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...
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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Springer
2024-11-01
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| Series: | Holistic Integrative Oncology |
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| Online Access: | https://doi.org/10.1007/s44178-024-00126-4 |
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| _version_ | 1846147345011441664 |
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| author | Xiaoling Liu Zhengbo Song Shuting Tang Zhaochen Wang Ji Zhu |
| author_facet | Xiaoling Liu Zhengbo Song Shuting Tang Zhaochen Wang Ji Zhu |
| author_sort | Xiaoling Liu |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-3fc0d0f254144c308350f76c46ef84a5 |
| institution | Kabale University |
| issn | 2731-4529 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Springer |
| record_format | Article |
| series | Holistic Integrative Oncology |
| spelling | doaj-art-3fc0d0f254144c308350f76c46ef84a52024-12-01T12:50:13ZengSpringerHolistic Integrative Oncology2731-45292024-11-01311810.1007/s44178-024-00126-4Ethical reflections on phase I clinical trials of anticancer drugs: from a Chinese IRB’s empirical perspectiveXiaoling Liu0Zhengbo Song1Shuting Tang2Zhaochen Wang3Ji Zhu4The Medical Ethics Office, Zhejiang Cancer HospitalThe Phase I Clinical Trial Ward, Zhejiang Cancer HospitalThe Medical Ethics Office, Zhejiang Cancer HospitalCenter for Bioethics, Chinese Academy of Medical Sciences and Peking Union Medical CollegeThe Institutional Review Board, Zhejiang Cancer HospitalAbstract 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.https://doi.org/10.1007/s44178-024-00126-4Anticancer drugsPhase I clinical trialsEthical reviewResearch participant protection |
| spellingShingle | Xiaoling Liu Zhengbo Song Shuting Tang Zhaochen Wang Ji Zhu Ethical reflections on phase I clinical trials of anticancer drugs: from a Chinese IRB’s empirical perspective Holistic Integrative Oncology Anticancer drugs Phase I clinical trials Ethical review Research participant protection |
| title | Ethical reflections on phase I clinical trials of anticancer drugs: from a Chinese IRB’s empirical perspective |
| title_full | Ethical reflections on phase I clinical trials of anticancer drugs: from a Chinese IRB’s empirical perspective |
| title_fullStr | Ethical reflections on phase I clinical trials of anticancer drugs: from a Chinese IRB’s empirical perspective |
| title_full_unstemmed | Ethical reflections on phase I clinical trials of anticancer drugs: from a Chinese IRB’s empirical perspective |
| title_short | Ethical reflections on phase I clinical trials of anticancer drugs: from a Chinese IRB’s empirical perspective |
| title_sort | ethical reflections on phase i clinical trials of anticancer drugs from a chinese irb s empirical perspective |
| topic | Anticancer drugs Phase I clinical trials Ethical review Research participant protection |
| url | https://doi.org/10.1007/s44178-024-00126-4 |
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