Population on the Fringe of Clinical Trial Enrollment

The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Description:

Current efforts to address a lack of representation in clinical trials include Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA’s Action Plan, and the FDA Drug Trial Snapshot.Diversity metrics and statistics collected from these combined efforts will be highlighted as well as, research projects conducted by the USC Undergraduate Research Associates Program.

Topics:

1. Clinical trials
   • Purpose
   • Efficacy, Tolerability, and Safety
2. Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA)
3. FDA’s Action Plan: Priorities, Quality, Participation, & Transparency
4. FDA – Drug Trial Snapshot 2019
5. Diversity metrics for research in the U.S.
   • United States Census Bureau
   • Office of Management of Budget (OMB)
     • Minimal set of categories to represent race and ethnicity
     • Federal Register Notice
       • Racial, age, gender composition
   • Los Angeles County demographics
6. Example: Zolpidem
7. USC Undergraduate Research Associates Program
   • Inclusion of pediatric participation in clinical trials
   • Low-income populations and barriers to diabetes technology
   • Chronic disease in Los Angeles County
   • Race and ethnicity in mental health disorder clinical trials
   • Antidepressants among special and vulnerable populations

Speaker:

Terry Church, DRSc, MA, MS, is an Assistant Professor in Regulatory and Quality Sciences at the University of Southern California, School of Pharmacy. He is Associate Director of Undergraduate Education, and teaches in the undergraduate degree program, Pharmacology and Drug Development (PDD).  Dr. Church's academic focus is on interdisciplinary applications of pharmaceutical regulation in relation to patterns of addiction, disaster management, and education and training. His areas of interest and expertise include biorepository regulation and ethics; drug addiction and regulation of controlled substances; regulatory practices for continuity and disaster planning; and policies and ethics of academic research. Dr. Church is an avid supporter of creative arts therapies and was involved in the initial set up of the Institute for Arts in Medicine at USC. Terry is a faculty fellow of the USC Center for Excellence in Teaching and co-chair of the educational committee of the Institute for Addiction Sciences.Dr. Church holds a Doctor of Science and Master of Science in Regulatory Science from the University of Southern California, a Master of Arts in Cultural Anthropology from Temple University, and a Bachelor of Arts in Social Sciences from the University of Pittsburgh. tdchurch@usc.edu

Learner Level: Beginner/Intermediate/Advanced

Audience: This symposium is designed for Clinical Research Assistant/Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with 1- 2 years of clinical research experience. Individuals may be new to clinical research with limited knowledge of clinical trial conduct, good clinical practices, regulations and common terminology associated with clinical research.

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. Attendees to this CNE activity will be awarded 0.75 Continuing Nursing Education contact hours from ENPDC.

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the second course in a six (6)-course program. To complete the entire program and earn a badge CLICK HERE.

Learner Disclosures:

Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.

Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.

Awarding Contact Hours: To obtain contact hours participants must:

·       Review the entire activity

·       Pass the quiz 

·       Complete the evaluation at the end

 Certificates will be distributed at the end of the evaluation.

Enduring Materials Dates:

·       Start Date: 4/22/2024

·       Expiration Date: 4/22/2027