What Do We Mean by 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: This course focuses on the importance and dimensions of diversity, exploring the current landscape of diversity in clinical trials, and diversity in clinical trials of recently approved drugs.

Topics:

1. What is diversity?
2. Dimensions of Diversity: Race, Ethnicity, Sex, Gender, and Ancestry
3. Intrinsic vs. Extrinsic Factors
4. Target Patient Populations
   • Consideration of genetics, physiological differences, co-morbidities, geography, and multi-factors in studies for new products
5. Study Populations in Clinical Research
6. Challenges: Bringing New Drug to Market
   • Regulations
     • Good laboratory practices: 21 CFR 58
     • Good manufacturing practices:21 CFR 210-211
     • Good clinical practices: 21 CFR 11, 50, 54, 56, 312, 314, 320, 812, 814
   • Goal: Obtaining approved labeling
7. Examples: Where Differences Exist
   • ACE inhibitors, carbamazepine, isosorbide dinitrate/hydralazine, and rasburicase
   • Race and ethnic differences across drugs
8. Demographics in U.S.
   • Demographics in clinical trials participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA from 2010 to 2012
   • Necessity of clinical trial data to include underrepresented populations
9. Overview of the Complexity of the Issue
   • Dimensions of diversity: age and sex represent biological differences
   • Race and ethnicity represent social constructs
   • Interrelationship between dimensions of diversity
   • Trust in the clinical trial process
10. COVID-19: Exposes Differences in Vulnerability
    • Moderna, Inc. - efforts to recruit underrepresented groups

Speaker:

Eunjoo Pacifici, PharmD, PhD, is the Chair and Associate Professor of Regulatory and Quality Sciences and Associate Director of the International Center for Regulatory Science. Dr. Pacifici received a BS in Biochemistry from the University of California Los Angeles followed by a PharmD and PhD in Toxicology from the University of Southern California. She conducted her graduate research in the laboratory of Dr. Alex Sevanian in the Institute for Toxicology where she studied the mechanism of oxidative damage and repair in endothelial cell membrane. Before returning to USC as faculty, Dr. Pacifici worked at Amgen and gained experience in conducting clinical research with a special focus on the Asia Pacific and Latin America regions. She initially worked in the clinical development group managing U.S. investigational sites and central laboratories and then went on to work in the Asia Pacific / Latin America group interfacing with local clinical and regulatory staff in Japan, the People’s Republic of China, Taiwan, and Mexico. She represented regional clinical and regulatory views on therapeutic product development teams and led satellite task forces in order to align local efforts with U.S. activities. Her additional professional experiences include community pharmacy practice in various settings and clinical pharmacy practice at the Hospital of the Good Samaritan in Los Angeles. Her current focus is on developing the next generation of regulatory scientists and pharmacy professionals with the knowledge, tools, and skills to expedite the development of innovative, safe, and effective biomedical products. epacific@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 0.5 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 first 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