Journal of Clinical Research & Bioethics

Abstract

Evaluating the Strategies on Ethical Grounds for Phase 0 Oncology Clinical Trials

Umesh Chandra Gupta, Shivakant Mishra, Sandeep Bhatia, Rastogi Rajul and Amit Sharma

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.