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:

The importance of diversity, equity, and inclusion in clinical research will be emphasized as well as obstacles to enrolling patients from diverse populations and implications for not enrolling patients from diverse populations.

Topics:

1. Diversity, equity, and inclusion (DEI)
   • Sites, sponsors, patients, the diverse voice
   • Importance of DEI
2. Annual FDA issues the Drug Trials Snapshot Report
3. Why is DEI important?
   • Disease and illness do not discriminate
   • Age, race and ethnicity does determine effects of certain conditions and medical treatments
   • Research not representative of the treatment’s true intended patient population
   • Elements to diversity
4. Variation in disease manifestation and treatment responses
   • FDA reviewing approved labelling related to specific race and ethnicities
5. Obstacles in reaching diverse populations
   • Sponsor and site level
   • Investigator or clinical research staff perspective
   • Community and patient perspective
   • No harmonized requirements for data collection
   • Inherent lack of data standards
6. Engaging communities
   • Sponsor companies receptive to change
   • Reach out to research naïve sites
   • Offer translation or interpreter services
   • Assess patient burden
7. The diverse voice
   • Acknowledge and understand cultural competencies
   • Different dimensions of diversity
     • Age, gender, ethnicity, socioeconomic status, etc.
     • Intersectional ties

Speaker:

Aman Khera, is the Global Head of Regulatory Strategy at Worldwide Clinical Trials, a mid-size Clinical Research Organization (CRO). Aman joined Worldwide from a large global CRO, where during her 17-year tenure; she led and developed many functions and services within Regulatory, ranging from regulatory intelligence function to business development and streamlining the many initiatives to develop regulatory services, most recently holding the position of Head of Americas for the Regulatory Strategy and Agency Liaison team. She is an accomplished leader and expert in regulatory affairs with a 23-year record of accomplishments within the CRO environment in providing global strategic direction in regulatory affairs. She has led a wide variety of regulatory projects providing regulatory strategy and development services for a variety of client sponsor companies ranging from virtual companies to large companies in many therapeutic indications. Her career is built on helping clients achieve their initiation to end regulatory strategies from study submission to commercialization.She is an active volunteer in regulatory associations; served on the editorial panel of the peer-reviewed journal, the Regulatory Rapporteur as well as currently serving as Chair of the North American Chapter for The Organization for Professionals in Regulatory Affairs (TOPRA). Aman is also a member of the TOPRA Diversity Committee and has taken a special interest in diversity and inclusion within industry. aman.khera@worldwide.com

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 fourth course in a six (6)-course program. To complete the entire program and earn a badge CLICK HERE.