Co-evolution of science and ethics in the clinical translation of nanocarriers for oncology: A perspective.

The journey of advanced nanomaterials, including nanocarrier-based therapeutics, has significantly transformed oncology by improving drug targeting, therapeutic delivery, biodistribution, and efficacy. However, the rapid clinical transition of emerging nanotechnology into clinical practice has introduced bioethical, regulatory, and social challenges that extend beyond the conventional biomedical paradigm. The current perspective argues that applying traditional bioethical principles, such as respect for persons, beneficence, non-maleficence, and justice, is challenged by the unique physicochemical characteristics of nanocarriers during the clinical transition from bench to bedside. Key issues discussed are informed consent, patient understanding, long-term safety, equitable accessibility, accountability, regulatory oversight, and post-marketing surveillance. In addition, the discussion proposes a co-responsibility approach in which patients, researchers, clinicians, industry regulatory authorities, and society collectively participate in the ethical transition process. Moreover, a co-evolutionary approach is suggested, in which innovation, ethics, regulation, and clinical applications will develop together.