Abstract
In 2024, Denmark led the European Union in clinical trials per capita. This is celebrated as a marker of innovation, signalling Denmark’s research capacity and attractiveness to the global industry. Yet, trial volume alone provides a limited account of clinical research value and hides a more troubling reality: research is concentrated in commercially lucrative areas such as oncology and Alzheimer’s, while children, pregnant individuals, older adults, those with chronic pain, multimorbidity, or less profitable conditions are often overlooked. This mismatch is not merely a policy oversight. It reflects structural and epistemic injustices that determine whose bodies, experiences, and health outcomes are considered research-worthy. Drawing on Denmark as a national case example situated within broader European and international debates, this commentary highlights how inclusion strategies risk focusing on numeric representation rather than justice in knowledge production while also pointing to promising opportunities for inclusive innovation within the clinical research ecosystem in Europe. By moving beyond mere checklist inclusion, there is potential to foster a more equitable, reflective, and justice-oriented approach to participation and knowledge generation, one that benefits patients, researchers, and the broader society.
Keywords: Clinical studies, Inclusivity, Equity, Underserved and underrepresented populations, Epistemic injustice, Public–private partnership, Innovative health
Introduction: from trial volume to epistemic value
Denmark led the European Union (EU) in clinical trials per capita in 2024, a fact widely celebrated as evidence of a highly functional, innovative, and attractive clinical research ecosystem. From both policy and industry perspectives, high trial density signals efficiency, regulatory maturity, and international competitiveness. However, clinical trial volume alone offers a limited account of clinical research value. This commentary argues that contemporary inclusion strategies in clinical research risk reinforcing structural and epistemic injustices unless they are reoriented beyond numeric representation toward justice in knowledge production.
Our central claim is that current inclusion paradigms, while well-intentioned, often address who is counted in clinical trials rather than whose knowledge shapes them. As a result, underrepresented and underserved populations in Europe may be nominally included without meaningfully influencing health research agendas, study design, or interpretation of evidence. Drawing on Denmark as a national case example, and situating this within a wider European and international context, we examine how disease prioritization, demographic inclusion practices, and market incentives shape epistemic inclusion in clinical research.
We conclude by outlining how justice-oriented, reflective approaches, exemplified by unique initiatives such as the IHI READI project, may help realign clinical research with public health needs and social equity in Europe and beyond.
Denmark’s clinical trial landscape: leadership with blind spots
Denmark currently leads the EU in clinical trials per capita [1], with 33 studies per million inhabitants in 2024, well ahead of Belgium (24), Sweden (12), and Germany (6). These figures provide a compelling quantitative indicator of Denmark’s research capacity and clinical trial infrastructure. From the perspective of the pharmaceutical industry and policymakers, this position signals Denmark’s effectiveness in attracting and delivering high-quality clinical trials. As a national case, Denmark thus illustrates both the strengths and the limits of volume-based indicators of research success.
Yet, distribution is uneven. Trials cluster in certain disease areas, leaving less commercially attractive but medically significant conditions, such as pain management, antibiotic-resistant infections, psychiatry, and pediatric or geriatric care, largely untouched. More concerningly, patient groups such as children, pregnant individuals, older adults, and those with complex multimorbidities remain underrepresented in clinical trial portfolios, reflecting a bias that prioritizes economic feasibility over equitable access to innovation. Clinical studies underscore this disparity [2, 3].
This pattern is not uniquely Danish but reflects broader structural incentives across European clinical research. As such, while Denmark’s overall trial density is laudable, it risks reinforcing systemic disparities, where research efficacy coexists with selective inclusion. The result is a clinical research ecosystem that, in reality, benefits some patient populations while leaving others overlooked by the very ecosystem designed to help them.
Sex, gender,1 and representation: counting without knowing
A 2025 report jointly issued by the Danish Health Authority and Medicines Agency finds that while trial enrolment often mirrors disease-population gender ratios, gaps remain [4]. Women are underrepresented in cardiovascular and certain cancer studies despite distinct risk profiles and treatment responses. Men are underrepresented in conditions coded as “female,” such as migraines, eating disorders, and obesity. Here, clarity in terminology is essential. “Sex” refers to biological characteristics, while “gender” encompasses social roles, identities, and lived experience; “gender diversity” acknowledges identities beyond binary classifications.
These imbalances are clinically significant. Biological sex differences — including hormonal profiles, muscle mass, fat distribution, and pharmacogenetics — can affect drug metabolism and efficacy. When trials neglect these differences, interventions are optimized for the dominant group studied and extrapolated to others without robust evidence. Despite policy-level efforts in Europe to encourage inclusivity in clinical research, such as EU Regulation No. 536/2014 encouraging age and gender inclusion [5], implementation remains patchy and reactive.
The Danish case thus reflects a broader pattern within European clinical research: representation is often assessed through aggregate metrics that obscure lived realities of exclusion. Gender, while frequently counted, is rarely meaningfully analyzed. Clinical trials remain predominantly shaped around male default bodies and disease models, with women and gender-diverse populations incorporated later, if at all. Inclusion of underrepresented sexes and genders cannot be reduced to a box-ticking exercise; it requires genuine attention to the full spectrum of sex and gender as a critical epistemic commitment to improving evidence, treatment, and care across populations.
Inclusion as optics: when representation becomes performance
Global health systems have promoted inclusivity in clinical research since the 1970s, spurred by civil rights and feminist movements. In the USA, the NIH Revitalization Act of 1993 mandated inclusion of women and minorities in federally funded trials [6]. European approaches have followed with piecemeal policies, often tied to specific projects rather than systemic reform [7]. Many of these initiatives reflect genuine good-faith efforts by investigators and regulators operating under real ethical, logistical, and financial constraints. Nevertheless, their impact is often limited by an inclusion model focused on administrative compliance rather than structural change. In this section, we argue that contemporary inclusion practices often prioritize visibility and compliance over meaningful epistemic and structural transformation.
Demographic categories — such as “sex,” “gender,” “age,” and “ethnicity” — are treated as administrative checkboxes rather than analytical commitments. The result is a model of “data diversification” rather than one of genuine structural transformation [8]. Drawing on Star and Griesemer’s concept of boundary objects [9], terms like “underrepresented populations” or “vulnerable groups” function as shared but ambiguous categories that allow policymakers, researchers, and regulators to coordinate without consensus on meaning. While operationally useful, these categories also obscure complexity and flatten difference.
The concept of boundary objects illustrates how inclusion language can enable scientific coordination and numerical progress while simultaneously deferring difficult questions about responsibility, power, and design. For example, the label “underserved” may simultaneously apply to underrepresented ethnic groups, pregnant women, or people with disabilities, without specifying the mechanisms that render these groups underserved or the adaptations required to address that. In practice, inclusion becomes symbolic: groups are named and counted but rarely engaged on their own terms.
Moreover, such inclusion frameworks often rely on fixed demographic categories that are not only conceptually limiting but exclusionary. Participants are expected to fit within standard classifications, such as “female,” “Latinx,” or “transgender,” which may not reflect their lived experiences or intersectional identities. Those whose realities do not map neatly onto recognized categories become epistemically illegible and thus excluded, even from inclusion efforts [10]. This risks reinforcing the very disparities that inclusion policies seek to remedy.
In clinical research, certain efforts to increase inclusivity may not achieve the desired outcomes and can sometimes worsen existing inequalities. For instance, mandating the inclusion of women may increase trial enrolment statistics without ensuring that data are disaggregated by sex or that results are analyzed in a gender-sensitive manner. Inclusion, in such cases, becomes a performance rather than a practice. This is not only a missed scientific opportunity but also an ethical failure.
This distinction between performative and substantive inclusion is central to our argument: representation without analytical or epistemic change leaves inequities intact. The recruitment process for clinical trials reflects biases that further marginalize specific populations. According to Dahne and Hawk, decentralized clinical trials, defined as “a clinical trial in which some or all of the trial activities are conducted remotely” [11], can either alleviate or exacerbate preexisting disparities, highlighting the need for strategies to ensure equitable access to participation [12]. Community-based initiatives, as reported by Ferguson et al., illustrate the role of nurse practitioners in bridging gaps between underserved populations and clinical research, suggesting that structural adjustments in trial recruitment could enhance inclusivity [13]. However, the overarching trend remains one where health research is predominantly driven by market-based motivations, often ignoring the needs of marginalized communities.
Structural barriers further complicate equitable participation in clinical research. Financial considerations significantly influence the scope and focus of clinical trials, and investigator-led studies often face resource limitations [14]. Blümle et al. observed that commercial trials may achieve higher visibility and publication rates compared to noncommercial initiatives [15]. This reality often results in a skewed prioritization of research agendas, privileging profitability over public health needs.
The Danish case reflects this pattern. Despite leading in per capita trial numbers and investing in research infrastructure, clinical trial portfolios remain clustered around commercially prioritized conditions. Inclusion, while present in strategy documents and policy rhetoric, has yet to translate into the structural and epistemic shifts required for a more meaningful justice in knowledge production. As long as the inclusion of underrepresented groups remains a procedural formality, rather than a critical reorientation of research agendas, the disparities in who benefits from clinical research will continue to persist. Inclusion risks becoming performative: visible enough to satisfy policy requirements and insufficient to challenge underlying epistemic hierarchies.
Epistemic injustice in clinical research
Beyond procedural deficits in inclusion lies a deeper structural concern: the epistemic foundations of clinical research continue to exclude certain populations by rendering them invisible, illegible, or irrelevant. The concept of epistemic injustice allows us to link inclusion failures not only to who is recruited but also to whose knowledge is recognized as valid in shaping inclusion practices.
Philosopher Miranda Fricker defines epistemic injustice as wronging someone in their capacity as a knower, through credibility deficits (testimonial injustice) or a lack of interpretive tools (hermeneutical injustice) [16]. Initially framed at the interpersonal level, Fricker later acknowledged a broader category, discriminatory epistemic injustice, and recognized distributive dimensions, where access to education or knowledge is unequally shared [17]. Elizabeth Anderson extends this to the institutional scale [18]. She argues that virtue-based individual remedies cannot reliably address unconscious bias, and that not all injustices arise from prejudice. Structural factors—unequal access to credibility markers, ethnocentrism, and shared reality bias—can generate testimonial injustice without intentional discrimination. Addressing such causes requires structural solutions, not only individual goodwill.
Healthcare-specific epistemic injustice, as described by Carel and Kidd [19], offers another lens. Illness often undermines perceptions of credibility: the “ideal knower” is calm, detached, and rational; traits are difficult to display when in pain. Patients may be dismissed as irrelevant or overly emotional, particularly when their narratives are anecdotal or expressive rather than “clinically concise.” In clinical research contexts, this dynamic can strip patient testimony of epistemic value, further marginalizing those whose illness experiences could improve study design and outcomes.
In clinical research, these injustices manifest not only through exclusion from participation but also through exclusion from the conceptual frameworks that define disease, evidence, and relevance. The very idea of who counts as a legitimate research subject is shaped by historical and systemic inequalities. In clinical trials, these inequalities are operationalized through rigid inclusion/exclusion criteria, narrowly defined categories, and dominant biomedical epistemologies that tend to privilege homogeneity, predictability, and statistical legibility over diversity, complexity, and relationality.
The result is a clinical research ecosystem that reproduces what Charles Mills has termed an epistemology of ignorance, a system that not only overlooks certain groups but also structurally produces ignorance about them [20]. For example, clinical trials often exclude pregnant individuals, children, older adults, individuals with multimorbidity, people with disabilities, or those with nonnormative identities, not because their participation is irrelevant but because their inclusion introduces complexity that challenges conventional clinical trial designs.
Yet, these populations may stand to benefit most from clinical innovation. By systematically excluding them, clinical research institutions deny both their epistemic contributions and the development of evidence relevant to real-world care. The consequences are tangible: reduced generalizability, unsafe extrapolation, and the persistence of mistrust among communities historically mistreated or ignored by clinical research, such as racialized populations, LGBTQ+ individuals, or those with disabilities [21]. This in turn makes recruitment more difficult, reinforcing a vicious cycle of exclusion, invisibility, and inequity. Further, some groups suffer a more profound invisibility: they are not only excluded but also remain unrecognized as excluded. This form of hermeneutical injustice occurs when no conceptual or data infrastructure exists to register their absence [16]. Transgender individuals, for instance, remain largely invisible in trial reporting because gender identity is rarely collected in meaningful ways [22]. Without data, the absence is normalized, and exclusion persists unchallenged.
Even when inclusion does occur, it may be extractive. Participants from underrepresented populations may be treated as data sources without meaningful engagement, recognition, or benefit-sharing. Such tokenism allows institutions to meet regulatory expectations while leaving power structures unchanged. As epistemologist Kristie Dotson argues, this constitutes epistemic oppression: a systematic exclusion from participation in the production of knowledge that governs one’s own life [23].
Together, these dynamics demonstrate that achieving inclusive recruitment targets does not translate into substantial inclusion or structural changes if epistemic authority remains concentrated and unexamined. What is needed is a shift in how inclusion is conceptualized, not as a technical adjustment to trial design but as a political and epistemological commitment to equity. Underrepresented populations bring not only different vulnerabilities but also distinct forms of expertise. Clinical research must recognize them as epistemic agents, not merely study objects.
Toward just and reflective inclusion
If inclusion in clinical research is to be more than symbolic, it must be reconceptualized not as a numerical endpoint but as a dynamic and reflective process rooted in justice. This means moving beyond representational metrics and toward deeper questions of legibility, power, and participation: who is seen, who is heard, and who benefits? This section suggests what a justice-oriented model of inclusion resembles in practice and how it differs from prevailing compliance-driven approaches. Just inclusion requires a paradigm shift, from diversification of data to equity in epistemic contribution [24]. The key question is not only who is included but also who shapes the questions, methods, and standards of evidence.
Inclusion strategies should not merely aim to include underrepresented populations into preexisting frameworks but must actively reshape those frameworks to recognize alternative ways of knowing, experiencing illness, and engaging with healthcare. The goal is not simply to “add diversity” but to co-create knowledge with groups that have historically been excluded or ignored. These reframing positions inclusion as a transformation of clinical research agendas and epistemic norms, rather than an adjustment at the point of recruitment. This entails a structural commitment to participation beyond recruitment [25].
Clinical research must offer spaces where participants are engaged as contributors, consulted not only on consent forms and eligibility criteria but also on study priorities, outcome measures, and ethical oversight [26]. Such engagement should be ongoing, embedded, and adequately resourced, regarded as an institutional responsibility rather than an optional enhancement.
Including community representatives in research governance structures and decision-making bodies is one essential step. Moreover, ethical standards for trial inclusion must be expanded to incorporate principles of epistemic justice. This involves recognizing the authority of patient groups as “knowers,” validating experiential knowledge alongside biomedical expertise, and enabling these groups to help define what good evidence looks like in their contexts [17, 19].
Equity-oriented frameworks, such as co-design and participatory action research, may help institutionalize this shift [27, 28]. In the Danish case, this means leveraging its strong clinical research infrastructure and political momentum not only to attract industry-sponsored trials that ensure timely patient access to innovative therapies but also to assume leadership in rebalancing whose bodies and voices shape the future of medicine. Inclusion must be reimagined not as an obligation to fulfill but as an opportunity to correct entrenched inequities in evidence generation and healthcare delivery.
As efforts to diversify clinical research continue across Europe, just inclusion offers a positive direction. It requires humility, accountability, and an active redistribution of epistemic authority. Only then can inclusion become a pathway not just to better science, but to better health, shared more equitably across all patient populations. Importantly, justice-oriented inclusion does not imply that all populations must be included in all clinical trials; rather, exclusions should be ethically justified, transparent, and reflectively examined. Equity lies in accountability, not in indiscriminate representation.
Are we READI? From critique to practice
Past initiatives have frequently struggled with many of the above persistent tensions: the challenge of engaging hard-to-reach populations in ways that are meaningful rather than symbolic, the risk of flattening richly diverse lived experiences into reductive demographic categories, and the tendency to perpetuate invisibility by focusing on usual suspect populations already named in regulatory mandates while leaving other underserved populations unacknowledged.
The Research in Europe and Diversity Inclusion (READI) project is a public–private partnership funded by the Horizon Europe Innovative Health Initiative (IHI) and other funders. It is consciously positioned within a long and complex history of efforts to improve inclusion in clinical research in Europe [29]. The READI consortium aims to create a patient-centered, inclusive clinical study ecosystem in Europe by connecting stakeholders, providing training, breaking down barriers to participation, and then co-creating new methodological approaches, resources, training programs, and tools to advance this transformation.
READI is best understood as a response to the epistemic and structural problems identified throughout this commentary. Rather than focusing solely on numeric representation, we aim for justice-based inclusion. This involves valuing lived experiences, identifying structural barriers, and recognizing that not all health aspects or identities need to be included in clinical research. Our goal is not blind inclusion but an ethically grounded, context-sensitive approach that respects the communities shaping the future of equitable clinical research.
Conclusion
Denmark’s leadership in clinical trials in Europe is a significant scientific and political achievement. Yet, high volume does not equate to high equity. Concentrated disease priorities, limited demographic analysis, and exclusionary clinical trial designs perpetuate epistemic injustice, denying underrepresented and underserved populations the benefits of clinical research and the recognition of their knowledge. The challenge is not merely to enrol more diverse participants in existing systems but to transform ecosystems across Europe so that inclusion becomes a practice of shared epistemic responsibility. True leadership in clinical research will be measured not by the number of clinical trials conducted but by those whose health improves and whose knowledge counts. Inclusivity in clinical research is not an act of generosity; it is a condition for robust, generalizable, and trustworthy science. Aging, illness, and disability are not peripheral experiences; they are universal human prospects. If clinical research claims to speak for humanity, it must learn to listen to all of it.
Acknowledgements
We sincerely thank all members of the READI consortium for their commitment and expertise, which have been central to the development of this project.
Disclaimer
This publication is organized and funded by the consortium members in the IHI READI consortium.
This publication is intended for non-promotional scientific purposes only and may contain information on products or indications currently under investigation and/or that have not been approved by the regulatory authorities.
This publication is accurate at the time of presentation.
The content of this publication is not intended to establish any legally enforceable rights, obligations, or commitments on the IHI READI consortium members.
Authors’ contributions
UBK conceived the study, acquired funding, led the investigation, developed the methodology, wrote the original draft of, and critically revised the manuscript. NG contributed to the study conception, acquired funding, interpreted the data, and critically revised the manuscript. RH and PM contributed to funding acquisition, project administration, study supervision, and critically revised the manuscript. All authors read and approved the final manuscript.
Funding
Authors were not precluded from accessing data in the study, and they accept responsibility to submit for publication. This project is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement no. 101166227. The JU receives support from the European Union’s Horizon Europe research and innovation program and COCIR, EFPIA, EuropaBio, MedTech Europe, Vaccines Europe, and Medicines and Healthcare Products Regulatory Agency and Breakthrough T1D. This project is also supported by UKRI (UK Research and Innovation) under grant agreement no. 10152425 for National Institute for Health and Care Excellence and grant agreement no. 31052024 for The University Court of the University of Aberdeen.
Data availability
Not applicable.
Declarations
Ethics approval and consent to participate
Not applicable.
Consent for publication
Not applicable.
Competing interests
The authors declare no competing interests.
Footnotes
Throughout this text, we use the terms 'sex' and 'gender' in line with the original intent of the authors we cite, acknowledging that their interchangeable use is itself part of the conceptual and methodological problem we seek to address.
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Data Availability Statement
Not applicable.