克服障碍，促进多中心再生医学临床试验的监管。
Overcoming barriers to facilitate the regulation of multi-centre regenerative medicine clinical trials.
机构信息
Centre of Genomics and Policy, Department of Human Genetics, McGill University, Montreal, QC, H3A 0G1, Canada.
CellCAN, Pavillon Rachel-Tourigny RT2101, Montreal, QC, H1T 2M4, Canada.
出版信息
Stem Cell Res Ther. 2018 Nov 8;9(1):307. doi: 10.1186/s13287-018-1055-2.
Abstract
In the context of regenerative medicine and cellular therapies, the treatment under study often targets a less common disease or condition for which recruitment of a large number of research participants at any given site is challenging, if not impossible. One way to overcome this challenge is with a multi-centre clinical trial. This manuscript first aims to briefly outline the existing ethical, legal and social implications as well as the regulatory frameworks associated with multi-centre regenerative medicine clinical trials. Second, it considers the regulatory limitations and barriers surrounding the initiation of such trials in Canada, the USA and Europe. Third, it concludes with a set of recommendations for facilitating multi-centre clinical trials, at both national and international levels.
摘要
在再生医学和细胞疗法的背景下，所研究的治疗方法通常针对一种不太常见的疾病或病症，在任何给定的地点，招募大量的研究参与者是具有挑战性的，如果不是不可能的话。克服这一挑战的一种方法是进行多中心临床试验。本文首先旨在简要概述与多中心再生医学临床试验相关的现有伦理、法律和社会影响以及监管框架。其次，考虑了在加拿大、美国和欧洲启动此类试验所面临的监管限制和障碍。第三，最后提出了在国家和国际层面促进多中心临床试验的建议。
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