Ethical reflections on phase I clinical trials of anticancer drugs: from a Chinese IRB’s empirical perspective

Abstract

Purpose

With the rapid development of Phase I clinical trials for anticancer drugs in China, addressing ethical concerns is imperative. In order to safeguard the rights, interests, and well-being of research participants, this paper aims to illustrate vital ethical issues that should not be neglected by institutional review boards as well as other relevant stakeholders for Phase I clinical trials of anticancer drugs.

Methods

This study retrospectively collects documents on Phase I clinical trials for anticancer drugs that were submitted to the Institutional Review Board at Zhejiang Cancer Hospital from 2021 to 2023. Based on Chinese and international research regulations and guidelines, these documents, as well as initial and follow-up review resolutions, have been classified and analyzed.

Results

Given the additional risks of potentially toxic effects in Phase I clinical trials for anticancer drugs and the vulnerability of participants enrolled with advanced cancer status, it is important to review investigator qualifications, preliminary findings, research methods, inclusion and exclusion criteria in the protocol, as well as the validity and readability of informed consent. Additionally, attention should be given to follow-up reviews, particularly regarding safety reports and protocol deviations.

Conclusion

To effectively protect the rights, interests and safety of research participants. Relevant stakeholders, including sponsors, researchers, and regulatory bodies, should diligently evaluate potential risks and provision contingency plan to minimize the latent risk.