Letter to the Editor of the British Journal of Clinical Pharmacology Re: van Iersel et al. (2026)—Why do healthy volunteers participate in clinical trials? doi: https://doi.org/10.1002/bcp.70499

1.

Dear editor,

Van Iersel et al ¹ are to be commended for their important contribution towards a deeper understanding of the motivations and needs of healthy volunteers participating in early‐phase (phase I) clinical trials. Their findings demonstrate that participation is driven by a combination of altruistic, practical and social factors, rather than financial compensation alone, while also highlighting healthy volunteers as an underutilized stakeholder group in early clinical development.

Building on these insights and informed by our experience in implementing a large and diverse early‐phase and clinical pharmacology portfolio at Novartis, we would like to encourage further expansion of this research in several areas:

First, we suggest exploring motivation patterns across a broader range of geographies, including the United States and regions outside the EU such as the United Kingdom and India, to better reflect cultural and socio‐economic diversity. This is particularly relevant given that medical check‐ups were identified as a key motivation for participation by 91% of respondents, a factor that may vary substantially depending on healthcare systems across regions. With an active portfolio of approximately 50 ongoing clinical pharmacology and first‐in‐human studies conducted in partnership with CROs in the EU, the United Kingdom, the United States and India, Novartis would be well positioned to contribute to such efforts.

Second, motivation should be examined in the context of increasingly frequent study designs that involve repeated outpatient visits over extended periods—for example, studies lasting up to a year for siRNA or long‐acting monoclonal antibodies—compared with small‐molecule studies that typically have shorter follow‐up durations. Understanding these differences could help CRUs adapt operational models to reduce participant burden and improve retention.

Third, we propose further investigation of altruistic motivation in relation to the perceived medical need of the indication under study, particularly in trials addressing serious diseases such as cancer or Alzheimer's disease. Such insights could inform more tailored and ethically grounded participant engagement strategies.

Finally, consistent with the findings published by Klein et al, ² this large European survey underscores both the willingness and readiness of healthy volunteers to engage more actively in early‐phase research. The authors rightly call for collaborative efforts among sponsors, investigators, ethics committees, regulators and participants to establish structured, ethical and practical frameworks for healthy participant engagement. We recognize the value of this vision and would be willing to discuss potential opportunities to contribute.

Sincerely,

Kasra Shakeri‐Nejad, MD

Markus Hinder, MD, PhD

AUTHOR CONTRIBUTIONS

All authors contributed to the conceptualization, review and approval of this letter.

CONFLICT OF INTEREST STATEMENT

Kasra Shakeri‐Nejad is an employee of Novartis, Basel, Switzerland. Markus Hinder is an employee of Novartis, Basel, Switzerland, a professor of the State of Hessen, Germany, and mandated lecturer at the University of Zürich, Switzerland.

DATA AVAILABILITY STATEMENT

Research data are not shared.