DIVERSITY, EQUITY & INCLUSION I


n recent years, clinical research has undergone a transformative shift, embracing a more patient- and community-centric approach


throughout the entire life cycle of treatment and product development. While some of these practices have been present in pockets of health and clinical research—particularly in oncology and rare diseases—and are closely related to patient advocacy, they are now being implemented more holistically across the clinical trial space. This shift aims at a cohesive, end-to-end patient engagement strategy, starting from setting priorities and designing research programs during pre-clinical work through to post- approval activities. Despite an apparent downturn in the overall


research economy, it is evident that a commitment to the multifaceted discipline of patient-centricity is a definitive strategic direction taken by research professionals at all levels, industry organizations of all sizes, and across various patient populations and indications. This evolution reflects a broader recognition of the vital role that patients and communities play in shaping engagement and participation in research, improving research outcomes, and enhancing the overall efficacy and relevance of clinical trials. Critically, the tendency to reject or deprioritize patient- centric activities in the interest of efficiency is diminishing. Industry and cross-collaborative groups gather and validate data supporting improved study performance and a greater likelihood of achieving treatment and product goals when meaningful patient-centric activities are effectively planned and executed. In other words: what benefits patients also benefits researchers’ other metrics. This editorial explores interconnected areas of patient-centric initiatives from a broader perspective, highlighting examples that drive meaningful changes in clinical research.


Patient and community involvement and engagement One of the most significant foundational shifts towards patient-centricity in clinical research is greater patient and community involvement. Traditionally, clinical trials were designed with limited input from those most affected by the


conditions being studied. Today, it is increasingly recognised and expected—by regulators, patient communities, and advocates—that patients and community members be involved from early on and throughout the research process. Numerous real-world implementations and data from studies on patient-centric practices demonstrate that this approach leads to more relevant and impactful research outcomes, improves trial efficiency—including recruitment, retention, and reduced complexity—and fosters genuine collaboration. Patient advisory boards, community partnerships, and participatory research models are becoming standard practices, transforming from mere consultation to a strategic opportunity with reciprocal benefits.


Reduced participation burden and decentralised clinical trials Reducing the burden of participation has been a critical focus in modernising clinical research. Traditional clinical trials often require participants to visit research sites frequently, which can be inconvenient and prohibitive, especially for those with limited mobility or living in remote areas. This challenge has led to the development of decentralised clinical trials (DCTs), which leverage technology to bring research to participants’ doorsteps. The coronavirus pandemic accelerated the adoption of DCT models to maintain trial operations. Although there has been a return to traditional brick-and-mortar models, the increased logistical complexity remains, even in hybrid trials. However, improved standardisation and technology in DCTs can help reach underrepresented populations who might otherwise be excluded due to geographic or socioeconomic barriers.


Diversity, Equity, and Inclusion (DEI) The integration of diversity, equity, and inclusion (DEI) principles is crucial in a patient- and community-centric approach. Recent changes across the industry and regulatory expectations have improved understanding and action toward trial diversity, particularly concerning race and ethnicity. This shift is essential for generating research findings that are more broadly applicable


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