Clinical Researcher—October 2026 (Volume 40, Issue 5)
PEER REVIEWED
Jeroze Dalal, PhD; Arghya Biswas, PhD
As the clinical research enterprise experiences structural transformation driven by a multitude of corporate and technological factors alongside growing public expectations, in this expert commentary, informed by experience across global clinical trial operations and research governance, we propose that contemporary clinical research education should prioritize three capability domains: ethics by design, governance-aware digital literacy, and meaningful patient partnership.
Ethical reflection should extend across study conception, operational design, and conduct. Digital fluency should encompass data integrity, regulatory implications, and limits of algorithmic inference. Patient partnership should be integrated across trial design and translation of evidence into practice.
We further illustrate how these domains may be operationalized through educational activities and governance-oriented approaches. Preparing researchers to steward trust—not merely execute protocols—is essential for sustaining credible and implementation-ready research systems.
Background
Examples of influences on structural transformation in the conduct of clinical trials include decentralized and hybrid trial models, real-world evidence (RWE) platforms, artificial intelligence (AI), and digitally mediated data flows that are reshaping how evidence is generated and evaluated.{1–4} Simultaneously, public expectations for transparency, equity, and patient partnership have intensified.{5,6} Research now operates within globally interconnected systems where methodological rigor, ethical accountability, technological governance, and lived experience intersect.
However, clinical research education has not evolved at a comparable pace. Across many graduate, diploma, and master’s programs, the core training remains anchored in regulatory compliance and technical proficiency, with limited structured engagement in decentralized trial operations, data governance literacy, or authentic patient co-production. Although health professional education reform has long emphasized systems thinking and professional formation,{7,8} translation into clinical research training has been uneven and variable.
Rather than implying that all curricula are deficient, this commentary focuses on three domains that merit explicit, systematic attention in contemporary programs: ethics by design, governance‑aware digital literacy, and meaningful patient partnership. As research ecosystems become more digital, distributed, and publicly scrutinized, the legitimacy of clinical research depends not only on methodological precision but also on the capacity of researchers to integrate these domains into study conception and execution.
Reframing clinical research education is therefore not incremental curricular adjustment; it is structural reform necessary to sustain trust in contemporary research systems. Investigator preparedness increasingly influences protocol feasibility, regulatory confidence, and implementation fidelity in decentralized and hybrid trial environments.
Ethics: From Compliance to Design Principle
Ethics in clinical research education is frequently introduced through regulatory requirements, institutional review processes, and foundational international ethics frameworks such as the Declaration of Helsinki.{6,9} While essential, this framing risks positioning ethics as procedural compliance rather than professional judgment embedded in study design.{10} Contemporary decentralized trials and RWE studies require anticipatory ethical judgment—ensuring meaningful electronic informed consent (eConsent) in remote contexts, safeguarding cross-jurisdictional data privacy, and addressing bias and inequity in real-world datasets.{1–3}
Contemporary training can further benefit from placing greater emphasis on ethical reflection throughout protocol conception, operational design, and study conduct rather than primarily at formal review milestones. This recommendation does not suggest that current protocol development lacks ethical consideration; rather, it recognizes emerging challenges associated with decentralized methods, digital technologies, and participant-centered design.
To illustrate how these capability domains may be translated into educational practice, Table 1 provides examples of corresponding learning activities and assessment approaches.
Table 1: Translating Capability Domains into Educational Practice
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Digital Literacy and Data Governance
Decentralized trials and digital analytics are increasingly integral to research ecosystems,{1–3} while regulatory reliance on RWE continues to expand.{3} Yet digital innovation introduces new epistemic and governance challenges (see Table 2). Heterogeneous data streams, eConsent platforms, remote monitoring, and algorithmic decision tools may compromise data integrity or amplify inequities if oversight is insufficient.{1–3}
Clinical research education should therefore cultivate governance-aware digital literacy as a core competency. Learners need to understand the limits of algorithmic inference, regulatory implications of digital endpoints, principles of data integrity (such as ALCOA+), and ethical risks embedded within large-scale data infrastructures and multi-jurisdictional data flows.{1–3} Such literacy moves beyond technological familiarity toward informed stewardship of complex data systems.
Without this capability, innovation may outpace oversight and introduce avoidable risks to data credibility, participant protection, and regulatory confidence. Positioning “digital and data governance literacy” as a defined curriculum domain helps programs respond to these realities without prescribing a single uniform model.
Table 2: Illustrative Governance Questions for Emerging Digital Research Approaches
| Digital Element | Illustrative Governance Question |
| eConsent | Is participant comprehension demonstrated rather than assumed? |
| Remote monitoring | Does access to technology create differential participation or introduce inequities? |
| Algorithmic decision tools | Can outputs be explained, validated, and appropriately overseen? |
| Real-world evidence (RWE) sources | Are data provenance, completeness, and potential sources of bias adequately assessed? |
| Heterogeneous data streams | Are data origin, integration methods, interoperability assumptions, and traceability sufficiently transparent to support data integrity and interpretation? |
Patients: From Subjects to Co-Creators
Patient and public involvement improves recruitment, retention, and research relevance.{5} Community engagement is also central to global research ethics frameworks, including the Declaration of Helsinki and World Health Organization guidance on public involvement.{9,11} These developments signal a shift in how research legitimacy is constructed—not solely through approval mechanisms, but through partnership.
However, engagement may remain focused on consultation or communication rather than deeper involvement in research design. Education can help move beyond this by preparing researchers to collaborate with patients as knowledge partners—co-defining research questions, shaping outcome selection, strengthening consent processes, and contributing to interpretation and dissemination.{5,11}
Embedding structured engagement opportunities into training environments helps position partnership as routine scientific practice rather than a late-stage enhancement activity. Explicit attention to “patient partnership co-production” as a curriculum focus can enhance methodological robustness while reinforcing ethical legitimacy, without assuming that all programs currently ignore this domain.
Systems Thinking as an Educational Foundation
Education reform literature emphasizes systems thinking, interprofessional collaboration, and integration across disciplines.{7,8} Clinical research education similarly needs to reflect the complexity of contemporary research systems. These recommendations complement established competency-based approaches such as the Joint Task Force for Clinical Trial Competency framework,{12} particularly in terms of its domains relating to ethical and participant safety considerations, leadership and professionalism, data management and informatics, and clinical trial operations. Rather than proposing replacement competencies, this commentary argues that contemporary research environments warrant more explicit integration of ethics-by-design thinking, governance-aware digital literacy, and meaningful patient partnership within existing educational structures.
Trial design intersects with regulatory frameworks, digital infrastructures, health service delivery, funding mechanisms, and public accountability. Rather than compartmentalizing methodology, ethics, and regulation, curricula can illuminate their interdependence. Design decisions influence feasibility, equity, regulatory review, implementation, and public perception. Case-based learning, exposure to decentralized and hybrid trial examples, and interdisciplinary engagement support professional formation rather than technical instruction alone and strengthen protocol feasibility in real-world delivery environments.{7,10}
Systems thinking thus becomes a practical competency—enabling researchers to anticipate downstream implications and navigate complexity responsibly. The three domains highlighted above provide concrete organizing foci for curriculum development.
Delivery should occur across complementary settings, including academic programs, sponsor and contract research organization training, site-based development initiatives, and continuing professional education.{13} Foundational concepts may be introduced centrally, while protocol-specific application should occur within operational settings.
Relevance Across Contexts
Global research expansion underscores the importance of embedding ethics and governance within research capacity-building efforts.{6,11} Training focused narrowly on procedural compliance may be insufficient to address contextual relevance and equity, particularly across settings with varying infrastructure, health-system capacity, and digital access.{6,11}
Educational models must cultivate sensitivity to infrastructure variability, digital access disparities, and local health priorities. Researchers should be prepared to align study design with community needs, ensure equitable participant inclusion, and recognize structural power asymmetries in global collaborations.{11} Framing ethics by design, governance-aware digital literacy, and patient partnership as adaptable domains allows programs in diverse contexts to tailor content while working toward shared aims of trustworthy and context-appropriate research.
Educating for Trust, Not Just Trials
Clinical research ultimately derives its legitimacy from public trust. Methodological rigor remains essential, but credibility increasingly depends on whether studies are feasible to deliver, acceptable to participants, and aligned with real-world health priorities.{5,11,13} As trials become more decentralized and data-intensive, investigator preparedness across ethics, governance, and partnership domains becomes directly relevant to trial quality and implementation readiness.
Reframing clinical research education around ethics by design, governance-aware digital fluency, and authentic patient co-production is therefore best viewed as a forward-looking priority rather than a critique of existing programs. Graduate training should prepare researchers not merely to execute protocols but to support reliable trial delivery, data credibility, and regulatory-grade evidence generation. In an era defined by decentralization, data expansion, and heightened public scrutiny, educating for trust is not aspirational; it is foundational to the future credibility of clinical research.
Disclaimers
The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of their current or former employers. This commentary reflects professional perspectives informed by experience in clinical research education and practice and is intended to stimulate discussion on evolving approaches to clinical research training.
References
- U.S. Food and Drug Administration. 2024. Conducting Clinical Trials with Decentralized Elements: Guidance for Industry, Investigators, and Other Interested Parties. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-clinical-trials-decentralized-elements
- International Council for Harmonisation. 2025. ICH Harmonised Guideline E6(R3): Guideline for Good Clinical Practice.
- European Medicines Agency. 2020. Regulatory Science to 2025: Strategic Reflection.
- Izmailova ES, Ellis R, Benko C. 2020. Remote monitoring in clinical trials during the COVID-19 pandemic. Clin Transl Sci 13(5):838–41.
- Crocker JC, Ricci-Cabello I, Parker A, et al. 2018. Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis. BMJ 363:k4738.
- Emanuel EJ, Wendler D, Grady C. 2000. What makes clinical research ethical? JAMA 283(20):2701–11.
- Frenk J, Chen L, Bhutta ZA, et al. 2010. Health professionals for a new century: transforming education to strengthen health systems in an interdependent world. Lancet 376(9756):1923–58.
- Irby DM, Cooke M, O’Brien BC. 2010. Calls for reform of medical education by the Carnegie Foundation for the Advancement of Teaching: 1910 and 2010. Acad Med 85(2):220–7.
- World Medical Association. 2024. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants (Revised).
- Cooke M, Irby DM, O’Brien BC. 2010. Educating Physicians: A Call for Reform of Medical School and Residency. San Francisco: Jossey-Bass.
- World Health Organization. 2024. Guidance for best practices for clinical trials. https://www.who.int/publications/i/item/9789240097711
- Sonstein SA, Jones CT. 2018. Joint Task Force for Clinical Trial Competency and Clinical Research Professional Workforce Development. Front Pharmacol 9:1148.
- Macleod M, Michie S, Roberts I, et al. 2014. Biomedical research: increasing value, reducing waste. The Lancet 383:101–4.
Jeroze Dalal, PhD, is an independent healthcare consultant in India and former Head of Clinical Operations, Governance, and Risk Management for GlaxoSmithKline Pharmaceuticals.
Arghya Biswas, PhD, is a Senior Clinical Project Lead in the pharmaceutical industry, based in Copenhagen, Denmark. He has 17 years of experience in global clinical operations and evidence generation, including decentralized trials and real-world evidence. His experience also includes digital health, clinical research quality, and training and mentoring clinical research professionals.
