Abstract: Clinical trials are essential to both individual and collective healthcare. However, several ethical concerns have emerged from the analysis of accumulated experience and data, as well as the integration of diverse perspectives and voices. This communication aims to contribute to public awareness and discussion of these concerns and to the structural changes in the clinical trials ecosystem being currently advocated.
 
Keywords: Clinical Trials, Health, Participants, Human Right, Ethical, Accessibility, Equity, Diversity, Advocacy.
 
Content:
The International Council for Harmonisation's guideline for Good Clinical Practice (ICH-GCP) establishes an international ethical and scientific quality standard for human subject trials.[1] This guideline ensures the protection of the rights, safety, and well-being of trial participants, while also affirming the credibility of clinical trial data [1]. As per ICH-GCP, clinical trials are defined as a fundamental part of clinical research that support the development of new medicines or uses of existing medicines. Well-designed and conducted clinical trials help answer key questions in healthcare and drug development. Their results are essential for evidence-based healthcare decisions.[2] This definition highlights the traditional role of clinical trials in the development and evolution of medical care and science within society. Nevertheless, at the individual level, a patient's participation in a clinical trial designed to evaluate a personalized treatment or intervention can be life-saving and may even be considered a fundamental human right: the right to health. [3]
 
Clinical trials are therefore essential to both individual and collective healthcare and, in recent years, there has been an increasing volume of clinical trials conducted globally.[4] However, several ethical concerns have emerged from the analysis of accumulated experience and data, as well as the integration of diverse perspectives and voices. These concerns highlight the need for significant structural changes to the current clinical trials ecossystem.[5] 
 
Among these ethical concerns are inequities at multiple levels that generally relate to the why, who, how, when, and where the clinical trials were planned, conducted and regulated, and include:
• The unequal global distribution of conducted studies;
• The unequal distribution of benefits resulting from the outcomes of clinical trials among participants in the same trial after its conclusion;
• There is a limited capacity among non-commercial sponsors to conduct clinical trials, which are essential for their research and for providing better healthcare services;
• The underdevelopment of scientific research and knowledge regarding certain diseases and human populations;
• The unequal capacity of individuals to participate in trials is influenced by social determinants such as household income, employment status, education, ethnicity, and gender, as well as health system-related factors.[5,6]
 
The challenges and barriers identified within the global clinical trials ecosystem directly impact global health. It is urgent to establish new pathways, goals, and agendas for trial models that are more accessible, equitable, diverse, and cost effective. [4,5,6]
 
Actions are therefore required to promote:
• Subjects' participation and retention in patient-centered studies that consider the diverse characteristics of populations, generating meaningful, representative, and real outcomes for both participants and society;[7,8]
• Empowerment of healthcare professionals and institutions to conduct research studies as an integral part of healthcare services for patients and communities across various regions of the world;[5]
• Create financing and structural conditions to support the development of trials, promoted by a more diverse pool of sponsors and stakeholders. These trials should be scientifically driven and focused on advancing knowledge and new treatments within clinical practice, applicable to the populations they serve or represent;[9]
• Create conditions for testing new operational approaches to the development, approval, implementation, and conduct of clinical trials that are compliant with ICH-GCP guidelines and legal requirements. These approaches should more effectively align with participants' priorities, disease characteristics, protocol timelines, and available resources; [9]
• Promote the ongoing and open sharing of data, tools, and technology to maximize regulators' capacity to monitor, evaluate, and identify gaps, priorities, needs, and risks at various levels of the research ecosystem.[9]
 
Finally, specific challenges and barriers that limit clinical trials, must be thoroughly examined and understood, taking into account the unique disease and clinical context. Additionally, it is essential to consider the ongoing scientific advancements and ensure that newly acquired knowledge and clinical research, are adequately translated into effective and meaningful treatments for patients and communities all over the world. [10,11]
 
 
References
1. European Medicines Agency (n.d.). Good clinical practice | European Medicines Agency. www.ema.europa.eu2. Committee for Human Medicinal Products ICH E6 (R3) Guideline for good clinical practice (GCP). (2025). 3. Superchi, C., Bouvier, F.B., Gerardi, C., Carmona, M., Miguel, L.S., Sánchez-Gómez, L.M., Imaz Iglesia, I., Garcia, P., Demotes, J., Banzi, R. and Porcher, R. (2022). Study designs for clinical trials applied to personalised medicine: a scoping review. BMJ Open, [online] 12(5), p.e052926. doi: https://doi.org/10.1136/bmjopen-2021-0529264. Joshi, G., Bhandari, T.K., Joshi, P., Bhandari, S., Araveeti, S.R., Jain, A., Khadka, S., Trecarten, S., Abdelaziz, A., Garg, H. and Bhandari, M. (2025). The Current Landscape of Clinical Trials. Journal of Clinical Medicine, https://doi.org/10.3390/jcm14072519 [online]14(7),p.2519.5. Strengthening clinical trials 1 to provide high-quality evidence on health interventions and to improve research qualityand coordination. (n.d.). https://apps.who.int/gb/ebwha/pdf_files/WHA75/A75_R8-en.pdf 6. Kim, J.Y., Florez, M., Botto, E., Belgrave, X., Grace, C. and Getz, K. (2024). The influence of socioeconomic status on individual attitudes and experience with clinical trials. Communications Medicine.7. Barsha, R.A.A., Assari, S., Byiringiro, S., Michos, E.D., Plante, T.B., Miller, H.N., Himmelfarb, C.R. and Sheikhattari, P. (2025). Motivation to Clinical Trial Participation: Health Information Distrust and Healthcare Access as Explanatory Variables and Gender as Moderator. Journal of Clinical Medicine, [online] 14(2), p.485. doi: https://doi.org/10.3390/jcm140204858. Wahlstrom-Edwards, L. and Hess, A.-M. (2019). The patient perspective on clinical trials.www.appliedclinicaltrialsonline.com, [online] 28(3). Available https://www.appliedclinicaltrialsonline.com/view/patient-perspective-clinical-trials                                                                                                                                              9. Accelerating Clinical Trials in the EU. (2024). Accelerating clinical trials in the EU. [online] Available at: https://accelerating-clinical-trials.europa.eu/index_en10. Disorders, F. on N. and N.S., Policy, B. on H.S., Division, H. and M. and National Academies of Sciences, E. (2016). Neuroscience Clinical Trials: An Overview of Challenges and Potential Opportunities. [online] www.ncbi.nlm.nih.gov. National Academies Press (US). Available at: https://www.ncbi.nlm.nih.gov/books/NBK396103/11. Silvia Zaragoza Domingo, Alonso, J., Ferrer, M., Acosta, M.T., Alphs, L., Annas, P., Pavel Balabanov, Berger, A.-K., Bishop, K.I., Butlen-Ducuing, F., Georg Dorffner, Edgar, C., Manuel, Harel, B., Harrison, J., Horan, W.P., Jaeger, J., Kottner, J., Pinkham, A. and Tinoco, D. (2024). Methods for Neuroscience Drug Development: Guidance on Standardization of the Process for Defining Clinical Outcome Strategies in Clinical Trials. European Neuropsychopharmacology, 83, pp.32–42. doi: https://doi.org/10.1016/j.euroneuro.2024.02.009

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