中国企业研发的3种COVID-19疫苗的95项临床试验的发表情况:观察性队列研究

Till Bruckner, Yixuan Chen, Carolina Cruz, Christie Ebube Dike, Belen Chavarria, Shiyu Chen, Ernest Dela Dzidzornu
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摘要

透明度不足会削弱人们对疫苗安全性和有效性的信心。本研究评估了由中国公司开发的 3 种 COVID-19 疫苗的 95 项临床试验的公布情况,这些疫苗已获得世界卫生组织的紧急使用许可 (EUL),并已在全球上市。我们检索了试验登记册和科学文献,以评估当前的试验状态和结果的公开性。在排除了 2 项撤销的试验后,我们发现至少有 62/93 项试验(67%)(涉及 307933 名患者)已经完成或终止。在这 62 项试验中,只有 44 项(71%)在同行评议期刊上发表了结果;没有一项试验的结果汇总表可在试验登记册上查阅。18/62(29%)项经核实已完成或终止的试验结果仍未公布。试验登记表中的试验状态信息往往不正确。我们的研究结果表明,这三家中国公司的信息披露实践与全球最佳实践基准之间存在巨大差距。如果中国的法律信息披露要求与更成熟的市场相一致,或者中国企业自愿采用更强的透明度实践,那么中国生物制药产品的透明度和全球公众对中国生物制药产品的信任度都会得到提高。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Publication status of 95 clinical trials of 3 COVID-19 vaccines developed by Chinese companies: An observational cohort study
Transparency shortcomings can undermine confidence in the safety and efficacy of vaccines. This study assesses the publication status of 95 clinical trials of 3 COVID-19 vaccines developed by Chinese companies that received a World Health Organization Emergency Use Listing (EUL) and have been marketed globally. We searched trial registries and the scientific literature to assess current trial status and the public availability of results. After excluding 2 withdrawn trials, we found that at least 62/93 trials (67%) involving 307,933 patients had verifiably been completed or terminated. Only 44 of those 62 trials (71%) had published results in a peer-reviewed journal; none had tabular summary results available on a trial registry. The results of 18/62 (29%) verifiably completed or terminated trials remained unpublished. The trial status information stated in trial registries was often incorrect. Our findings reveal a substantial gap between the disclosure practices of the 3 Chinese companies and global best practice benchmarks. Transparency and global public trust in Chinese biopharmaceutical products could be improved by aligning Chinese legal disclosure requirements with those prevalent in more mature markets, or by the voluntary adoption of stronger transparency practices by Chinese companies.
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