Improving Diversity in Research and Development to Drive Health Equity

To mark World Clinical Trials Day, we sat down with Christelle Huguet, Executive Vice President, Head of R&D at Ipsen to explore the importance of diversity from all sides of the research and development process, as we accelerate innovation.  

Hi Christelle! Health inequities pose one of the most pressing public health challenges of our time. How can improving diversity and inclusion within research and development help address these disparities?

To me health equity means that everyone around the world has access to innovative treatments that are both safe and effective, regardless of their ethnicity, gender, age, disability, language, or any other distinguishing characteristic. To achieve this, novel treatments must be validated in different demographics, since they may respond differently to medicines for genetic, physiological, and environmental reasons. At Ipsen we make purposeful choices to enhance clinical trial diversity, including the number and location of trial sites, however underrepresentation persists, particularly amongst minority or marginalized communities who experience many barriers to participation. This means that there is a real opportunity to help improve health equity by improving clinical trial diversity. But we must also take a step back and acknowledge the importance of greater diversity across the full spectrum of the healthcare ecosystem – from community organizations, policy makers and regulators to healthcare providers and researchers – we all have a part to play.

It sounds like collaboration is really important for us to make progress. How does Ipsen encourage diversity and inclusion and what impact does this have on the R&D process?

Diverse teams bring a variety of perspectives, beliefs and experiences to the table which helps fosters a culture of creativity, innovation and responsibility. At Ipsen we source our pipeline exclusively through external innovation, a strategy which recognizes the value of uniting varied expertise from across our R&D teams and the biotechs and academic centers with which we partner.

Within research, this can increase our chances of making new scientific discoveries and help us to design and execute robust, ethical and comprehensive development processes. Diverse representation facilitates a deeper understanding of the barriers preventing clinical trial participation, ensuring protocols and recruitment processes are sensitive and inclusive.

We also routinely engage with patient organizations to inform our development programs. Their extensive knowledge of patient communities means they are able to provide invaluable insights and considerations that can help us remove barriers and promote equitable participation in studies for all individuals.

Ultimately, increasing diversity starts with fostering an environment of inclusivity, where all individuals feel welcomed and respected, with their unique contributions encouraged. As an industry, we are making great strides to encourage diversity however, there is still work to be done which is why we have set out clear, actionable D&I targets as part our Generation Ipsen commitment.

What other steps is Ipsen taking to contribute to this transformation and what challenges do you face?

We are continually expanding our network of trial sites to more countries, but also to beyond the big centers, where access to healthcare and clinical leads is limited. Ipsen currently has the first ever trial site in China for investigating treatments for Fibrodysplasia Ossificans Progressiva (FOP) which is helping us to diversify the data we collect for this ultra rare disease. However, because at Ipsen our focus is on rare diseases and niche indications we face unique challenges to increasing clinical trial diversity. In this setting, where clinical trial participant numbers are limited, as we introduce a greater range of genders, ages, ethnicities and co-morbidities, the quality and strength of data collected could be impacted through drop-out or small numbers (e.g. sub-populations). We must therefore carefully balance increasing diversity with the ability to draw clear and statistically significant conclusions from the data, or otherwise risk not meeting primary endpoints and preventing a potentially life-changing medicine from reaching any patients at all. There are a number of ways our teams at Ipsen are exploring these challenges, including how we can push 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. Ultimately, if you start by building a diverse team and prioritising inclusivity, the rest should follow.

Finally, when considering the new FDA legal requirements aimed at improving clinical trial diversity, how will Ipsen ensure it meets these criteria moving forwards? Ensuring diversity in clinical trials is not only scientifically necessary, but also ethically imperative, and Ipsen is committed to playing our part in this journey. Over the coming year, a strong focus for our R&D team will be critically assessing how we approach trial design, protocol development, participant recruitment and data analysis to inform the development of a clear strategy on how we can continue to encourage greater diversity in our trials.

Christelle Huguet

Executive Vice President, Head of R&D