This comprehensive document outlines a principled, multi-stakeholder approach to optimizing the inclusion of diverse populations in clinical research and includes practical resources and tools that can be adapted for any given protocol. The authors adopt a broad definition of diversity, including demographic factors (e.g., sex, race, age, genetics), as well as non-demographic factors (e.g., comorbidities, organ dysfunction, concurrent medications, environmental factors, compliance)....
More DescriptionThis comprehensive document outlines a principled, multi-stakeholder approach to optimizing the inclusion of diverse populations in clinical research and includes practical resources and tools that can be adapted for any given protocol. The authors adopt a broad definition of diversity, including demographic factors (e.g., sex, race, age, genetics), as well as non-demographic factors (e.g., comorbidities, organ dysfunction, concurrent medications, environmental factors, compliance). Beginning with scientific, ethical, and social arguments for diverse inclusion, as well as its business value, the document identifies a number of barriers to inclusion, and importantly, addresses potential approaches and solutions to improve diverse representation in clinical research. Chapters explore broadening engagement, data standards and analysis, study design and conduct, and the accountability of each stakeholder. Specific recommendations and case examples are provided. The guidance is accompanied by a Toolkit to facilitate change.