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Overcoming barriers to facilitate the regulation of multi-centre regenerative medicine clinical trials.
- Source :
-
Stem cell research & therapy [Stem Cell Res Ther] 2018 Nov 08; Vol. 9 (1), pp. 307. Date of Electronic Publication: 2018 Nov 08. - Publication Year :
- 2018
-
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.
Details
- Language :
- English
- ISSN :
- 1757-6512
- Volume :
- 9
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Stem cell research & therapy
- Publication Type :
- Academic Journal
- Accession number :
- 30409192
- Full Text :
- https://doi.org/10.1186/s13287-018-1055-2