The therapeutic trial comparing extracorporeal membrane oxygenation with conventional treatment in neonatal respiratory failure reported by Bartlett et al (Pediatrics 1985;76:479-487) uses a method of comparing treatments unlikely to be familiar to most pediatricians. Known as the "randomized play the winner" method, it has thus far been little used in clinical research. Most clinical investigators consider the conventional randomized clinical trial to be the last word in treatment comparisons.
But randomized clinical trials are costly, cumbersome, and to some observers less than ideal ethically. The ethical problem arises from the fact that during a "successful" randomized clinical trial (ie, one that demonstrates a significant advantage to one treatment) about half of the trial subjects will receive a treatment which, at the end of the trial, will be known to be inferior.
Antithrombin supplementation during extracorporeal membrane oxygenation: study protocol for a pilot randomized clinical trial
