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

Satalkar, Priya and Elger, Bernice Simone and Shaw, David.. (2016) Stakeholder views on participant selection for first-in-human trials in cancer nanomedicine. Current Oncology, 26 (6). e530-e537.

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Official URL: http://edoc.unibas.ch/52213/

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Abstract

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. Methods We 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. 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. Methods We 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.
Faculties and Departments:08 Cross-disciplinary Subjects > Ethik > Institut für Bio- und Medizinethik > Bio- und Medizinethik (Elger)
03 Faculty of Medicine > Departement Public Health > Ethik in der Medizin > Bio- und Medizinethik (Elger)
UniBasel Contributors:Satalkar, Priya and Elger, Bernice Simone and Shaw, David
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Multimed
ISSN:1198-0052
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:06 Oct 2017 10:15
Deposited On:06 Oct 2017 10:15

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