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Evaluating the Strategies on Ethical Grounds for Phase 0 Oncology Clinical Trials
Gupta, Umesh Chandra Mishra, Shivakant Bhatia, Sandeep Rajul, Rastogi
Gupta, Umesh Chandra
Mishra, Shivakant
Bhatia, Sandeep
Rajul, Rastogi
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EvalStatCT.pdf
Adobe PDF, 1.27 MB
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Abstract
Since the release of Exploratory IND guidance by FDA, phase 0 clinical trials have been criticized on many ethical grounds. Ethical concerns associated with phase 0 clinical trials include patients’ recruitment without any therapeutic benefit, delay in treatment and delay for participation in other clinical trials, therapeutic misconception, invasive biopsy procedures, and risks of research-related interventions. Various approaches have been identified to enhance the ethical stature of these trials but still there is need felt for newer approaches to develop an effective ethical agenda for phase 0 clinical studies. This article provides newer insights and perspectives on phase 0 ethics and explores the various ethical concerns, with distinction from each others, involved in phase 0 trials, and put forward a critical review and ethical agenda of the best possible approaches for enhancing the ethical stature of phase 0 oncology clinical trials.
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2011
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Creative Commons Copyright (CC 2.5)