Biotech Values

[genisi]

that is one of the weirder trial protocols I've ever seen

The weird thing to me is the logic of null and alternative hypotheses which is reversed to what we are used to in efficacy design. Found this kind of futility studies in stroke* (a single-arm phase II study), in ALS** (a phase II, randomized, placebo-controlled, double-blind), and PD (former post). All had relatively small sample size and this is the only advantage I see in these protocols when used for screening drugs.

* http://stroke.ahajournals.org/content/36/11/2410.abstract?ijkey=5aa201f4798f1902bad324a562b9a364003fb3af&keytype2=tf_ipsecsha

** http://www.ncbi.nlm.nih.gov/pubmed/16534103