Abstract
As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues. As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 427-430 |
| Number of pages | 4 |
| Journal | Cell Stem Cell |
| Volume | 21 |
| Issue number | 4 |
| DOIs |
|
| State | Published - Oct 5 2017 |
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Keywords
- benefit-risk assessment
- clinical trials
- efficacy
- genome editing
- off-target effects
- regulations
- safety
ASJC Scopus subject areas
- Molecular Medicine
- Genetics
- Cell Biology
Cite this
Human Genome Editing in the Clinic : New Challenges in Regulatory Benefit-Risk Assessment. / Abou-El-Enein, Mohamed; Cathomen, Toni; Ivics, Zoltán; June, Carl H.; Renner, Matthias; Schneider, Christian K.; Bauer, Gerhard.
In: Cell Stem Cell, Vol. 21, No. 4, 05.10.2017, p. 427-430.Research output: Contribution to journal › Comment/debate
}
TY - JOUR
T1 - Human Genome Editing in the Clinic
T2 - New Challenges in Regulatory Benefit-Risk Assessment
AU - Abou-El-Enein, Mohamed
AU - Cathomen, Toni
AU - Ivics, Zoltán
AU - June, Carl H.
AU - Renner, Matthias
AU - Schneider, Christian K.
AU - Bauer, Gerhard
PY - 2017/10/5
Y1 - 2017/10/5
N2 - As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues. As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues.
AB - As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues. As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues.
KW - benefit-risk assessment
KW - clinical trials
KW - efficacy
KW - genome editing
KW - off-target effects
KW - regulations
KW - safety
UR - http://www.scopus.com/inward/record.url?scp=85030462516&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85030462516&partnerID=8YFLogxK
U2 - 10.1016/j.stem.2017.09.007
DO - 10.1016/j.stem.2017.09.007
M3 - Comment/debate
C2 - 28985524
AN - SCOPUS:85030462516
VL - 21
SP - 427
EP - 430
JO - Cell Stem Cell
JF - Cell Stem Cell
SN - 1934-5909
IS - 4
ER -