In 2006 the TGN1412 clinical trial was suddenly aborted due to a very strong cyto-toxic
reaction of the six volunteers who were treated with the drug candidate. An Expert
Scientific Group on Clinical Trials as well as the RSS Working Party wrote reports on
what happened, how this could have been avoided and what to recommend for future trials
of this kind. I will present some work related to designs of such trials, in particular
my work on adaptive design of experiments. I will also present some recommendations of
the RSS Working Group (Senn et al. 2007).
Senn, S., Amin, D., Bailey, R.A., Bird, S.M., Bogacka, B., Colman, P., Garrett, A., Grieve, A., Lachmann, P. (2007).
Statistical Issues in first-in-man studies. JRSS A.