How to strategically plan and implement tactics to drive diversity in clinical research
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 US Food & Drug Administration (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 webinar —
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 program
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
Register for this webinar to discover patient-centric approaches that will increase diversity while minimising burden, for patients and study teams alike.
Ashmee Bharadia, Vice President, Accellacare In-Home Services
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 disease, 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 startup 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, Senior Director, Patient Recruitment Services, ICON
Bio coming soon.
Tinaya Gray, Executive Director, Project Delivery, ICON
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.
Who Should Attend?
Professionals in the following areas and roles in the pharmaceutical, biotech and medical device spaces:
- Clinical Development
- Project Management
- Clinical Operations
- Strategy and Innovation
- Protocol Development
- Patient-Centric Innovation
- Business Operations
- Data Management
- Decentralised Clinical Trial Operations
- Clinical Science
- Outcomes Research
- Clinical Trial Planning and Optimization
- Medical Affairs
- Patient-Centric Innovation
- Site Managers/Site Networks
- Scientists and Biostatisticians
What You Will Learn
Attendees will discover how to:
- Outline diversity goals by defining target populations and conducting situational analyses
- Identify patient-centric enrolment barriers and operational challenges
- Build trust through educational tools, targeted campaigns and community outreach
- Address patient burden via support, in-home services and travel programs
- Monitor and outline triggers for contingency activation in clinical studies
ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing a comprehensive suite of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. Our outsourcing models can be adapted to suit small local trials to large global programs, including full service, standalone services, FSP and full asset development.
With headquarters in Dublin, Ireland, ICON employs approximately 41,150 employees in 113 locations in 53 countries.