Event Calendar

Opening Plenary

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2019 Agenda

Friday, September 27, 8:30 to 9:15

Welcome and Introduction

Ms. Harper and Ms. Jenkins will describe issues related to the practice of clinical research in the current regulatory environment and how SOCRA works to promote education and training within the clinical research community.  001 

Presenter: Jamie Harper, MHA, CCRP, Director of Clinical Research, Illinois CancerCare PC
Presenter: Amy Jo Jenkins, MS, CCRA, CCRC, CCRP,  Executive Director, Translational Research Institute University of Arkansas for Medical Sciences (UAMS)

Friday, September 27, 9:15 to 10:00

OHRP’s Thinking on Key Revisions to the Common Rule

Compliance to the revised Common Rule became effective on January 21, 2019. Dr. Lau will provide updates on OHRP’s thinking on key revisions.002

Presenter: Yvonne Lau, MBBS, PhD, Director, Division of Education and Development, U.S. Department of Health and Human Services, Office of Human Research Protections 

Friday, September 27, 10:30 to 11:15

Creating and Sustaining Diverse Study Enrollment: Towards a Quantifiable Science of Recruitment

Many, if not most, clinical trials struggle to complete study enrollment on time and within budget. Similarly, diversity in clinical trial enrollment remains elusive for most study teams, in spite of determined, thoughtful, and concerted efforts. Common barriers to recruitment as well as recent efforts to concretize a scientific study of applied research recruitment will be discussed. Dr. Jackson will illustrate how recruitment science operationalizes efforts to develop, compare, and generalize best practices in study accrual, drawing on principles of engagement with underserved communities to improve recruitment and retention for all populations in clinical research. 003

Presenter: Jonathan Jackson, PhD, Director, CARE Research Center, Massachusetts General Hospital & Harvard Medical School

Friday, September 27, 11:15 to 12:00

FDA’s Bioresearch Monitoring Program - Foreign Inspections and Program Updates 

Ms. Wright will provide an overview of international inspections conducted in support of FDA’s Bioresearch Monitoring Program and discuss the implementation of a dedicated inspectional cadre. Recommendations for supporting protocol compliance through Good Documentation Practices will also be reviewed. 004

Presenter: Barbara Wright, BGS, Supervisory Investigator, Foreign Inspection Cadre, Office of Bioresearch Monitoring, U.S. Food and Drug Administration

Pragmatic clinical trials, including comparative effectiveness research, are becoming increasingly prevalent. These trials aim to answer important research questions for multiple stakeholders and may be less expensive than conventional clinical research. In addition, these “real-world studies”, which are typically embedded in health care settings, often pose minimal incremental risks and burdens to participants. This suggests that the full range of protections employed for conventional research subjects may not be appropriate. However, designing and conducting pragmatic research has been associated with a surprisingly vexing array of ethical and regulatory challenges. Dr. Sugarman will describe the nature of pragmatic clinical trials, some of these challenges, and ways to address them.