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

Speakers

Ashmee Bharadia, Accellacare In Home Services, part of ICON plc

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.

Message Presenter

Susan Campbell, Senior Director, Patient Recruitment Services, ICON

Susan Campbell is the Global Head of Patient Recruitment at ICON, where she is a senior leader in Patient Recruitment Services team. Susan has 25+ years’ experience in the clinical research industry with the majority of her time focused on patient recruitment & retention strategy development and operationalising global campaigns. She is passionate about bringing clinical research to patients as a care option and believes study participants are truly research heroes. In addition, Susan is focused on driving innovation and equity in clinical studies.

Message Presenter

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.

Message Presenter

Who Should Attend?

Professionals in the following areas and roles in the pharmaceutical, biotech and medical device spaces:

Clinical Development
Project Management
Clinical Operations
Procurement/Outsourcing
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

Xtalks Partner

ICON

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.