Responsible Translation of Stem Cell Research: An Assessment of Clinical Trial Registration and Publications.
Responsible Translation of Stem Cell Research: An Assessment of Clinical Trial Registration and Publications.
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DOI：
10.1016/j.stemcr.2017.03.013
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发表时间：
2017-05-09
影响因子：
5.9
通讯作者：
Bubela T
中科院分区：
文献类型：
--
作者：
Fung M;Yuan Y;Atkins H;Shi Q;Bubela T
我们评估了创新的基于细胞的干预措施的临床试验结果的出版在多大程度上反映了国际干细胞研究学会最佳实践指南。我们评估了：（1）已完成试验的特征和发表时间;（2）报告试验的质量;（3）已发表试验的结果。我们识别并分析了1,052项新的干细胞临床试验的出版物：393项已完成的试验中有179项（45.4%）发表了结果; 48项试验由已知的干细胞旅游诊所注册，其中没有一项报告结果。完成的非行业赞助的试验最初发表得更快，但与行业赞助的试验的差异随着时间的推移而减少。大多数出版物报告了安全性，67.3%（主要是早期试验）报告了积极结局。较高比例的行业试验报告了积极的疗效。患者对干细胞疗法的期望提高了，这就产生了透明进行临床试验的道德义务。需要制定针对早期临床试验的报告指南。我们评估了创新的基于细胞的干预措施的临床试验出版物，只有54.5%的已完成的试验报告了结果已知提供未经证实的干细胞疗法的私人诊所注册“试验”需要试验报告指南，具体到早期临床试验Fung及其同事评估了新型干细胞疗法临床试验的出版模式。试验结果仍然被低估，干细胞旅游诊所正在推广他们的试验登记处的诊所活动。需要专门针对早期临床试验的临床试验报告指南。
We assessed the extent to which the publication of clinical trial results of innovative cell-based interventions reflects International Society for Stem Cell Research best practice guidelines. We assessed: (1) characteristics and time to publication of completed trials; (2) quality of reported trials; and (3) results of published trials. We identified and analyzed publications from 1,052 novel stem cell clinical trials: 179 (45.4%) of 393 completed trials had published results; 48 trials were registered by known stem cell tourism clinics, none of which reported results. Completed non-industry-sponsored trials initially published more rapidly, but differences with industry-sponsored trials decreased over time. Most publications reported safety, and 67.3% (mainly early-stage trials) reported positive outcomes. A higher proportion of industry trials reported positive efficacy. Heightened patient expectations for stem cell therapies give rise to ethical obligations for the transparent conduct of clinical trials. Reporting guidelines need to be developed that are specific to early-phase clinical trials. We assessed clinical trial publications of innovative cell-based interventions Only 54.5% of completed trials reported results Private clinics known to provide unproven stem cell therapies register “trials” Trial reporting guidelines are needed, specific to early-phase clinical trials Fung and colleagues assessed publication patterns of clinical trials of novel stem cell therapies. Trial results remain underreported and stem cell tourism clinics are promoting their clinic activities on trial registries. Clinical trial reporting guidelines specific to early-phase clinical trials are needed.