Ensuring Diversity and Inclusion in Clinical TrialsWednesday, 18 May 2022 - ET (Eastern Time, GMT-05:00)

Introduction & Self-Reflection exercise

Exploring disability inclusivity to diversify clinical studies

• The importance of including a diverse range of disabilities
• Physical, mental, invisible, transient– are they all being accounted for when recruiting for trials?
• Disability Selectivity without bias
• Increase focus on those disproportional affected from illness due to disabilities
• Where is the data on disability diversity in clinical studies
• How to increase participation of those with varying disabilities in clinical studies
• Exclusion of those in disability community

• What is LGBTQ+, why does inclusivity in trials matter
• The population identifying as LGBTQ+ is increasing but demographic in trial does not match this- why?
• Hardships members of LGBTQ face in healthcare, how this translates to lack of participation in clinical trials
• Steps to create a welcoming clinical trial (visible welcome, language, trainings)
• Steps to ensure protocols are inclusive (data collection, differentiation between sex and gender, sexual partner not assumed)
• Increasing our focus on transgender inclusivity: Men with cervixes, Women with prostates. Do we need to ask all questions to all genders or be selective with questions based on gender identity without being invasive?

• The population identifying as LGBTQ+ is increasing but demographic in trial does not match this- why?
• Hardships members of LGBTQ face in healthcare, how this translates to lack of participation in clinical trials
• Steps to create a welcoming clinical trial (visible welcome, language, trainings)
• Steps to ensure protocols are inclusive (data collection, differentiation between sex and gender, sexual partner not assumed)
• What is BMs doing to ensure inclusion from the LGBTQ+ community?

• Discussing topics from LGBQ+ and Disability sessions
• Why it is important to include these demographics in trials
• Hurdles encountered when increasing diversity in these groups
• Personal accounts from members identify with groups, or those trying to increase participation from these demographics

• Addressing the lack on inclusion of those from low socioeconomic background when this demographic is disproportionately affected by health issues
• Education level and low socioeconomic status – is there a lack of understanding surrounding clinical studies and their purposes
• Inclusion without financial exploitation
• Increasing support for those of lower socioeconomic backgrounds
• Methods to increase participation in trails of those from a lower socioeconomic background

• How non-inclusive language creates barriers to engagement
• The importance of plain language
• Health literacy and informed decision-making
• How can we ensure language is appropriate and inclusive?
• Culturally safe communication in clinical research
• Improving communication through co-creation with communities

• Overview of health equity & applying health equity to research
• Modifying practice and research to be more inclusive(APA)
• The psychology behind Community Based Participatory Research (CBPR) and how that can influence clinical trials
• Communication between patient & provider
• Five tips to achieving health equity (APA)
• CSC peer clinical trials support program

A Chance to grab a refreshment, interact with attendees and speakers!

• Introduction of me and my medical history/story
• My experience with clinical trials
• Examples and interactions with the FDA at a Patient-Focused Drug Development Meeting
• What do patients think about when considering a clinical trial?
• Barriers to patients in clinical trials
• Increasing access and diversity in clinical trials
• Considerations for rare disease patients in clinical trials
• Supporting and including the rare disease community in clinical trials
• The World of Rare Disease video on rare disease treatments (if time allows)

Hosted by Wendy Warring - NEHI

• Factors affecting participation: Socio-economic background, language, trust, and accessibility
• Starting points in addressing barriers
• Examples of successfully implemented programs that increased trust and participation from diverse groups in trials
• Issues encountered when addressing these barriers

Keynote Speaker

• How will decentralised trials bring about more diversity?
• Insight into current pilot on decentralised trials and obstacles encountered thus far
• Technologies adopted to digitalise clinical studies
• Hybrid model – using technology for check-ins and questionnaires
• Digital literacy and technology inequities and access - will digitalization create a new, unwanted bias?