Enhancing diversity and inclusion in clinical trials and publications – A call to action

Broadening the demographic diversity of clinical trial patient populations, including by age, gender and ethnicity, will enable better translation of clinical trial findings to the real-world setting. There are many barriers to patient inclusion in clinical trials, such as: lack of trust; language and communication problems; lack of knowledge about clinical trials and their eligibility criteria; and inadequate access to clinical trial sites.

Following publication of FDA guidance on ensuring diversity in clinical trials and how they are reported, Synergy and its sister agencies within HCG’s Publications Centre of Excellence are committed to facilitating discussion on how medical communication professionals can shine a light on health inequity.

To promote discussion, HCG’s Publications Centre of Excellence took the opportunity to present a poster at ISMPP 2023 reporting on the impact and limitations of demographic underrepresentation on clinical trial results. Titled ‘Leveling the playing field: Diversity, equity, and inclusion (DEI) in clinical research and publications’, the poster highlights barriers to DE&I and presents an opportunity for medical communications professionals to proactively report the impact and limitations of inequitable representation on clinical trial findings, and encourages diversified authorship of publications. Listed below are several actions we can take immediately to support more diverse and equitable patient representation in clinical trial publications:

• Increase our own awareness and knowledge of the available FDA DE&I guidance and other regulatory requirements to improve understanding of how best to equitably collect results and conduct trials, and proactively question underrepresentation
• Share DE&I learnings cross-functionally both within and across healthcare agencies
• Leverage evolving technologies, such as AI for language translation and colour-blindness accessibility assessment tools

Please join us in the discussion and use this link to share your views on how we can all identify and optimise strategies to ensure diverse and equitable patient representation in clinical trials and data reporting.