Emily Abdoler

The Ethics of Phase 0 Oncology Trials

Recent guidance from the Food and Drug Administration supports the conduct of a new type of exploratory clinical trial, commonly called phase 0 clinical trials. Proponents argue that phase 0 clinical trials have the potential to expedite the development of new oncology drugs while exposing fewer research subjects to the risks of experimental treatments. At the same time, phase 0 oncology trials raise important ethical concerns that have received little attention. In particular, there is a question of whether it is ethical to enroll individuals in research that offers them no potential for clinical benefit. Further concern focuses on the inclusion of terminally ill and consequently vulnerable cancer patients in these trials. To evaluate these concerns, this article considers relevant empirical data from phase 1 oncology trials and develops several recommendations regarding the conduct of phase 0 clinical trials in oncology.

Views of Adolescents and Parents on Pediatric Research Without the Potential for Clinical Benefit

OBJECTIVE: Critics argue that pediatric research without the potential for clinical benefit is unethical because it treats children as mere means, exposing those who cannot consent to risks for the benefit of others. The present survey was designed to assess whether this claim is consistent with the views of adolescents who actually participate in research, or their parents. METHODS: Interviews were conducted with adolescents participating in research at the NIH Clinical Center or Seattle Childrens Hospital, and their parents, from June 2008 through April 2010. RESULTS: Interviews were completed with 177 of 186 adolescent/parent pairs (response rate= 95.2%). Overall, 90% of the adolescents and parents were willing to have the adolescent undergo a few extra blood draws, and 65% were willing to have the adolescent undergo an extra skin biopsy, for research purposes. The vast majority felt that the adolescents were making an important contribution to help others, and 80.8% of the adolescents felt proud to be doing so. Respondents overall were equally willing to have the adolescent face risks to help others in a research study or in a charitable activity. CONCLUSIONS: The views and experiences of these respondents do not support the claim that pediatric research without the potential for clinical benefit treats subjects as mere means. Instead, the findings provide proof of principle for the claim that non-beneficial pediatric research involves a type of charitable activity which offers children the opportunity to contribute to a valuable project to help others.

Variability in student perceptions of mistreatment

As medical schools strive to improve the learning environment, it is important to understand medical students’ perceptions of mistreatment. The purpose of this study was to explore student interpretations of previously reported mistreatment incidents to better understand how they conceptualise the interactions.

‘Til Death Do Us Part: End-of-Life Experiences of Married Couples in a Nationally Representative Survey: End-of-life experiences in married couples

To determine whether end‐of‐life (EOL) experiences in the first spouse in a marriage are associated with EOL experiences in the other spouse.

NIH Ethics Education Programs and Initiatives: Training the Next Generation of Clinical and Translational Researchers.

A range of coursework in research ethics is available to medical students through the National Institutes of Health’s educational programs. Virtual Mentor is a monthly bioethics journal published by the American Medical Association.

Reply to the Letter to the Editor from Arai et al.

In Response: We agree that payment to phase 0 oncology trial participants must be carefully considered. However, to the extent that healthy volunteers are paid to participate in research that does not offer the prospect of direct benefit, the same modest incentives should be considered for cancer