

Page 10: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

CTSA Consortium Website

www.ctsacentral.org

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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

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The BERD KFC

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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

Page 14: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

Communication

• Bimonthly operations groups calls

• Bimonthly KFC calls

• Monthly / bimonthly working group calls

• Annual face-to-face meetings

• Ad hoc meetings/calls as required

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Andrew Cucchiara University of Pennsylvania Online resources

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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

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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

Page 18: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

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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

Page 20: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 21: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

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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

Page 23: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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)

Page 24: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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.

Page 25: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 26: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

Evaluation - metrics Chul Ahn UT Dallas

• BERD Metrics – 2011 and 2012 Survey:

• 100% response rate • NCRR administrative supplement

Page 27: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

Evaluation Metrics Goals

• Measure contributions of BERD (within and across institutions)

• Facilitate strategic planning (institutions and nation-wide)

• Identify trends – annually

Page 28: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

How should we improve professional environment?

Create a Centralized Academic Home

StronglyAgree

Agree

Disagree

StronglyDisagree

Provide Institutuional Funds

StronglyAgree

Agree

Disagree

StronglyDisagree

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Integrate BERD Leadership

StronglyAgree

Agree

Disagree

StronglyDisagree

Implement Promotion & Tenure Guidelines

StronglyAgree

Agree

Disagree

StronglyDisagree

How should we improve professional environment?

Page 30: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

Dedicated Time for Professional Activities

StronglyAgree

Agree

Disagree

StronglyDisagree

How should we improve professional environment?

Page 31: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

BERD Activities

ConsultingEducation/mentoringBERD ResearchNon-BERD ResearchScientific ReviewCTSA Consortium

Page 32: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 33: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 34: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

BERD research

# of proposals submitted with BERD personnel as PI, Project, Program or Core Director

Not Tracking<55-1011-2021-30>30

Page 35: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

BERD Research

# of manuscripts published with BERD personnel as the first or corresponding author

Not Tracking01-1011-2020-30>30

Page 36: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

Non-BERD Research

# of proposals supported

Not Tracking<2020-5051-100>100

Page 37: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

Non-BERD Research

# of requests for funding of biostatisticians

Not Tracking<2020-5051-100>100

Page 38: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 39: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

Future Directions for Evaluation

• Analyze, analyze, analyze • Humanize with Success Stories • Support the growth and development

of our specialty

Page 40: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

Evaluation – Professional development

Leah Welty Northwestern

Page 41: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 42: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 43: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 44: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 45: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

Institutional Support

• Budget required to handle funding fluctuations, recruitment costs, training and transition time for new statisticians

• Fund education and unfunded collaborative projects

Page 46: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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?

Page 47: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 48: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 49: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 50: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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.

Page 51: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

BERD • 2011

– 6 Biostatisticians/Epidemiologists – 2 Ethicists – 1 Postdoc – 3-4 Masters-prepared staff – 2 experienced investigators – 2 CTRC nurse coordinators

Page 52: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

Consultation request

Triage

Intake

Support plan

Page 53: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 54: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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.)

Page 55: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 56: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

• 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.)

Page 57: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 58: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

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

Page 59: BERD and CTSA: Biostatistics, Epidemiology and Research ... seminar.pdf · BERD and CTSA: Biostatistics, Epidemiology and Research Design within the Clinical and Translational Science

Questions / Comments?