FDA Initiatives to Address Diversity in Clinical Trials

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:

An in-depth discussion of FDA initiatives and guidance documents addressing diversity in clinical trials will be examined, including the FDA Safety and Innovation Act, FDA Action Plan, Drug Trial Snapshots, Clinical Trials Transformation Initiative, and the establishment of the Office of Minority Health and Health Equity, and the Office of Women’s Health.

Topics:

1. FDA Guidance on Diversity
2. Office of Women’s Health (OWH)
   • Scientific and education projects:
     • Research and Development
     • Outreach and Communications
     • Medical initiatives and Scientific Engagement
     • Project Hope: Women in Clinical Trials
3. FDA Safety & Innovation Act (FDASIA)
4. FDA Action Plan
5. FDA Guidance
   • Collection of Race and Ethnicity Data in Clinical Trials
   • Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs
   • COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
6. Labeling and Literacy – Drug Trials Snapshots
7. FDA Office of Minority Health and Health Equity (OMHHE)
8. Clinical Trials Transformation Initiative (CTTI)
   • CTTI Diversity Project
9. Case Studies
   • TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth Study)
   • Patient Navigator Program
   • Lupus treatment post-marketing research
10. NIH Initiative: Public Health Service Act
11. Diversity in COVID-19 Trials

Speaker:

Nancy Smerkanich, DRSc, MS, is an Assistant Professor, Department of Regulatory and Quality Sciences in the School of Pharmacy at the University of Southern California (USC).Dr. Smerkanich received her faculty appointment after successfully completing her Doctoral Dissertation on “Benefits Risk Frameworks –Implementation in Industry” in 2015.  In addition to teaching in courses related to drug development and clinical trials, she continues to provide regulatory guidance to industry peers. Nancy brings many years of practical regulatory knowledge and experience to academia where she participated in all regulatory aspects of product development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas. Known for her dedication to education and mentoring across industry, Nancy continues to be recognized for her ability to provide accurate, relevant and dynamic instruction on both the technical and strategic aspects of global regulatory affairs and for her service to professional organizations such as the Drug Information Association (DIA) and The Organization for Professionals in Regulatory Affairs (TOPRA).With over 30 years of experience, Dr. Smerkanich has participated in all regulatory aspects of drug development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas. Prior to joining Octagon, Dr. Smerkanich held various Regulatory Affairs positions within industry, including nine years at Merck and seven years as an independent consultant. Dr. Smerkanich holds a Doctorate and Master’s degree in Regulatory Science from USC and Bachelor of Science Degree in Microbiology and a Bachelor of Arts in Russian from the University of Connecticut. piresmer@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 1.0 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