Overview:
Many patients groups are underrepresented in clinical research, which impacts the ability to study the effectiveness of a treatment on people of different ages, races, and ethnicities. Regulatory agencies are advising on more robust planning to improve clinical trial diversity and advancing health equity as outlined in the Food & Drug Omnibus Reform Act (FDORA) 29 Dec 2022 and referenced in the recent FDA guidance on decentralised clinical trials on 2 May.
This webinar will present and discuss strategies to proactively assess and implement diversity in clinical trial planning, partnering with sponsors and research sites to ensure the best outcomes. Experts from patient recruitment, site networks, and in-home services discuss how a patient centric approach will increase diversity while minimising burden, for patients and study teams alike.
Participants will learn the following during the presentation:
Outlining diversity goals:
- Defining target populations
- Conducting situational analysis
- Thinking beyond race & ethnicity
Identifying patient centric enrolment barriers and operational challenges:
- Evaluating the protocol
- Conducting SWOT analysis through patient insights
Developing solutions that promote cultural sensitivity and minimise burden
- Identifying the right sites in the right locations
- Building trust through educational tools, targeted campaigns, and community outreach
- Proactively addressing patient burden via support, in-home services, and travel programs
Including recommendations in study plans and ensuring compliance
- Setting expectations around operational delivery
- Training, monitoring and outlining triggers for contingency activation
- Case Studies: examples of how to drive diversity in a phase 3 rare disease study, after study start and site selection
Speakers:
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Ashmee Bharadia
Ashmee Bharadia started her career in progressive roles from CRA to project management across Sanofi Aventis, Schering Plough, Novartis and Amgen covering respiratory, immunology, infectious, dermatology and neurology.
In 2016, Ashmee held a leadership position with a small CRO focused on developing the project management group and gained experience working with innovative start up and biotech companies. Ashmee also established a new group focused on strategic business optimisation, technology implementation, and global process improvements working with the corporate and operational leadership.
Ashmee holds qualifications in Lean Six Sigma and Change Management, and a BSc (Hons) in Pharmaceutical Chemistry from Queen Mary, University of London.
Susan Campbell
Tinaya Gray
Tinaya Gray has 25+ years of clinical research experience, primarily at CROs within operations delivery, with the last 17 at ICON. During this tenure Tinaya primarily lead portfolios in hematology and oncology and later as an executive director responsible for project delivery within the biotech unit.
Tinaya has community health equity experience that spans 3 decades of community work mostly focused on anti-poverty, racial, and justice reform. In her current role as Global Head of Diversity in Clinical Trials, Tinaya is the architect and leader of ICON's end-to-end Diversity in Clinical Trials Solutions, accountable for the development of ICON's strategic and operational capability for seamless delivery of inclusive trials and achievement of representative population data.
Target Audience:
Professionals in the following areas in the pharmaceutical, biotech or medical device spaces:
- Clinical Development
- Project Management
- Clinical Operations
- Procurement
- Outsourcing
- Strategy and Innovation
- Protocol Development
- Patient-Centric Innovation
- Business Operations
- Data Management
- Scientists and Biostatisticians
- Decentralised Clinical Trial Operations
- Clinical Science
- Outcomes Research
- Clinical Trial Planning and Optimization
- Medical Affairs
- Patient-Centric Innovation
- Site Managers / Site Networks