Inclusivity of diverse populations in clinical research is the best way to ensure clinical equity for patients worldwide. The reality of this is especially evident now, as it has become an underlying imperative in clinical research that better reflects the real-world.
There is a lot of groundwork to be done, such as tapping into patient communities that need new products, building awareness of clinical research within underserved populations, and understanding the essence of the patient voice.
Additionally, free expression of gender has led to more acceptance of self and a growing group of people whose gender does not match their biology from birth. It is the responsibility of the pharmaceutical and biotechnology industry to adapt clinical trials to accommodate everyone.
We must ensure that investigational new drugs and clinical trials account for all communities in the effort to make medical treatments accessible and clinical trial data representative of the heterogenous populations in which approved drugs will actually be used.
But how? The US Food and Drug Administration (FDA)’s recent draft guidance document titled “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; a Draft Guidance for Industry; Availability” is a move in the right direction for diversity and inclusion. However, there is much to be desired and no mention of diverse gender inclusion or a more robust classification of ethnicity and races.
Join our panelists for an insightful discussion as they explore this new draft guidance, where it falls short, and what our industry still needs to address in order to make clinical trials more inclusive for all.
Aman Khera, Vice President, Global Head of Regulatory Strategy, Worldwide Clinical Trials
Aman Khera is Vice President and Global Head of Regulatory Strategy at Worldwide Clinical Trials and has been providing global strategic direction in regulatory affairs for more than two decades. She has built her career on maintaining fastidious patient care with the pragmatism needed to help clients achieve effective global regulatory strategies. She is committed to diversity and inclusion in clinical research and advises within industry, on how best to action into practical strategies, .
Aman is available to consult with companies of all sizes, as well as their funding entities, to support their goals, with the primary aim of serving humanity as a whole.
Jeff Trotter, Senior Vice President, Scientific Solutions Real World Evidence, Worldwide Clinical Trials
Jeff Trotter, Senior Vice President for Worldwide Evidence™, supports customers with the critical transition from clinical development to commercialization. With more than three decades of experience and an MBA from Northwestern University, Jeff brings a pioneering spirit to the evolving health economics and outcomes research community. As an accomplished speaker and author with over 50 published articles and research papers, he prioritizes personalized customer service, practical guidance based in experience and candid communications grounded in mutual respect and cultural sensitivity through his role at Worldwide.
Shawn Trutna, Patient Recruitment and Retention Strategist Lead, Clinical Operations Site Management, Worldwide Clinical Trials
Shawn Trutna is an Associate Director within the Patient Recruitment and Retention department at Worldwide Clinical Trials with over 15 years of experience working on strategies that ultimately increases clinical trial awareness to those interested in learning more about treatment options available to them. Shawn specializes in thinking outside the box and determining cost-effective strategies that contribute to the wellbeing of all involved when conducting a clinical research study. Shawn is a dynamic leader and uses his positive energy to collaborate with others to work hard and exceed identified study-specific recruitment and retention challenges.
Allison Kemner, Vice President of Clinical Sciences and Operations, Tyra Biosciences
Allison Kemner is the Vice President of Clinical Sciences and Operations at Tyra Biosciences. Her formative educational years were spent in Philadelphia, PA, where she developed a deep understanding of the intersection of social structures, healthcare and access barriers. Allison became an oncology nurse transitioning to clinical development after completing a rigorous dual-master’s program at the University of Pennsylvania. Her educational and professional experiences fueled her focus on clinical trial access. She is a passionate leader whose efforts target aggressive measures that both broaden inclusivity and augment diversity with the ultimate aim to improve patient outcomes.
Who Should Attend?
This webinar will appeal to VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:
- Clinical Affairs
- Clinical R&D
- Clinical Research
- Clinical Pharmacology
- Clinical Operations
- Project Management
- Regulatory Affairs
- Medical Affairs
- Patient Recruitment and Retention
What You Will Learn
Bring your questions and join us for an insightful event of panelists discussing:
- What the FDA’s draft guidance means for diverse and inclusive trials?
- What barriers exist for inclusion from different races and ethnicities, sex, gender and trans inclusion and how could we work around them?
- Is there a plug and play solution?
Worldwide Clinical Trials
Worldwide Clinical Trials is a global, midsize contract research organization (CRO) that provides top-performing bioanalytical and Phase I-IV clinical development services to the biotechnology and pharmaceutical industries.
Founded in 1986 by physicians committed to advancing medical science, our full-service clinical experience ranges from early phase and bioanalytical sciences through late phase studies, post approval, and real-world evidence. Major therapeutic areas of focus include cardiovascular, metabolic, neuroscience, oncology, and rare diseases. Operating in 60+ countries with offices in North and South America, Eastern and Western Europe, Russia, and Asia, Worldwide is powered by its more than 3,000 employee experts.
For more information, please visit www.worldwide.com or connect with us on Twitter, LinkedIn, Facebook, and Instagram.
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