Atlanta Clinical & Translational Science Institute - PowerPoint Presentation

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Atlanta Clinical & Translational Science InstituteThrough focused education and training, innovative support of discovery, and ethical community engagement, the collaborative partners of ACTSI rapidly and efficiently translate scientific discoveries to impact all populations of the Atlanta community and beyond.February 16, 2016 – ACTSI Presentation to Andres Garcia, PhD

4/8/2016

ACTSI Leadership Retreat – November 19, 2015

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The CTSA Program is designed to develop innovative solutions that will improve the efficiency, quality and impact of the process for turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public.

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Purpose of CTSAsSupport high quality translational and clinical research locally, regionally, and nationallyFoster innovation in research methodsFoster innovation in training and career development

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ACTSI Academic Partners

ACTSI Healthcare Consortium

Georgia Collaborators

National Collaborators

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Executive and Leadership Councils4/8/2016

David S. Stephens, MD (PI) Emory

Elizabeth O. Ofili, MD, MPH (Senior Co-PI) MSM

Jeff M. Sands, MD (Co-PI) Emory

Greg S. Martin, MD, MSc (Co-PI and CRN Program Director) Emory

Ravi V. Bellamkonda, PhD (Co-PI) Georgia Tech

Sandra Harris-Hooker, PhD (Advisor) MSM

Herman A. Taylor, Jr., MD, MPH, FACC, FAHA (Advisor) MSM

R. Paul Johnson, MD (Advisor) Emory

Linda McCauley, RN, PhD, FAAN, FAAOHN (Advisor) Emory

Henry M. Blumberg, MD (Research Education, Training and Career Development Program Director) Emory

John J.

Hanfelt

, PhD (Biostatistics, Epidemiology & Research Design Program Director) Emory

Andrew Post, MD, PhD (Biomedical Informatics Program Director) Emory

Tabia

Henry

Akintobi

, PhD, MPH (Community Engagement Research Program Director) MSM

Carlton D. Dampier (Ethics & Regulatory Program Director) Emory & Children’s

Cynthia Wetmore, MD, PhD, (Pediatrics Program Director) Emory and Children’s

Carolyn C. Meltzer, MD (Research Technologies Program Director) Emory

Eric J. Nehl PhD, MS (Tracking and Evaluation Program Director) Emory

Executive Council

Leadership Council (includes all Executive Council members)

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Administrative Home4/8/2016Debora A. ClemAdministrative DirectorClinical

Research Network / Emory University

Andrew C. West, MBA, MHACenter Administrator, Sr.Emory University Sidnee Nicole Paschal Young

Director

of Finance

Emory

University

Elizabeth Pittman Thompson

Director

of Communications

Emory

University

Rondereo

Sidney

Program

Manager

Morehouse

School of Medicine

Martha J. Willis, MS

Program ManagerGeorgia Institute of Technology Cheryl SrokaProject

CoordinatorResearch Education, Training, & Career Development (RETCD) / Emory University Bekeela M. Watson, MPHManager, Program & ResearchBIP, BERD, Pilot Grants, & Research Technologies / Emory University

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Weekly eRoundup4/8/2016

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Three Sections, lots of acronyms…CommunityDiscoveryTrainingBERDBIPCRNCERPLIMSTL1KL2RETCD4/8/2016

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Community4/8/2016

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Community Engagement & Research Program (CERP)Sustained cross-institutional MSCR CE course w/RETCD - New format fall 2014 - 24 StudentsPublication of ARRA Supplement Results (

Health Promotion Practice and

Journal of Healthcare for the Poor and Underserved)Research Discovery Mini-Grants and Dissemination Grants (2 pilot; I dissemination)

Four-part Grant Writing Series (From Community Engagement-Evaluation)

e-Healthy

Strides

- Funded as

Transdisciplinary

Collaborative Center

for

Health Equity (NIH-NIMHD) subproject for adaptation across Morehouse Healthcare ACO

HERCULES

- Community Engagement Core of the

Emory Environmental

Science

Center

Second

Annual Community Partnership

Forum / June 2015 - 169

participants

CERP Steering Board advising ACTSI website revamp

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4/8/2016

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Research Match

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Discovery4/8/2016

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Biomedical Informatics Resources4/8/2016

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eBIRT

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Biostatistics, Epidemiology and Research DesignThe following biostatistical services are available:Rapid response to your statistical question Review of proposalsSample size and statistical power calculationsStudy design consultationReview of questionnaire/data collection form design statistical analysisPre-submission critique of statistical methods in journal manuscriptsGuidance on statistical genetics, genomics, neuroimaging and high-throughput data analysis

4/8/2016

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Clinical Research Network (CRN)Research nursing for participant visits, phlebotomy, IV access, medication administrationRecruitment core supportInpatient space for participant visitsResearch pharmacy supportBionutrition supportClinical Data Extraction Service CenterSafety oversightAtlanta Hospital Hospitality House

Web-based participant scheduling & protocol trackingLab support for processing, aliquoting, and storage

Outpatient space for participant visitsProgram director expertiseSleep/apnea studiesExercise physiology supportAncillary lab support

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Tier 1: Hospital Based Clinical Research SitesEmory University HospitalMSM Clinical Research Center*Grady Memorial Hospital*Emory University Hospital MidtownChildren’s Healthcare of Atlanta*

Atlanta VA Medical Center

South Fulton Medical CenterEmory-Georgia Tech Center for Health Discovery & Well BeingWinship

Cancer Institute Phase 1 Unit

Saint Joseph’s Hospital, Research Institute

Emory Emergency Department Research Program

Tier 2: Medical Office Based Clinical Research Sites

Mason Outpatient Transplant Unit

Emory-Children’s Cystic Fibrosis Center of Excellence

Brain Health Initiative

Emory Ophthalmology Research Program

Grady Ponce Center

Morehouse Medical Associates

Community Physician’s Network

Hope Clinic

Grady Diabetes Clinic

Emory Autism Center

Georgia Tech Research Institute

Tier 3: Community Based Clinical Research Sites

Southside Community Health Center

Grady East Point Neighborhood Clinic

West End Medical Center

Oakhurst Community Health Center

Emory Genetics Metabolic Nutrition Program & LSD, Fragile X, Downs Syndrome Research Program

VA Community Based Outpatient Centers

*

also pediatric sites

Pediatric Clinical Research Sites

Children’s at Scottish Rite (future)

Children’s at Egleston

Emory-Children’s CenterChildren’s at Hughes Spalding

Associated Laboratory Sites

Emory Clinical & Translational

Research Laboratory

Emory Integrated Genomics Core

Clinical

Research Network

including

Pediatrics

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Studio Meeting – Coordinated, Expert Assistance with Translational Research Proposals, Protocol Design & SupportThe intent of a Studio is to: provide

expert advice at

the beginning and most effective time in the proposal creation process or protocol design stage

provide

a

one-stop venue

for investigators in order to standardize support and

produce successful grant submissions

h

ave an investigator understand and be aware of all available

resources

(using

eBIRT

) and

expertise available within the ACTSI

Based on past investigator feedback, Studios provide value by:

“

learning about

resources”

“

review of protocol for internal validity” “

discussing and brainstorming grant ideas”

“IT and data management”

“sample size determination”

“data management

assistance”“reassessment of long term needs”

“helped us to plan how to get to the point where we are able to integrate basic and clinical studies”“meeting other researchers interested in technology”

Due

to increasing complexity and advancement in

clinical and translational research, investigators often need multi-disciplinary expert advice and assistance as they develop research proposals and

design protocols.

To receive

this assistance, investigators can schedule a Studio meeting through the ACTSI

. T

he

Studio meeting provides access to ACTSI experts in

biomedical informatics, biostatistics

and/or

regulatory, ethical

and

protocol design support

.

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Ethics & RegulatoryRegulatory AgreementsIRB Reciprocity Agreements between all ACTSI partners Inter-institutional Data Use Agreements & IP MOUs

Ethical Dilemmas in Scientific Research & Professional Integrity

Reviewed 400+ research ethics scenarios provided by students & research teams

Creation of website (2009) with >50 cases with complete formal analysis

4

th

most visited page with over 4,500 visits annually

Recent

ACTSI/

Winship

Collaborative Ethics Consultation Service completed 7 consults

&

presented

to 6 depts.

Ethical dilemma video on Authorship completed

In Progress

Emory to sign onto the Accelerated Clinical Trial Agreement

Developing/filming other ethical

dilemma videos &

podcasts

National CTSA

Clinical Research Ethics Consultation Collaborative member with 3 consults completed

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CR-Assist: 535 studies since deployment, 121 active studies, 55,708 participants, and 947 usersNautilus LIMS data: used

by 195 studies and 456 users

RedCap:Total active projects: 357

Projects created in FY 2016: 49

Total active users: 3,242

Total user accounts: 3,288

Invested

in an i2b2 data warehouse system which houses and feeds electronic heath records of Emory Healthcare and Morehouse Healthcare.

i2b2

helps link patients to researchers who intend to conduct clinical

trials.

BIP director

Andrew Post is co-author of a paper about

Eureka!*

that

was accepted by the

American Medical Informatics Association's Clinical Research Informatics

Summit

Biomedical Informatics Program (BIP) Highlights

* Eureka! was built by ACTSI’s BIP as a tool

for creating data registries for research from clinical data warehouses and supports clinical phenotyping.

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Over 900 instances of BERD support provided since 2007An ACTSI Studio session has led to an active collaboration between Dr. Jonathan Glass (Director, Emory ALS Center) and Emory biostatisticians on statistical methods for causal inference in observational studies, including ongoing dissertation research and a recent NIH R01 grant application by students and faculty in the Emory Department of Biostatistics and Bioinformatics.BERD director Dr. John Hanfelt

developed

an optimal 3-stage group sequential design for a clinical trial of immunosuppression therapy in post-transplant kidney recipients with Dr. Idelberto Badell (Assistant Professor of Surgery). 

This

design simultaneously achieves high power of identifying a successful therapy and minimizes the expected number of participants exposed to an unsafe therapy based on the biopsy-proven acute rejection rate.

Stemming

from a BERD review of a CRN protocol, BERD biostatisticians collaborated with ACTSI investigators Drs. Vin

Tangpricha

and Mansi

Kanhere

to design a pilot study examining the role of vitamin D repletion on gut and lung microbiota in cystic fibrosis patients.

Biostatistics Epidemiology & Research Design (BERD) Highlights

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Training4/8/2016

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Certificate Program in Translational ResearchA multidisciplinary program for PhD students, postdocs, and faculty who seek to conduct research at the interface between basic science and clinical medicine.This innovative and rigorous program gives PhD students, postdocs, and faculty the expertise and experience to translate fundamental biomedical scientific discoveries into treatments that will benefit human health.For more information, please visit the CPTR website: www.gs.emory.edu/translational4/8/2016

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Emory Master of Science in Clinical Research Laney Graduate School at Emory University, provides didactic and mentored clinical and translational research training Designed for Emory and Georgia Tech participants who hold a doctorate or equivalent degree and have demonstrated a commitment to a career in clinical investigationDeadline: April 1, 2016 5:00 PM (EST)

4/8/2016

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TL1: Medical Scientist TrainingMD/MSCR and PhD/MSCR dual degree programs to support predoctoral clinical and translational research training for medical students and other health professionals pursuing doctoral degrees in public health, biomedical sciences and nursing.Stipends and tuition support are available under the program to candidates not already being supported by other NIH T32 or F32 programs.Travel expenses will be covered by the TL1 program for travel to the Annual National TL1 Meeting.Applicants must be a U.S. citizen or permanent resident.TL1 Application Deadline: February 15, 2016 5:00 PM (EST).

4/8/2016

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KL2-Mentored Clinical and Translational Research Scholars ProgramCareer development for junior faculty at Emory, Morehouse School of Medicine and Georgia TechSalary support for at least 75% effort (50% is allowed for trainees from surgery or surgical subspecialties) on clinical and/or translational research and research

training$25,000 technical budget for research-related expenses and tuition for the Master of Science in Clinical Research (MSCR) degree curriculum

KL2 Application Deadline: March 1, 2016 5:00 PM (EST) 4/8/2016

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Pilot Grants Return on Investment69

external grant applications funded

$60.6M in external funds awarded~ 6:1 return in investment

63

rounds completed

240

projects funded

$10,410,904

disbursed

($5K

- $150K per project)

Other

Indicators of Success

3 patents issued

11 patents filed

12 invention disclosures

115

supported publications

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www.actsi.orgAtlanta Clinical & Translational Science InstituteRobert W. Woodruff Health Sciences CenterEmory University1440 Clifton Rd NE #134Atlanta

, GA 30322Andrew C. West, MBA, MHA

actsi@emory.edu(404) 727-9296

4/8/2016

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4/8/2016