How clean was the KLEAN trial?
P Bellman - The Lancet, 2006 - thelancet.com
1 Kenter MJH, Cohen AF. Establishing risk of human experimentation with drugs: lessons
from TGN1412. Lancet 2006; 368: 1387–91. 2 TeGenero Immunotherapeutics Investigator's …
from TGN1412. Lancet 2006; 368: 1387–91. 2 TeGenero Immunotherapeutics Investigator's …
Lessons from TGN1412
T Hanke - The Lancet, 2006 - thelancet.com
In their Viewpoint (Oct 14, p 1387), 1 Marcel Kenter and Adam Cohen criticise the
assessment of preclinical safety and mode-of-action data for TGN1412—an anti-CD28 …
assessment of preclinical safety and mode-of-action data for TGN1412—an anti-CD28 …
Establishing risk of human experimentation with drugs: lessons from TGN1412
MJH Kenter, AF Cohen - The Lancet, 2006 - thelancet.com
Administration of a chemical or biological compound to a human being is never without risk.
Although knowledge about risks increases during the development process, risks are still …
Although knowledge about risks increases during the development process, risks are still …
Risk in drug trials
D Focosi - The Lancet, 2006 - thelancet.com
The severe side-effects seen in the clinical trial of TGN14121, 2 were not seen in preclinical
tests on non-human primates. 3 Apart from differences in affinity and percentages of memory …
tests on non-human primates. 3 Apart from differences in affinity and percentages of memory …
[HTML][HTML] Risk in drug trials
MR Barnes, J Holbrook, JA Feild, DB Searls… - The Lancet, 2006 - thelancet.com
In their scientific analysis of the disastrous TGN1412 trial, MJH Kenter and AF Cohen (Oct
14, p 1390) 1 conclude that “the antibody was a high-risk compound unlikely to be suitable …
14, p 1390) 1 conclude that “the antibody was a high-risk compound unlikely to be suitable …
Risk in drug trials
In their scientific analysis of the disastrous TGN1412 trial, MJH Kenter and AF Cohen (Oct
14, p 1390) 1 conclude that “the antibody was a high-risk compound unlikely to be suitable …
14, p 1390) 1 conclude that “the antibody was a high-risk compound unlikely to be suitable …
Risk in drug trials
J Sugarman, C Levine - Lancet, 2006 - thelancet.com
In their scientific analysis of the disastrous TGN1412 trial, MJH Kenter and AF Cohen (Oct
14, p 1390) 1 conclude that “the antibody was a high-risk compound unlikely to be suitable …
14, p 1390) 1 conclude that “the antibody was a high-risk compound unlikely to be suitable …
The CONFIDeNT trial
A Hotouras, Y Ribas, M Allison, J Murphy - The Lancet, 2016 - thelancet.com
The Article by Charles Knowles and colleagues (Oct 24, p 1640) 1 reports outcomes that are
different from those initially registered. 2 The Article reports the single prespecified primary …
different from those initially registered. 2 The Article reports the single prespecified primary …
Methods to overcome vaccine hesitancy
2 UN Economic and Social Council. Annexes to the list of issues in relation to the sixth
periodic report of Germany. Replies of Germany to the list of issues. New York, NY: United …
periodic report of Germany. Replies of Germany to the list of issues. New York, NY: United …
Minimising risk in first-in-man trials
J Hemelaar - The Lancet, 2007 - thelancet.com
Comment www. thelancet. com Vol 369 May 5, 2007 1497 infusions would clearly have
been beneficial. The regimen was explained to volunteers as:“For practical reasons, the time …
been beneficial. The regimen was explained to volunteers as:“For practical reasons, the time …