Stakeholder views on participant selection for first-in-human trials in cancer nanomedicine

Current oncology

B.S. Elger¹  P. Satalkar¹  D.M. Shaw¹ 

[1] Institute for Biomedical Ethics

关键词: First-in-human trials;    trial participant selection;    nanomedicine;    qualitative research;    empirical ethics;   

DOI  :  10.3747/co.23.3214

学科分类：肿瘤学

来源: Multimed, Inc.

【 摘 要 】

Background Participant selection for first-in-human (fih) trials involves complex decisions. The trial design makes it unlikely that participants will receive clinically relevant therapeutic benefit, but they are likely to experience risks of various magnitudes and types. The  aim of the present paper was to describe and discuss the views of investigators and ethics committee members about the choice of trial participants for fih trials in cancer nanomedicine. MethodsWe drew insights from an exploratory qualitative study involving thematic analysis of 46 in-depth interviews with key stakeholders in Europe and North America involved in fih nanomedicine trials. The present work draws on subset of 21 interviews with investigators and ethics committee members who have either conducted or reviewed a fih cancer nanomedicine trial or are planning one. Results Investigators and ethics committee members are aware of the ethics standards for recruiting patients with end-stage cancer into fih trials, but they nonetheless question the practice and provide reasons against it. Conclusions Although it is a standard and ethically accepted practice to enrol patients with end-stage cancer and no treatment options into fih trials of investigational chemotherapeutic molecules, doing so can threaten the validity and generalizability of the trials, thereby weakening translational research. Another possibility is to stratify and include patients with less advanced disease who demonstrate certain biomarkers or cancer genotypes and who have a disease profile similar to that tested in preclinical studies. The latter approach could be a step toward personalized medical research and targeted drug development. Such a patient selection approach requires multi-stakeholder discussion to reach scientific and ethics consensus.

【 授权许可】

Unknown