To commemorate World Clinical Trials Day, we spoke with Christel Huguet, Executive Vice President and Head of Research and Development at Ipsen, to discuss the importance of diversity from all aspects of the R&D process in accelerating innovation. I explored sexuality.
Hello, Christel! Health inequalities pose one of the most pressing public health challenges of our time. How can increasing diversity and inclusion in research and development address these disparities?
To me, health equity means that everyone in the world has access to safe, effective, and innovative treatments, regardless of ethnicity, gender, age, disability, language, or other distinguishing characteristics. To do. To achieve this, new treatments must be tested in different demographics, as responses to drugs may differ due to genetic, physiological, and environmental reasons. At Ipsen, we make intentional choices, including the number and location of trial sites, to increase diversity in our clinical trials, especially those from minority or marginalized communities who experience many barriers to participation. continues to be underestimated. This means there is a real opportunity to improve health equity by improving diversity in clinical trials. But we must take a step back and recognize the importance of increasing diversity across the entire healthcare ecosystem, from community organizations, policy makers, and regulators to healthcare providers and researchers. not. We all have a role to play.
It seems like collaboration is very important for us to make progress. How does Ibsen promote diversity and inclusion, and how does this impact the research and development process?
Diverse teams bring different perspectives, beliefs, and experiences to help foster a culture of creativity, innovation, and responsibility. At Ibsen, we only source our pipeline through external innovation. This is a strategy that recognizes the value of integrating diverse expertise from across our research and development teams and affiliated biotechnology and academic centers.
In research, this increases the likelihood of making new scientific discoveries and allows us to design and execute robust, ethical and inclusive development processes. Diverse representation fosters a deeper understanding of barriers to clinical trial participation and ensures that protocols and recruitment processes are careful and inclusive.
We also regularly engage with patient organizations to inform them about our development programmes. Their extensive knowledge of patient communities means they can provide valuable insights and considerations that help remove barriers and promote equitable participation in research for all individuals.
After all, increasing diversity starts with fostering an inclusive environment where all individuals feel welcome and valued, and their unique contributions are encouraged. As an industry, we have made great strides in promoting diversity, but there is still work to be done. That's why we've set clear and actionable D&I goals as part of our Generation Ibsen commitment.
What other steps is Ibsen taking to contribute to this transformation, and what challenges does it face?
As we continue to expand our network of clinical trial sites into more countries, we are expanding beyond large centers with limited access to healthcare and clinical leads. Ipsen now has its first clinical trial site in China to study treatments for fibrodysplasia ossificans progressiva (FOP), helping to diversify the data we collect on this ultra-rare disease . However, because of Ibsen's focus on rare diseases and niche indications, we face unique challenges in increasing the diversity of our clinical trials. This setting, where the number of clinical trial participants is limited, introduces a broader range of gender, age, ethnicity, and comorbidities, so the quality and strength of the data collected is limited by dropouts and small numbers of participants. (e.g. population). Therefore, increased diversity must be carefully balanced with the ability to draw clear and statistically significant conclusions from the data. If we don't, we risk not meeting our primary endpoints and potentially never reaching patients with potentially life-changing drugs. Ibsen's team is considering these challenges in a variety of ways, including pushing the boundaries of biostatistics to process diverse data, identify small trends, and prevent bias. We are also looking more closely at what we measure and optimizing secondary exploratory endpoints to fully understand subpopulations. At the end of the day, if you start by building a diverse team and prioritizing inclusion, the rest will follow.
Finally, as we consider new FDA legal requirements aimed at increasing diversity in clinical trials, how will Ipsen ensure that we meet these standards going forward? It is not only a scientific necessity, but also an ethical imperative, and Ibsen is committed to playing our part in this effort. Over the next year, our research and development team will critically evaluate how we approach trial design, protocol development, participant recruitment, and data analysis, and develop a clear strategy to continue to drive greater diversity in trials. We will focus on the formulation of .
Christel Huguet
Managing Executive Officer, Head of Research and Development Headquarters
