Ethical issues in adult oncology randomized clinical trials

Author(s): Erika P Hamilton, Jeffrey M Peppercorn

Randomized clinical trials (RCTs) are essential to evaluate novel cancer interventions and to improve care and outcomes. Conducting clinical research in oncology conveys ethical obligations to safeguard the interests of research participants and to ensure that they are an informed partner in our efforts to improve cancer care. Core ethical requirements of oncology RCTs are: asking a good question and designing a trial that can answer it; ensuring the voluntary informed consent of participants; and promoting the safety and interest of research participants at all times. This article will review some of the major ethical issues that arise in the course of design, conduct and analysis of oncology RCTs.