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Ethical Considerations for Phase I Trials in Oncology
Merlin Bittlinger1, Selin Bicer1, Jeffrey Peppercorn2
1Studies of Translation, Ethics and Medicine (STREAM), Department of Equity, Ethics and Policy, McGill University, Montreal, Quebec, Canada.
Summary
Phase I cancer trials face ethical challenges due to high research burden, patient vulnerability, and impact on drug development. Recommendations address design, consent, and reporting for improved ethical conduct in early-phase cancer research.
Area of Science:
- Oncology
- Clinical Trials
- Bioethics
Background:
- Phase I cancer trials are the initial human testing of novel therapeutic strategies.
- Ethical considerations in these trials are evolving due to advancements in cancer biology, research methodologies, regulatory frameworks, and medical ethics.
Purpose of the Study:
- To conduct a narrative review of current ethical challenges in the design, execution, and reporting of phase I cancer trials.
- To propose recommendations for addressing identified ethical issues.
Main Methods:
- A narrative review approach was employed.
- Scoping reviews supplemented the analysis of benefit/risk, research biopsies, and therapeutic misconception.
- The review focused on four key areas: benefit/risk, research biopsies, therapeutic misconception and misestimation, and reporting.
Main Results:
- Key ethical challenges arise from the significant research burden and scientific uncertainty inherent in phase I trials.
- Patients often enter phase I trials after exhausting standard treatments, facing critical illness points.
- Phase I trial outcomes significantly influence subsequent drug development and regulatory approvals.
Conclusions:
- Contemporary ethical challenges in phase I cancer trials are multifaceted, influenced by scientific, patient, and regulatory factors.
- Recommendations are provided for enhancing ethical review, informed consent, trial design, and reporting practices.
- Further research is needed to address unresolved ethical questions and strengthen the foundation of early-phase cancer research.
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