In today’s conversation, we explore the crucial issue of diversity in clinical trials with Bethany Hills Grois, a noted legal expert. Echoing her latest publication, “Fostering Inclusivity in Clinical Trials: A Vital Step Towards True Innovation for All,” we delve into the challenges and opportunities for enhancing diversity in clinical research. Bethany illuminates the concerns, highlights the role of AI tools, and provides a practical perspective on ensuring the inclusion of diverse populations in clinical trials, aligning with her commitment to equitable and comprehensive healthcare outcomes. Join us in this insightful dialogue as we navigate this essential aspect of clinical research with Bethany.

Moe Alsumidaie: Bethany, your publication brings to light significant concerns about diversity complicating the analysis in clinical trials. Could you delve deeper into these concerns and explain why diversity hasn’t naturally occurred in the clinical trial setting?

Bethany Hills Grois: The main concern is the introduction of many cofounders and comorbidities with the inclusion of diverse groups in clinical trials. This situation is feared to complicate the analysis, affecting the development of P values and, ultimately, the approval process. Some of it is about access and the significant impact on numbers and statistics fundamental to the innovation and approval processes in clinical trials.

Moe: Given these concerns, how can we overcome these fears and ensure the inclusion of diverse populations in clinical trials?

Bethany: It’s about understanding and addressing this fear. We need to explore whether the statistical models preferred by the FDA do not support the type of necessary diversity in our studies or if it’s due to the narrow inclusion/exclusion criteria for our label and patent process. Tackling these issues is vital for ensuring the inclusion of diverse populations in clinical trials, enhancing their healthcare access, and the overall relevance and applicability of clinical trial results.

Bethany Hills Grois
Bethany Hills Grois

Moe: You have mentioned the potential role of AI tools in addressing these issues. Could you shed more light on this?

Bethany: Absolutely. AI tools hold significant promise in addressing these challenges. They can aid in patient targeting and analyze the connection between a drug and its mechanism of action in diverse patients. We can utilize AI tools to ensure that diverse populations are exposed to the right drug amounts more efficiently, allowing their inclusion in clinical trials. This approach helps to filter out noise and ensure that the results are due to the drug’s effects, enhancing the reliability and generalizability of the trial results.

Moe: How do you see the industry’s readiness to embrace these AI tools to ensure diversity in clinical trials?

Bethany: The industry needs to lean into leveraging AI tools. Until that happens, we might face challenges in ensuring diversity in clinical trials, essential for bringing important therapies to diverse patient populations.

Moe: Considering the growing role of AI tools in enhancing diversity in clinical trials, as you have mentioned, how do you envision the regulatory landscape adapting to these technological advancements?

Bethany: It’s a vital aspect to consider. As the industry leans more into leveraging AI tools to enhance clinical trial diversity, regulatory bodies will likely need to adapt and evolve. The focus will be on ensuring that the use of AI tools adheres to the standards of safety, efficacy, and ethical considerations. It will be essential for regulatory guidelines to be updated to reflect these technological advancements, ensuring that AI tools are utilized effectively and ethically in clinical trials while maintaining the trials’ rigor and integrity. The collaboration between regulatory bodies and industry stakeholders will play a significant role in shaping this evolving landscape, ensuring that the regulations enhance diversity in clinical trials while upholding the highest research and patient care standards.

Moe: What are the prospects and challenges in ensuring diversity in clinical trials and the role of AI tools in this context?

Bethany: I foresee a more inclusive and diverse clinical trial landscape propelled by the strategic use of AI tools. The future holds the promise of AI ensuring efficient and comprehensive inclusion of diverse populations in clinical trials, leading to more robust and universally applicable trial results. However, challenges will persist. The industry’s adaptation to and acceptance of AI tools, the evolving regulatory framework, and the continuous need to balance innovation with ethical considerations and patient safety will be critical areas to navigate. Ongoing collaboration, transparency, and a commitment to diversity and inclusion will be essential in overcoming these challenges and realizing the full potential of clinical trials in the future.

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Moe Alsumidaie Chief Editor
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.