Ethical considerations in phase I clinical trials.
Medical ethics has developed methods of differential ethics for a more rigid integration of bioethical reasoning into biomedical research. Due to high levels of risk and uncertainty in phase I trials, established principles of medical ethics need a specific assessment in order to provide for better moral design and moral monitoring of trial procedures, a better translation of medical health status data into individual quality of life criteria, and strong support for trust-based cooperation between physician, research team and patient. Existing bioethical questionnaires and detailed methodological research in differential ethics could be improved further.
Kennedy Institute of Ethics, Georgetown University, Washington, DC.
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D000970:Antineoplastic Agents / Q000009:adverse effects; D032781:Codes of Ethics; D004341:Drug Evaluation / Q000379:methods*; D026724:Ethical Review; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D006805:Human Experimentation; D006801:Humans; D018579:Patient Selection; D035842:Research Subjects; D018570:Risk Assessment; D012307:Risk Factors; D035501:Uncertainty
D000970:Antineoplastic Agents