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Training Workshop to Ensure Diversity, Inclusion and Meaningful Participation in Clinical Trials, the ABC Cardiovascular Disease Study (A CME Program)

Sponsored by FDA Conference Grant: 1R13FD005981-01

March 10 -11, 2017, Atlanta Georgia







Friday, March 10, 2017


6:00 pm – 6:45 pm                 Reception and Meet & Greet


6:45 pm – 7:00 pm                 Welcome and Introductions

                                                Sandra Harris-Hooker, PhD

                                                Executive Vice Dean, Morehouse School of Medicine


7:00 pm – 7:45 pm                 Update on Peripheral Artery Disease

                                                Elizabeth Ofili, MD, MPH, Senior Associate Dean, Morehouse

School of Medicine and Principal Investigator, RCMI

Translational Research Network ( RCMI CC )


7:45 pm – 8:00 pm                 Questions and Discussion


8:00 pm – 8:15 pm                 Closing Remarks



Saturday, March 11, 2017


7:30 am – 8:30 am                 Breakfast and Registration


8:30 am – 8:45 am                 Welcome and Introductions


                                                Elizabeth Ofili, MD, MPH, Senior Associate Dean Morehouse                                                             School of Medicine and Principal Investigator, RCMI                                                               Translational Research Network ( RCMI CC )


                                                Barbara Hutchinson, MD, President, Association of Black                                                       Cardiologists (ABC), President, Chesapeake Cardiac Care

                                                Felix Sogade, MD, Chairman of the Board, Association of Black                                              Cardiologists (ABC) CEO Georgia Arrhythmia Consultants &                                                       Research Institute


                                                Cassandra McCullough, Chief Executive Officer, Association of                                                           Black Cardiologists (ABC)


Emma Fernandez, PhD, Chair of the RCMI CC Steering Committee


8:45 am – 9:00 am                 US Department of Health and Human Services Action Plan to Reduce Health Disparities and the Role of Minority Serving Institutions

                                                Jonca C. Bull, MD: FDA Assistant Commissioner for Minority Health


9:00 am – 9:10 am                 Discussion, Question & Answer Period


9:10 am – 9:25 am                 The ABC Cardiovascular Study to Improve the Care of Underserved Minority Patients

                                                Elizabeth Ofili, MD, MPH, Principal Investigator and Chair of the Steering Committee



9:25 am – 9:35 am                 Discussion, Question & Answer Period


9: 35 am – 9:50 am                The Duke Clinical Research Institute Collaboration and

                                                Duke CARRA Registry

                                               Laura E. Schanberg, MD, Professor of Pediatrics, Co-Chief,

Pediatric Rheumatology


9:50 am – 10:05 am                 The ABC Cardiovascular Study: Global Outreach and

Collaboration with the Nigerian Cardiac Society and Sickle Cell Foundation of Nigeria

Janet Ajuluchukwu, MBBS, FNCP, Professor and Head Department of Medicine, University of Lagos, Nigeria



10: 05 am – 10:20 am                        Discussion, Question & Answer Period


10: 20 am – 10:30 am            BREAK


10:30 am – 10:45 am             The NIH Precision Medicine Initiative (All of Us)- Patient Registries and Biological Samples

Priscilla Pemu, MD, MS, Director, Community Physicians Network (CPN)

Alanna Morris MD, MSc, Assistant Professor of Medicine

Emory University Clinical Cardiovascular Research Institute Lilly Immergluck, MD, MS, Director, Pediatrics CPN


10:45 am – 11:00 am             Discussion, Question & Answer Period



11:00 am – 11:15 am             Ethical Considerations in Research Participation and Informed Consent

Stephen Sodeke, MS, PhD, Bioethicist and Professor; Chair, Institutional Review Board; Tuskegee University National Center for Bioethics in Research and Health Care & College of Veterinary Medicine, Nursing and Allied Health Sciences



11:15 am – 11:25 am             Discussion, Question & Answer Period



11:25 am – 11:40 am             Bringing the Patient’s Voice into Clinical Trial Design, Implementation and Dissemination

The Use of Mobile Technologies for Patient and Community Engagement

Priscilla Pemu, MD, MS, Director of Clinical Trials and Community Physicians Network


11:40 am – 11:50 am                         Discussion, Question & Answer Period


11:50 am – 12:20 pm             LUNCH



12:20 pm – 1:05 pm               Community Engagement in Clinical Trials: The Role of Community Advisory Board and Research Navigators

Rev. Dr. Jason E. Owens, D Min., Chair Community Advisory Board, Senior Pastor of Snellville Biblical Deliverance Center in Snellville, GA

Rev. Dr. Leland Jones, Sr. D Min., Greater New Light Missionary Baptist Church, Atlanta

Brian Rivers, PhD, Director U 54 Cancer Research Program


1:05 pm – 1:20 pm                 Discussion, Question & Answer Period



1:20 pm – 1:45 pm                 Engaging Community Physicians and Federally Qualified Clinics in Clinical Research

  1. Steen James, MD, Co-Chair Community Physicians Network
  2. Waine Kong, PhD, Executive Director, Zoe Pediatrics

Michelle Brown, CEO, Morehouse Choice Accountable Care Organization (ACO)

Deneta Sells, MD, In town Pediatric & Adolescent Medicine

Priscilla Johnson, MSN, PhD, Contracting and Business Associate Agreements


1:45 pm – 2:00 pm                 Discussion, Question & Answer Period


2:00 pm – 2:10 pm                 BREAK


2:10 pm – 2:25 pm                 The Business of Clinical Trials: Staffing Model for Conducting Successful Clinical Research Studies in Private Practice

Barbara Hutchison MD

President Association of Black Cardiologists

Felix Sogade, MD

Chairman of the Board, Association of Black Cardiologists


2:25 pm – 2:40 pm                 Discussion, Question & Answer Period



2:10 pm – 5:00 pm                 Spotlight Session: RCMI CC Innovation Catalyst

Description: A Proof of Concept Center @ RCMI

Translational Research Network ( RCMI CC )

Supporting Biomedical Innovation

  • Pilot funding for first in man studies conducted by RCMI CC /RCTRs
  • IRB guidance to obtain clinical samples/access databases
  • Technical Guidance on filing Provisional Patents
  • Technical Assistance on SBIR grant process
  • Consultation on Start Up Company
  • Regulatory guidance on IND/IDE
  • Online seminars
  • “Seed” Start Up funding “membership” RCMI U54


                         Session Leaders:

Emma Fernandez, PhD, Principal Investigator, RCMI at University of Puerto Rico Medical Sciences Campus

James Lillard, PhD, Associate Dean for Research and Director, Office of Technology Transfer, Morehouse School of Medicine

Solomon Garner, PhD RCMI CC Data Coordinating Center




             Tom Saylor, Entrepreneur-in-Residence

             Advanced Technology Development Center (ATDC)                  Enterprise Innovation Institute at Georgia Institute of             Technology


2:40 pm – 3:00 pm                 Breakout Sessions

3:00 pm – 3:20 pm                 Breakout Sessions

3:20 pm – 4:40 pm                 Breakout Sessions

4:40 pm – 5:00 pm                 Breakout Sessions


5:00 pm – 5:30 pm                    Debrief and Closing Remarks

                                                Main Conference Room



Breakout Session Topics and Workshop Leaders


Multi Site Principal Investigators and Co-Investigators: ABC Cardiovascular Study Good Clinical Practice Session


Description: Good clinical practice (GCP) is an international, ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinksi, and that the clinical trial data are credible (FDA).


During this breakout session, a team of experienced clinicians will discuss good clinical practice standards and how these standards should be applied to conducting safe and ethical clinical studies that produce valid and reliable outcomes data. Vanguard Study PIs and coordinators must attend this session



Session Leaders

Barbara Hutchison, MD, Annapolis, Maryland

Felix Sogade, MD, Macon, Georgia

Priscilla Pemu, MD, MSCR

Lilly Immergluck, MD, MSCR

Anne Dennos, MSPH, CCRC

Clinical Trials Coordinator, CARRA Registry/DCRI Project Leader

Duke Clinical Research Institute


Session participants (ABC Cardiovascular Study Vanguard Sites):

Barbara Hutchison, MD, Annapolis, Maryland

Felix Sogade, MD, Macon, Georgia

Joe Hargrove, MD, Little Rock, Arkansas

Philip Duncan, MD, Richmond, Virginia

Osita Onyekwere, MD, Anniston, Alabama

Andre Artis, MD, Indianapolis, Indiana

Marcus Williams, MD, Newark, New Jersey

Malcolm Taylor, MD, Jackson, Mississippi

Adefisayo Oduwole, MD, Atlanta, Georgia


Investigator and Coordinator Training on ABC Cardiovascular Study Electronic Case Report forms (Medidata RAVE)


Description: This session will review the electronic case report form including data security and privacy, and clinical research data management.


Session Leaders:

Anne Dennos, MSPH, CCRC

Clinical Trials Coordinator, CARRA Registry/DCRI Project Leader

Duke Clinical Research Institute

Said Talbi, PhD Director, Information Security and Technology Integration (ISTI) and Interim Director, RCMI CC Data Coordinating Center

Alnida Ngare, Director, Clinical Data Services, RCMI CC data Coordinating Center


Recruitment and Retention

RCMI Coordinating Center ( RCMI CC ) Learning and Action Communities for Research (LACH), to support Community Engagement & Participant Registry


Description: This interactive breakout session will discuss best practices and methods for recruiting and retaining minority participants in clinical studies. Session leaders will discuss outcomes and lessons learned from the recently funded RCMI CC LACH project that utilized the RCMI CC and Morehouse School of Medicine community engagement platforms to successfully recruit more than 60 participants. Using a mixed methods approach, the study explored minority perspectives regarding participating in clinical studies.


Session Leaders:

Latrice Rollins, PhD, Evaluation Leader, RCMI CC

Nicole Crowell, MS, Project Director, RCMI CC

Pam Cooper, R-CENTER Recruitment Manager R-CENTER

Debra Teague, CPN Program Manager R-CENTER



RCMI CC Profiles and eagle-I Demonstration for Clinicians and Research Clusters


Description: The RCMI CC Profiles is the network’s collaboration tool for querying expertise and establishing professional connections for team science. Currently, the Profiles system is searchable with more than 1,800 professional profiles representing the diverse spectrum of scientific expertise and skills that exist at the RCMI-funded universities, colleges, and medical schools. Eagle-I facilitates access to research resources

This session will show participants how to navigate RCMI CC Profiles database networking tool for collaborative opportunities and help research professionals connect across institutions. Eagle-I will foster collaborations by providing information on how to access RCMI network research resources


Demonstration Facilitators:

Rene Baker, MPH, Research Implementation Manager, RCMI CC

Traci Hayes, Director Of Communications, RCMI CC

Cassandra Jackson, Administrative Program Manager, RCMI CC

Solomon Garner, PhD, Director, Research Resources and Research Networking, RCMI CC


Co-sponsored by the RCMI Coordinating Center ( RCMI CC ) funded by the National Institute on Minority Health and Health Disparities, National Institutes of Health (NIH), through Grant: U54MD008149.

The conference is also supported by the RCMI Clinical and Translational Research Center from the National Institute on Minority Health and Health Disparities (NIMHD) Grant: 8 U54 MD007588, and the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR000454.

The content of the workshop is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.