Broadening Participation in Clinical Research

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 highlights the importance of ensuring clinical studies reflect a wide range of patient groups and experiences. It explores challenges in enrolling patients and examines the implications for limited participation on research outcomes.

Topics:

1. Importance of Recruiting Across All Groups in Clinical Research
   • Sites, sponsors, patient perspectives
2. Annual FDA issues the Drug Trials Snapshot Report
3. Why broad participation matters in research
   • How treatment responses vary across different groups
   • Research not representative of the treatment’s true intended patient population
   • Key factors influencing participant differences
4. Variation in disease manifestation and treatment responses
   • FDA reviewing approved labelling related to specific patient groups
5. Obstacles in reaching a wider patient pool
   • 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. Key demographic factors in clinical research
   
   • Ties that bind groups together

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).

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.

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