| Autor: |
Huiyao Huang, Yu Tang, Yue Yu, Anqi Yu, Dawei Wu, Hong Fang, Shuhang Wang, Chao Sun, Xin Wang, Qi Fan, Yuan Fang, Qiyu Tang, Ning Jiang, Jingting Du, Huilei Miao, Ying Bai, Peiwen Ma, Shujun Xing, Dandan Cui, Shuangman Miao, Yale Jiang, Jingxiao Zhu, Qi Zhu, Ye Leng, Lan Wei Guo, Shanmei Liao, Yaguang Shao, Yinyin Song, Zeyuan Liu, Minghuang Hong, Suxia Luo, Binghe Xu, Gongtao Lan, Ning Li |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
|
| Zdroj: |
The Lancet Regional Health. Western Pacific, Vol 31, Iss , Pp 100624- (2023) |
| Druh dokumentu: |
article |
| ISSN: |
2666-6065 |
| DOI: |
10.1016/j.lanwpc.2022.100624 |
| Popis: |
Summary: Overall survival (OS) is considered the standard clinical endpoint to support effectiveness claims in new drug applications globally, particularly for lethal conditions such as cancer. However, the source and reliability of OS in the setting of clinical trials have seldom been doubted and discussed. This study first raised the common issue that data integrity and reliability are doubtful when we collect OS information or other time-to-event endpoints based solely on simple follow-up records by investigators without supporting material, especially since the 2019 COVID-19 pandemic. Then, two rounds of discussions with 30 Chinese experts were held and 12 potential source scenarios of three methods for obtaining the time of death of participants, including death certificate, death record and follow-up record, were sorted out and analysed. With a comprehensive assessment of the 12 scenarios by legitimacy, data reliability, data acquisition efficiency, difficulty of data acquisition, and coverage of participants, both short-term and long-term recommended sources, overall strategies and detailed measures for improving the integrity and reliability of death date are presented. In the short term, we suggest integrated sources such as public security systems made available to drug inspection centres appropriately as soon as possible to strengthen supervision. Death certificates provided by participants’ family members and detailed standard follow-up records are recommended to investigators as the two channels of mutual compensation, and the acquisition of supporting materials is encouraged as long as it is not prohibited legally. Moreover, we expect that the sharing of electronic medical records and the legal disclosure of death records in established health registries can be realized with the joint efforts of the whole industry in the long-term. The above proposed solutions are mainly based on the context of China and can also provide reference for other countries in the world. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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