As the world is becoming more and more diverse there is a big need to consider a wide audience when conducting clinical trials. In this presentation, you'll get insights into why it's important to look at diversity, equity, and inclusion on a global level and which efforts are being made by Boehringer Ingelheim in this space through collaboration with diverse stakeholders.

Diversity in Clinical Trials (DICT) a global approach for one company to ensure access for all in their clinical research studies. Hear how our team has taken a practical approach in different countries to identify barriers, build new communication pathways, and to support access for patients through healthcare providers and their teams. Learn how different requirements and opportunities in countries ex USA have driven our approach to equity.

Inspired by its success in the United States, Moderna is forging ahead with its commitment to inclusive healthcare research in the UK and Europe. The company has made significant strides in patient recruitment and retention, ensuring that clinical trials are a mirror of those most impacted and likely to benefit from new therapies. By prioritizing the visibility and understanding of scientific research, Moderna's approach cultivates trust and engagement, paving the way for equitable access to future medical advancements.

Join this engaging Fireside Chat to delve into the latest insights on the FDA's requirements for Diversity Action Plans. We'll discuss the implications for sponsors and explore effective strategies to ensure diverse populations are recruited for clinical trials. Gain an understanding of the process for creating and submitting a plan to the FDA, while navigating the uncertainties surrounding FDA expectations and feedback. Engage in thoughtful discussions on involving individuals impacted by the disease in clinical trials, and examine the challenges and improvements in plan submissions.

This session will take you on a research road trip—not to different locations, but instead to different settings beyond the hospital clinic. Hear how new, flexible ways of working and adaptable research delivery models are breaking down boundaries, increasing accessibility, and creating opportunities to generate real-world evidence. From places of worship to prisons, supermarkets, care homes, schools, hospices, and festivals—direct delivery transforms research delivery by taking research to the people.

The FDA has led the charge with its recently updated draft guidance. As sponsors of global studies, ensuring that patients in our studies reflect those who may use the medicine requires capabilities that go beyond the U.S. FDA requirements. We will share our experience in building enterprise-level capabilities to improve diversity through design, planning, execution, and monitoring, in line with AstraZeneca's global diversity ambition.

This multi-speaker panel presentation aims to catalyze a paradigm shift in participant data return. Participants will discover insights into current initiatives driving change and explore available solutions for securing leadership endorsement, integrating participant data return into operational processes, defining the details of the data to be returned based on organizational parameters, and acknowledging and addressing the potential concerns or challenges with operationalizing the participant data return. The session intends to raise awareness, build trust, and influence a cultural and operational change around participant data return.

Learn about strategies that have been shown to improve the recruitment of socioeconomically disadvantaged populations into clinical trials. See recent data on current levels of implementation of such strategies among clinical trial sites. Discuss perceived challenges associated with the implementation of these strategies and how to better support sites in their ability to support prospective and current clinical trial participants.

A reliable enrollment forecast is key in clinical trials for resource optimisation and clinical supply planning. This proposal introduces a Bayesian methodology for optimising enrollment forecasting in clinical trials. By incorporating real-time data updates, such as one-month actual enrollment data and latest thinking from sites, the proposal ensures that forecasts remain dynamic and reflective of current trends, improving overall forecasting reliability and decision-making capabilities.

As new technologies emerge that prove useful tools for research in collecting various types of data in real-world settings, it is important to evaluate whether or not they bring with them the unintended consequence of leaving some populations behind. New wearables, sensors, and other digital health technologies can revolutionize our ability to contextualize data and capture real-time measurements of clinical trial study participants. However, if these technologies are only accessible to certain groups (e.g., high socio-economic status or non-rural communities or require high education attainment) their use and implementation may perpetuate poor representation in clinical research. In this panel, experts will discuss the importance of identifying and recognizing the use of technologies (either the devices themselves or the methods in which they are presented) that have the potential to serve as a bridge and improve clinical trial accessibility and participation by populations historically left out of biomedical research.